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Job DescriptionAbout Vitalief Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. Our team combines deep clinical research expertise with results-driven consulting to help organizations operate more efficiently and grow sustainably. The Role We are seeking an experienced Clinical Research Nurse to join our exceptional team as a full-time Vitalief employee. In this role, you will support a leading academic research center in Philadelphia, managing high-priority interventional clinical studies across multiple therapeutic areas. WHY VITALIEF? • Contribute to advancing scientific discoveries that improve patient lives., • PEOPLE FIRST culture with opportunities for growth and innovation., • Competitive benefits including: 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans., • Hybrid schedule: 4 days on-site (Philadelphia), 1 day remote weekly., • Under the direction of the Director and Clinical Investigators, this role will support the planning, implementation, and execution of multiple concurrent clinical research studies, including NIH-sponsored, industry-sponsored, and investigator-initiated trials., • Work independently managing day-to-day research activities from study start-up to close-out., • Act as liaison between investigators, research teams, and sponsors to ensure timely delivery of services., • Perform nursing assessments and procedures, such as conducting comprehensive nursing assessments, obtain vital signs, review medications, document patient information/instructions in the medical record, complete appropriate forms., • Perform any procedures required for the patient such as drawing blood, conducting EKG's etc., • Collect and interpret clinical and research information related to the patient visit., • Appropriately field/triage patient telephone calls regarding medication changes, clinical status, prescription renewals, or changes in condition., • Coordinate patient recruitment, enrollment, consent, and retention., • Schedule and conduct participant study visits, maintain databases, and ensure accurate data collection/entry., • Manage regulatory binders, IRB submissions, and compliance with FDA, IRB, and GCP guidelines., • Monitor safety events, prepare reports, and support sponsor/audit visits., • Maintain study records (OnCore, Epic, ClinicalTrials.gov) and oversee research billing reviews., • Assess and report study patients appropriately for serious/unexpected adverse events (SAEs)., • Consistently meet or exceed enrollment targets., • Professional licensure as a Registered Nurse in the Commonwealth of PA., • Preferred Education: Bachelor’s degree in Nursing or health-related field., • Phlebotomy certification., • ACLS or BLS certification is preferred., • Two (2) or more years of experience as a nurse in a hospital setting., • Some experience in a clinical trials setting is required such as patient recruitment/retention, IRB submissions, data management, and SAE reporting., • Proficiency with Electronic Health Records (Epic preferred) and Clinical Trial Management Systems (OnCore preferred)., • Strong Microsoft Office skills (Word, Excel, PowerPoint)., • Excellent written and verbal communication skills; ability to work effectively with diverse populations including faculty, staff, sponsors, and research participants., • Compassionate, professional demeanor and confident with patient education, translating complex concepts into understandable language., • Critical thinker with a proactive, detail-oriented mindset., • Highly organized, detail-oriented, and able to manage multiple priorities in a fast-paced environment. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. Powered by JazzHR DXnS8TKjwK

Job Description JOB DESCRIPTION A large hospital system is seeking a Clinical Research Nurse to join its cancer center and lead the launch of a new theranostics (theragnostics) program, which integrates advanced diagnostic tools with clinical trial treatments. This pivotal role requires someone eager to build the program from the ground up and serve as its driving force. The nurse will coordinate and implement oncology clinical trials, overseeing subject recruitment, data management, patient education, and regulatory compliance. Additional responsibilities include serving as a liaison between clinical and research teams, educating patients about study participation, collecting clinical data, and ensuring strict adherence to protocol requirements for emerging cancer therapies. REQUIRED SKILLS AND EXPERIENCE -2 years of experience working as a Clinical Research Nurse or a Radiology Nurse with oncology experience -Experience working with patients to collect/ document information and provide education regarding the research study -Experience organizing meetings to track and record the progress of clinical trials -PA RN License Required -Nursing Diploma or Associate's Degree in Nursing. BSN Preferred. Company DescriptionAt Insight Global, we’re more than just a staffing agency — we’re a people-first solutions firm that believes in the power of connection. With a nationwide presence and a reputation built on trust, integrity, and results, we specialize in placing top-tier talent across healthcare, IT, education, engineering, and professional services.At Insight Global, we’re more than just a staffing agency — we’re a people-first solutions firm that believes in the power of connection. With a nationwide presence and a reputation built on trust, integrity, and results, we specialize in placing top-tier talent across healthcare, IT, education, engineering, and professional services.

Job Description Job Title: Clinical Team Lead~ Oncology Research Location: Center City, Philadelphia Job Description We are seeking a dedicated Clinical Team Lead to manage and oversee clinical trials from startup to closeout. This role involves protocol coordination, feasibility planning, data management, and biological specimen management. The successful candidate will ensure all study procedures are conducted according to protocol and applicable regulations, train and supervise research staff, and contribute to standard operating procedures. This position also involves representing the organization internally and externally, overseeing research operations, and providing expert consulting at an institutional level. Responsibilities • Conduct clinical trials from startup to closeout independently., • Coordinate protocols, including screening, recruiting, enrolling, and consenting., • Plan feasibility studies and manage data and biological specimens., • Prepare for monitoring visits and regulatory and IRB document preparation., • Ensure study procedures adhere to protocols and regulations., • Train and supervise research staff and oversee clinical trial operations., • Develop and contribute to standard operating procedures and processes., • Attend leadership meetings and represent the organization internally and externally., • Experience in clinical trial and oncology., • Patient recruitment and clinical research experience., • Project management and clinical development skills., • Oncology or complex drug study experience., • Experience training and mentoring staff., • Oncology experience preferred., • Experience in training and mentoring incoming staff. This is a Contract to Hire position based out of Philadelphia, Pennsylvania. This role will have hybrid flexibility Pay and Benefits The pay range for this position is $30.00 - $38.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Philadelphia,PA. Application Deadline This position is anticipated to close on Oct 27, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Job DescriptionAbout Vitalief Vitalief partners with Sites, Sponsors, and CROs to streamline research operations, reduce costs, and accelerate breakthroughs that improve patient care. Our team combines deep clinical research expertise with results-driven consulting to help organizations operate more efficiently and grow sustainably. The Role We are seeking an experienced Clinical Research Coordinator (CRC) to join our exceptional team as a full-time Vitalief employee. In this role, you will support a leading academic research center in Philadelphia, managing high-priority interventional clinical studies across multiple therapeutic areas. WHY VITALIEF? • Contribute to advancing scientific discoveries that improve patient lives., • PEOPLE FIRST culture with opportunities for growth and innovation., • Competitive benefits including: 20 PTO days + 9 paid holidays; Company-paid life insurance and short/long-term disability; 401(k) retirement program; Comprehensive healthcare plans., • Hybrid schedule: 4 days on-site (Philadelphia), 1 day remote weekly., • Under the direction of the Director and Clinical Investigators, this role will support the planning, implementation, and execution of multiple concurrent clinical research studies, including NIH-sponsored, industry-sponsored, and investigator-initiated trials., • Work independently managing day-to-day research activities from study start-up to close-out., • Act as liaison between investigators, research teams, and sponsors to ensure timely delivery of services., • Coordinate patient recruitment, enrollment, consent, and retention., • Schedule and conduct participant study visits, maintain databases, and ensure accurate data collection/entry., • Manage regulatory binders, IRB submissions, and compliance with FDA, IRB, and GCP guidelines., • Monitor safety events, prepare reports, and support sponsor/audit visits., • Maintain study records (OnCore, Epic, ClinicalTrials.gov) and oversee research billing reviews., • Assess and report study patients appropriately for serious/unexpected adverse events (SAEs)., • Bachelor’s degree (healthcare or related field preferred)., • Minimum of two (2) to four (4) years of clinical research coordination experience (academic/institutional site experience preferred)., • Strong knowledge of GCP, FDA, and IRB regulations., • Experience in patient recruitment/retention, IRB submissions, data management, and SAE reporting., • Proficiency with Electronic Health Records (Epic preferred) and Clinical Trial Management Systems (OnCore preferred)., • Strong Microsoft Office skills (Word, Excel, PowerPoint)., • Excellent written and verbal communication skills; ability to work effectively with diverse populations including faculty, staff, sponsors, and research participants., • Highly organized, detail-oriented, and able to manage multiple priorities in a fast-paced environment., • Proactive, adaptable, and self-motivated with a positive, “can do” attitude., • Compassionate, professional demeanor with strong patient interaction skills. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. #LI-DNP Powered by JazzHR MV2N0LilOS

Job Description Position Summary: The Behavioral Health and Justice Division (BHJD) is committed to working towards reducing criminal justice involvement for Philadelphians with behavioral health challenges, including Serious Mental Illness (SMI). BHJD organizes its work according to the Sequential Intercept Model, identifying opportunities to intervene at various points of criminal justice involvement to deflect and divert individuals away from further penetration of the system and into the behavioral health system. By helping connect individuals to needed treatment and support services that promote stability in the community, BHJD believes that Philadelphians are less likely to be arrested and can achieve health, well-being, and self-determination. BHJD also aligns with Stepping Up and focuses its efforts on lowering the number of Philadelphians with SMI admitted to the Philadelphia Department of Prisons (PDP), reducing their length of stay, connecting them to treatment/supports upon release, and reducing recidivism. The Forensic Support Team (FST) of BHJD was established to meet the unique needs of Philadelphians who are either: 1. Adjudicated as not competent to stand trial on only misdemeanor charges and committed to a State hospital (e.g., Norristown State Hospital) or 2. Adjudicated as non-restorable. The FST works within PDP and Norristown State Hospital (NSH) in order to assist individuals while in jail, when transitioning from jail to NSH, and when reentering the community typically under the court’s jurisdiction. To support this forensic population, the FST helps individuals navigate the Philadelphia judicial and behavioral health systems while also seeking to address each individual’s unique legal, behavioral, medical, physical, cultural, and/or financial needs. The Clinical Assessor becomes an important part of a team comprised of: one (1) FST Supervisor (a licensed psychologist); one (1) FST Coordinator, three (3) Clinical Assessors, and one (1) Post-Doctoral Psychology Resident. The Clinical Assessor will complete clinical assessments and provide system navigation for justice-involved individuals with behavioral health challenges who fall into either of the aforementioned priority groups. In this capacity, the Clinical Assessor is responsible for determining the appropriate level of care (LOC) for the individual via a procedure that is consistent with a strengths-based, biopsychosocial recovery model. The procedure relies on State hospitals and jails to provide access to the individual as well as clear documentation and consultation about the individual so an informed decision can be made about the appropriate LOC and the individual’s risk for violence. The decision about the LOC is based on the individual’s: aspirations, goals for recovery, strengths, support system, risk for future violence, psychiatric diagnosis, medical diagnosis, psychiatric history, cognitive or physical limitations, results from any psychological measures or medical tests, current medications, incident reports, participation in recovery services, current treatment team input, and privileges earned. With this information and documentation, the Clinician Assessor collaborates with the Philadelphian and their treatment team in an effort to agree on an appropriate LOC as well as a re-entry plan and, when necessary, present the plan to the appropriate criminal court. Duties and Responsibilities: The Clinical Assessor helps individuals with SMI "navigate" the maze of treatment programs, the court system, and support services upon reentry into the community. The Clinical Assessor reduces barriers that keep individuals with SMI from accessing timely treatment by identifying behavioral health needs and directing individuals to appropriate resources. An effective Clinical Assessor is a: Relationship builder Building effective working relationships is the foundation of effective forensic navigation. To improve coordination of care for people with mental illness and to reduce barriers to reentry, navigators must work with different groups of people: individuals who are incarcerated, healthcare teams within the PDP, criminal justice partners, families, NSH staff, and resource providers within the community. It is important to build effective working relationships with all of these groups. Clinical care coordinator The Clinical Assessor conducts forensic evaluations and coordinate care for individuals who are either: 1. Adjudicated as not competent to stand trial on only misdemeanor charges and committed to a State hospital (e.g., NSH) or 2. Adjudicated as non-restorable. They coordinate with the court system, NSH, and treatment providers to determine the most appropriate and effective interventions and levels of care, and they provide the needed linkages. They plan reentry for individuals who will be returning to the community. Moreover, Clinical Assessors enhance the continuity of care as individuals transition between PDP and NSH. Creative problem solver The Clinical Assessor finds creative solutions to barriers. Some individuals with mental illness utilize commonly used services, but others have unique needs that require initiative and creative thinking to locate the appropriate resources. Organized information manager The Clinical Assessor manages and tracks a large amount of information. Assessments, referrals, legal statuses, and treatment histories are just a few things the Clinical Assessor needs to track and, by law, this information must be kept confidential and secure. It is important that the Clinical Assessor stays organized and uses a systematic approach to information management. Specific duties • Perform level of care and other-discharge related assessments for individuals adjudicated not competent to stand trial and/or non-restorable that are detained at the PDP or NSH, • Attend treatment team meetings for individuals detained at NSH to monitor progress and/or changes in clinical presentation, • Facilitate access to re-entry services and programs, • Identify individuals for diversion and share with appropriate justice partners, • Review legal status, commitment type, charges, competency opinions and findings, and clinical needs for all individuals on the waitlist to NSH on an ongoing basis, • Maintain accurate, confidential records documenting services provided and unmet needs using appropriate databases, • Remain current with resource and referral information, • Maintain list of community resources, • Build and maintain relationships with key individuals (e.g., PDP staff, Public Defender), and provide updates upon marked changes in an individual’s clinical or legal status to trigger appropriate interventions, • Coordinate with courts to ensure timely court hearings and legal proceedings, particularly when an individual’s clinical or legal status changes, • Provide behavioral health literacy and continuity of care training to both behavioral health providers and criminal justice personnel, • Provide updated progress reports for criminal court hearings and attend those hearings when necessary This position requires a master’s level degree in social work, psychology, or a related clinical focused field with at least two years of experience working with individuals with serious mental illness and/or in clinical-forensic assessment. Knowledge of and experience in working with the Philadelphia criminal justice system and/or the Philadelphia behavioral health system are preferred. The position requires demonstrated skills in communication, problem solving, decision making, and report writing. The individual possesses the ability to skillfully communicate verbally and in writing with a variety of multidisciplinary partners, including judges, attorneys, jail staff, provider agencies, psychiatrists, nurses, and social workers. Physical Demands: Ability to physically perform the duties and to work in the environmental conditions required such as maneuvering in office space – reaching file cabinets, fax and copier machines when necessary. Must be able to sit for up to 2 hours looking at a computer monitor and using a keyboard and mouse to perform data entry functions. Able to travel locally via public transportation and on foot from 1601 Market Street to 1101 Market Street, CBH, and various other destinations as needed. Essential Functions: Valid driver’s license and use of personal licensed and insured vehicle during work hours or ability to navigate public transportation to attend sites in person throughout the city. Ability to effectively utilize computers, databases, and related common office software packages such as Microsoft Word, Excel, and PowerPoint. Ability to pass all background checks required. Equal Opportunity Employment: PMHCC is committed to equal opportunity. It is our policy to support equal employment for all employees and applicants without regard to race, religion, color, sex, sexual preferences, age, national origin, disability, behavioral health status, military status or any other characteristic protected by law. Americans with Disabilities Act: Employees as well as applicants who are currently or become disabled must be able to perform the functions of the job with either reasonable accommodation or unaided. PMHCC will examine reasonable accommodations on a case-by-case basis with accordance to the law.

Job Description Position Summary: The Forensic Behavioral Health Navigator supports individuals to help them remain successfully in the community, helps individuals connect to service to assist from further penetration in the criminal justice system, provides connections to service serve as alternatives to arrest and incarceration, supports community reentry from incarceration. This position will be based at the Reentry trailer on the PDP campus. The Forensic Behavioral Health Navigator will serve all programs offered by the Behavioral Health and Justice Division of the Philadelphia Department of Behavioral Health and Intellectual disAbility Services (DBHIDS) which are at the intersection of the behavioral health and criminal justice. Navigators will specialize in work at one intercept point (i.e., police, pre-trial, jail reentry, probation and parole), and will work across these intercepts in response to the needs of the population of justice-involved individuals with behavioral health needs. Duties and Responsibilities: Forensic navigators help individuals with mental illness "navigate" the maze of treatment programs, the court system, and community support services for successful lives in the community. Navigators reduce barriers that keep individuals with mental illness from getting timely treatment by identifying behavioral health needs and diverting individuals to appropriate resources and away from jail. Specific duties include: • Critical point of engagement for individuals upon release from local custody., • Services as pivotal role in coordinating services, • Acts as trusted source for individuals seeking support, • Real-time access to the Kensington Wellness Support Center team for transportation/ rideshare needs and other supports, • Provide a calm listening ear and constructive support, • Facilitating linkages to community treatment and outside support systems, • Assists with referrals to obtain Medical Assistance, • Assists with referrals to obtain case management, • Arrange appointments for behavioral health, medical, and other care services, • Works in person at various locations such as the Reentry trailer, CJC, and Pretrial Services This position requires strong clinical skills, case management skills, and an ability to navigate systems of care, the criminal justice system, and community resources • Strong clinical and case management skills, • Demonstrated understanding of and ability to navigate the behavioral health and criminal justice systems in Philadelphia, • Knowledge of mental health disorders, substance use disorders, and co-occurring challenges, • Knowledge of how behavioral health issues intersect with the criminal justice system in the City of Philadelphia, • Cross-cultural skills and experience with culturally diverse populations. Recovery experience preferred., • Knowledge of benefits, how to activate benefits, and how to leverage benefits to access treatment and resources, • Demonstrated excellence in written and oral communication skills. Knowledge of multiple languages a plus, • Demonstrated ability to establish and maintain effective working relationships, • Recognizing signs and symptoms of mental illness, • Understanding medications, • Understanding special populations, • Connecting with families and consumers, • Employing de-escalation techniques to improve and manage behavior Bachelor's degree in social work, psychology or related clinical field with at least 2 years of experience working with individuals with serious mental illness. Candidates must have a working knowledge of the Philadelphia Behavioral Health and Criminal Justice Systems Essential Functions: • Work to strengthen collaboration between BHJD/DBHIDS and other city agencies, including the Philadelphia Municipal Court and Court of Common Pleas, Philadelphia Police Department, Philadelphia District Attorney's Office, Defender Association of Philadelphia,, City of Philadelphia Department of Prisons, • Provide high level of timely and effective communication with internal and external partners to ensure program goals and objectives are met, • Conduct screenings and assessments and provide treatment plans based on individual needs for program participants, • Complete behavioral health treatment/ service history research for participants, where appropriate, • Facilitate linkages to appropriate treatment providers and other social services based on the needs of the participant, • Network with area community providers and provide resource coordination, • Activate maximum benefits (e.g. Medicaid, SSI) for individuals so they can access needed services and supports, • Interface with criminal justice representatives as needed to support the goals of each BHJD/DBHIDS program, • Enter and maintain clinical and program data, • Maintain accurate, confidential records to document services provided using appropriate databases, • Remain current with resource and referral information, • Attend and participate in staff meetings and supervision PMHCC, Inc. is committed to equal opportunity. It is our policy to support equal employment for all employees and applicants without regard to race, religion, color, sex, sexual preferences, age, national origin, disability, behavioral health status, military status or any other characteristic protected by law. Americans with Disabilities Act: Employees as well as applicants who are currently, or become disabled, must be able to perform the functions of the job with either reasonable accommodation or unaided. PMHCC, Inc. will examine reasonable accommodations on a case by case basis in accordance with the law.

Job Description Position Summary: The Forensic Behavioral Health Navigator supports individuals to help them remain successfully in the community, helps individuals connect to service to assist from further penetration in the criminal justice system, provides connections to services serve as alternatives to arrect and incarceration, and supports community reentry from incarceration. This position will provide dedicated support to court-appointed counsel representing individuals in local custody. The forensic behavioral health navigator will serve all programs offered by the Behavioral Health and Justice Division of the Philadelphia Department of Behavioral Health and Intellectual disAbility Services (DBHIDS) which are at the intersection of the behavioral health and criminal justice. Navigators will specialize in work at the one intercept point (i.e., police, pre-trial, jail reentry, probation and parole), and will work across intercepts in response to the needs of the population of justice involved individuals with behavioral health needs. Duties and Responsibilities: Forensic navigators help individuals with mental illness "navigate" the maze of treatment programs, the court system, and community support services for successful lives in the community. Navigators reduce barriers that keep individuals with mental illness from getting timely treatment by identifying behavioral health needs and diverting individuals to appropriate resources and away from jail. Specific duties include: • Support court appointed counsel for individuals in local custody, • Provide significant value by assisting counsel in navigating the behavioral health system on behalf of their clients, • Offers insight into reducing unnecessarily long lengths of stay for clients, • Provides a calm listening ear and constructive support., • Facilitating linkages to community treatment and outside support systems, • Assists with referrals to obtain Medical Assistance, • Assists with referrals to obtain case management, • Arrange appointments for behavioral health, medical, and other care and services, • Works in person at various locations such as FJD, CJC, Pretrial services and Reentry trailer This position requires strong clinical skills, case management skills, and an ability to navigate systems of care, the criminal justice system, and community resources • Strong clinical and case management skills, • Demonstrated understanding of and ability to navigate the behavioral health and criminal justice systems in Philadelphia, • Knowledge of mental health disorders, substance use disorders, and co-occurring challenges, • Knowledge of how behavioral health issues intersect with the criminal justice system in the City of Philadelphia, • Cross-cultural skills and experience with culturally diverse populations. Recovery experience preferred, • Knowledge of benefits, how to activate benefits, and how to leverage benefits to access treatment and resources, • Demonstrated excellence in written and oral communication skills, Knowledge of multiple languages a plus, • Demonstrated ability to establish and maintain effective working relationships., • Recognizing signs and systems of mental illness, • Understanding medications, • Understanding special populations, • Connecting with families and consumers, • Employing de-escalation techniques to improve and manager behavior Bachelor's degree in social work, psychology or a related clinical field with at least 2 years of experience working with individuals with serious mental illness Candidates must have a working knowledge of the Philadelphia Behavioral Health and Criminal Justice systems Essential Functions: • Provide high level of timely and effective communication with internal and external partners to ensure program goals and objectives are met., • Conduct screenings and assessments and provide treatment plans based on individual needs for program participants, • complete behavioral health treatment/ service history research for participants, where appropriate, • Facilitate linkages to appropriate treatment providers and other social services based on the needs of the participant, • Network with area community providers and provide resource coordination, • Activate maximum benefits for individuals so they care access needed services and support, • Interface with criminal justice representatives as needed to support the goals of each BHJD program, • Enter and maintain clinical and program data, • Maintain accurate, confidential records to document services provided using appropriate databases PMHCC is committed to equal opportunity. It is our policy to support equal employment for all employees and applicants without regard to race, religion, color, sex, sexual preferences, age, national origin, disability, behavioral health status, military status or any other characteristic protected by law. Americans with Disabilities Act: Employees as well as applications who are currently, or become disabled, must be able to perform the functions of the job with either reasonable accommodation or unaided. PMHCC, Inc will examine reasonable accommodations on a case by case basis in accordance with the law.

Job Description Position Summary: The Behavioral Health and Justice Division (BHJD) is committed to working towards reducing criminal justice involvement for Philadelphians with behavioral health challenges, including Serious Mental Illness (SMI). BHJD organizes its work according to the Sequential Intercept Model, identifying opportunities to intervene at various points of criminal justice system involvement to deflect and divert individuals away from further penetration of the system and into the behavioral health system. By helping connect individuals to needed treatment and support services that promote stability in the community, BHJD believes that Philadelphians are less likely to be arrested and can achieve health, well-being, and self-determination. BHJD also aligns with Stepping Up and focuses its efforts on lowering the number of Philadelphians with SMI admitted to the Philadelphia Department of Prisons (PDP), reducing their length of stay, connecting them to treatment/supports upon release, and reducing recidivism. The Forensic Support Team (FST) of BHJD was established to meet the unique needs of Philadelphians who are adjudicated not competent to stand trial. The Staff Psychologist & FST Coordinator is a part of this team, which was created to work within the Philadelphia Department of Prisons (PDP) and Norristown State Hospital (NSH) in order to assist individuals while in jail, when transitioning from jail to NSH, and when re-entering the community typically under the court’s jurisdiction. To support this forensic population, the FST and the Staff Psychologist & FST Coordinator help individuals navigate the Philadelphia judicial and behavioral health systems while also seeking to address each individual’s unique legal, behavioral, medical, physical, cultural, and/or financial needs. The Staff Psychologist & FST Coordinator becomes an important part of a team comprised of: one (1) FST Supervisor (a licensed psychologist); three (3) Clinical Assessors, and one (1) Post-Doctoral Resident. The Staff Psychologist & FST Coordinator functions to coordinate activities of the FST in addition to completing clinical assessments and system navigation for justice-involved individuals with behavioral health challenges. The Staff Psychologist & FST Coordinator is responsible for orienting new team members, supervising Master’s or Bachelor’s level interns, taking the lead on team initiatives, facilitating internal or external meetings, and assisting with community-referred evaluations. The Staff Psychologist & FST Coordinator also assists the FST Supervisor with review of the team’s evaluations. The Staff Psychologist & FST Coordinator can also provide ad-hoc/booster training to enhance the forensic report writing of Masters-level clinicians. This provides an extra layer of quality control and improvement in report writing, allowing a senior FST member to support skill development in other FST members. In addition, since FST is part of BHJD, the Staff Psychologist & FST Coordinator would be expected to assist with division-wide projects that could encompass behavioral health, justice-related programs or initiatives overseen by BHJD. Duties and Responsibilities: The Staff Psychologist & FST Coordinator will utilize their experience and knowledge in the field to assist individuals who have been adjudicated not competent to stand trial (IST) and/or non-restorable due to severe mental illness and criminal justice involvement. More specifically, the Staff Psychologist & FST Coordinator will help these individuals and the individual’s support system to navigate PDP, NSH, the court system, residential programs (if needed), and support services upon reentry into the community. He or she will also reduce barriers that keep these individuals with mental illness and criminal justice involvement from accessing timely treatment by identifying behavioral health needs and directing individuals to appropriate resources. To be successful in this role, the Staff Psychologist & FST Coordinator must be: Relationship builder: Building and maintaining effective working relationships is the foundation of effective forensic navigation. The Staff Psychologist & FST Coordinator will continue to build upon existing relationships and utilize those relationships to improve coordination of care and reduce barriers for re-entry for people with mental illness who are involved with the legal system. The Clinical Assessors, and especially the Staff Psychologist & FST Coordinator, have collaborative working relationships with several different groups of people: individuals who are incarcerated, the individual’s family members, healthcare teams within PDP, assistant district attorneys, defense attorneys, criminal court officials, Norristown State Hospital staff, and resource providers within the community. The Staff Psychologist & FST Coordinator will also be asked to orient and introduce new staff members to these systems. When orienting staff or building work relationships, the Staff Psychologist & FST Coordinator is expected to practice cultural humility. Clinical care coordinator The Staff Psychologist & FST Coordinator conducts forensic evaluations and coordinates care for individuals who are adjudicated not competent and/or non-restorable in Philadelphia. They coordinate with the court system, NSH, and treatment providers to determine the most clinically as well as culturally appropriate and effective interventions and levels of care, and they provide the needed linkages. They plan re-entry for individuals who will be returning to the community. Moreover, the FST Coordinator enhances the continuity of care as individuals transition between PDP, NSH and the community. They may be tasked with assisting other members of the team with cases as appropriate. Creative problem solver The Staff Psychologist & FST Coordinator finds creative solutions to barriers. Some individuals with mental illness utilize commonly used services, but others have unique needs that require initiative and creative thinking to locate the appropriate resources. The Staff Psychologist & FST Coordinator will utilize their years of experience and educational resources gained through licensure to locate and access such resources. Organized information manager The Staff Psychologist & FST Coordinator manages and tracks a large amount of information about each individual that he or she evaluates and the multiple systems that each individual must navigate. He/she will monitor referrals, evaluations, legal statuses, and treatment histories of Philadelphians who are adjudicated not competent and/or non-restorable. In addition, the Staff Psychologist & FST Coordinator will be tasked with assisting the FST Supervisor with tracking challenging cases, initiating clinical follow-up and taking the lead on organizational charts. By law, this information must be kept confidential and secure. It is important that the Staff Psychologist & FST Coordinator understands how to ethically manage this information with a professional and systematic approach. Peer Supervision and Training The Staff Psychologist & FST Coordinator assists the FST Supervisor with review of the team’s evaluations. This allows team members to receive support from a senior team member in developing their writing style and learning best principles of forensic report writing. The Staff Psychologist & FST Coordinator will also work with the FST Supervisor to address areas of improvement for reports and provide individualized training to help build staff report writing skills. Specific duties: • Perform Level of Care and other-discharge related assessments for individuals adjudicated not competent and/or non-restorable that are detained at the PDP or NSH, • Conduct psychologist testing for complex clinical referrals, including assessment of individuals with potential neurocognitive or neurodevelopmental conditions, assessment of individuals with personality disorders, and assessment of individuals with severe and unremitting serious mental illness, • Attend treatment team meetings for individuals detained at NSH to monitor progress and/or changes in clinical presentation, • Facilitate access to re-entry services and programs, • Identify individuals for diversion and share with appropriate justice partners, • Review legal status, commitment type, charges, competency opinions and findings, and clinical needs for all individuals on the waitlist to NSH on an ongoing basis, • Maintain accurate, confidential records documenting services provided and unmet needs using appropriate databases, • Remain current with resource and referral information, • Maintain list of community resources, • Alert key individuals (e.g., PDP staff, Public Defender) upon marked changes in clinical or legal status to trigger appropriate interventions, • Coordinate with courts to ensure timely court hearings and legal proceedings, particularly when an individual’s clinical or legal status changes, • Assist the FST Supervisor in managing and supervising the FST, including providing direct supervision to select Master’s-level Clinical Assessors, • Assist the FST Supervisor in serving as BHJD liaison to internal and external partners (e.g., IdS, CBH, TIP) Provide early-stage review of FST reports and identifying areas of report writing development for junior team members, • Provide individualized training to team members to assist in report writing skill development, • Build and maintain relationships with key staff, • Attendance at conferences to represent and support DBHIDS, • Identify gaps in re-entry resources offered and work to bridge those gaps, • Provide behavioral health literacy and continuity of care training to both behavioral health providers and criminal justice personnel Provide updated progress reports for criminal court hearings and attend those hearings when necessary. Assist with a division-wide projects, orientation of new Clinical Assessors, and supervision of a Master’s or Bachelor’s level intern (if applicable). In addition to the above responsibilities, the Staff Psychologist & FST Coordinator would also take the lead with team initiatives, facilitate internal or external meetings, and assist with community-referred evaluations. Education, Experience, and Skills Required: This position requires a doctoral degree in Psychology (Clinical, Counseling, or Educational; PsyD, PhD, or EdD), from an accredited program. Must be a Licensed Psychologist in Pennsylvania or license-eligible; employment is contingent upon licensure being granted. Strong preference for an individual with at least two years of experience in clinical-forensic assessment and/or violence risk assessment. Practicum, predoctoral internship, and postdoctoral residence/fellowship experience count towards this preference. Demonstrated skills in communication, problem solving, and decision making. Ability to skillfully communicate verbally and in writing with a variety of multidisciplinary partners, including judges, attorneys, jail staff, provider agencies, psychiatrists, nurses, and social workers. Supervision and leadership skills are preferred. Physical Demands: Ability to physically perform the duties and to work in the environmental conditions required such as maneuvering in office space – reaching file cabinets, fax and copier machines when necessary. Must be able to sit for up to 2 hours looking at a computer monitor and using a keyboard and mouse to perform data entry functions. Able to travel locally via public transportation and on foot from 1601 Market Street to 1101 Market Street, CBH, and various other destinations as needed. Essential Functions: Valid driver’s license and use of personal licensed and insured vehicle during work hours or ability to navigate public transportation to attend sites in person throughout the city. Ability to effectively utilize computers, databases, and related common office software packages such as Microsoft Word, Excel, and PowerPoint. Ability to pass all background checks required. Equal Opportunity Employment: PMHCC is committed to equal opportunity. It is our policy to support equal employment for all employees and applicants without regard to race, religion, color, sex, sexual preferences, age, national origin, disability, behavioral health status, military status or any other characteristic protected by law. Americans with Disabilities Act: Employees as well as applicants who are currently or become disabled must be able to perform the functions of the job with either reasonable accommodation or unaided. PMHCC will examine reasonable accommodations on a case-by-case basis with accordance to the law.

Job DescriptionAre you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn. This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position. Roles and Responsibilities: • Strong experience with development and writing of nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs), • Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity, • Ability to author based on highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data, • Ability to develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents, • Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data (eg, Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports), • Collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC, • Demonstrated ability to lead others to complete complex projects, • Ability to complete documents according to sponsor’s format, processes, and according to regulatory guidelines, • Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment, • Organizational expert within the nonclinical subject area, • Excellent written/oral communication and strong time and project management skills, • Ability to attend regular team meetings, lead client meeting and CRMs, • Ability to work in various client systems (eg, SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars, • Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP)Requirements:, • BS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control, • Knowledge of GLP, ICH guidelines, and applicable regulatory requirements, • 2+ years of pharmaceutical regulatory nonclinical writing experience, • Strong writing and analytical skills, • Proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred QENgznL5dy

Job Description Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit or follow MMS on LinkedIn. Responsibilities: • Interact with clients and regulatory authorities, remotely and onsite, including representation at key regulatory meetings on behalf of the client., • Demonstrated ability to lead/ manage multiple individuals and/or groups., • Cross-functionally collaborates and coordinates Transparency deliverables ensuring that timelines and milestones remain on-track and within target., • Strategically assesses resource utilization and forecasting to ensure companywide goals are met, • Effectively communicates complex strategic concepts with ability to tailor message to targeted audience., • Demonstrate thought leadership with customers by developing and presenting client industry trends, benchmarking, and other pertinent information. May participate in industry events for this purpose., • Demonstrated ability to lead / manage multiple individuals and/or groups in a global environment., • Directs strategic planning and proactively prepares contingency plans to address unforeseen challenges within group, and cross functionally to ensure uninterrupted delivery and maintain compliance., • Ability to facilitate positive group morale and productivity by appropriately including others in decisions/plans., • Manages staff, makes decisions and advises others on complex problems; understands intra- and inter-departmental implications of decisions and can develop strategic solutions with minimal input., • Direct, manage, and oversee the daily activities and workload of the transparency, PLS, and redaction teams., • Proactively identifies areas for improvement before issues arise and provides strategic proposal/resolution for consideration., • Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred., • Minimum of 6 years’ experience in clinical trial transparency, disclosure, or medical writing role, • At least 5 years of experience in a CRO environment., • Demonstrated managerial skills and experience preferred., • High level knowledge of drug development process, clinical development, and operations, with a strong understanding of regulatory guidelines., • Excellent scientific writing skills., • Excellent analytical, organizational, and problem-solving skills., • Proficiency with MS Office applications., • Strong communication and presentation skills., • Knowledge of ISO 9001, ISO 27001, 21 CFR Part 11, FDA, and GCP requirements, • Understanding of CROs and scientific & clinical data/ terminology, & the drug development process. Powered by JazzHR HVP5j87vGf

Job Description Sub-Investigator Key Responsibilities: • Assist the Principal Investigator (PI) in overseeing and managing clinical trials conducted at the research site, ensuring adherence to the study protocol, Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements., • Provide medical oversight and ensure the safety and well-being of study participants throughout the trial, under the supervision of the PI., • Perform delegated study-related duties as assigned by the PI, which may include comprehensive patient assessments, physical exams, medical histories, and eligibility screenings., • Review and interpret eligibility, laboratory results, ECGs, and other diagnostic tests as required by the protocol and under PI supervision., • Assist the PI in making medical decisions regarding participant care, adverse events, and protocol deviations., • Ensure accurate, complete, and timely collection and documentation of all study data., • Communicate effectively with the PI, study team, and, as delegated, with sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and regulatory authorities., • Assist with investigational product accountability, storage, and administration according to protocol., • Participate in site initiation visits, monitoring visits, audits, and inspections as required., • Maintain continuous medical education and stay current with advancements in clinical research and relevant therapeutic areas. Position Requirements: • Master’s degree in Nursing from an accredited program., • Current Nurse Practitioner certification (FNP, AGNP, or specialty certification) or Physician's Assistant (PA) certification and state licensure., • At least 3 years of experience in clinical research, either as a Sub-Investigator, research fellow, or similar role, with a strong understanding of clinical trial processes., • Demonstrated knowledge of ICH-GCP guidelines, FDA regulations, and other relevant ethical and regulatory requirements for clinical research., • Strong interpersonal and communication skills, with the ability to work effectively as part of a team., • Excellent clinical judgment and problem-solving abilities., • Meticulous attention to detail and strong organizational skills., • Ability to prioritize tasks and manage time efficiently., • Familiarity with clinical trial management systems (CTMS) and electronic data capture (EDC) systems is a plus., • Commitment to ethical conduct and patient safety. Location: This position requires NP travel to the location of the study/program participant/patient. Travel may be local or across state lines based on licensure to practice.

Job Description Principal Investigator Key Responsibilities: • Oversee and manage all aspects of clinical trials conducted at the research site, ensuring adherence to the study protocol, Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory requirements., • Provide medical oversight and ensure the safety and well-being of study participants throughout the trial., • Participate in the selection and evaluation of study protocols, ensuring feasibility and alignment with site capabilities., • Lead and supervise the clinical research team, including sub-investigators, study coordinators, and other site staff., • Delegate study-related duties appropriately to qualified personnel and ensure proper training and oversight., • Conduct remote review of patient assessments, including physical exams, medical histories, and eligibility screenings, to ensure appropriate participant enrollment., • Review and interpret laboratory results, ECGs, and other diagnostic tests., • Make critical medical decisions regarding participant care, adverse events, and protocol deviations., • Ensure accurate, complete, and timely collection and documentation of all study data., • Communicate effectively with sponsors, Contract Research Organizations (CROs), Institutional Review Boards (IRBs), and regulatory authorities., • Manage investigational product accountability, storage, and administration according to protocol and with the help of the on-site IP team., • Participate in site initiation visits, monitoring visits, audits, and inspections., • Maintain continuous medical education and stay current with advancements in clinical research and relevant therapeutic areas. Position Requirements: • Medical Doctor (M.D. or equivalent) degree from an accredited institution., • Current, unrestricted medical license in the state of practice., • Board certification in a relevant specialty preferred., • Experience (e.g., 5+ years) as a Principal Investigator or Sub-Investigator in clinical research trials across various therapeutic areas., • Demonstrated in-depth knowledge of ICH-GCP guidelines, FDA regulations, and other relevant ethical and regulatory requirements for clinical research., • Proven leadership and team management skills., • Excellent clinical judgment and decision-making abilities., • Strong verbal and written communication skills in English, with the ability to present complex information clearly and concisely., • Exceptional organizational skills and meticulous attention to detail., • Ability to manage multiple complex studies simultaneously and prioritize tasks effectively., • Commitment to ethical conduct and patient safety. Location: This position requires remote oversight of clinical research sites and may require occasional travel for meetings, conferences, or training 1 to 2 times per month.

Job Description Location: Remote Job Type: Full-time, Exempt Reports to: Chief Executive Officer Join Us at Civia Health The Director, Clinical Quality Assurance (CQA) will oversee quality assurance activities to ensure compliance with Good Clinical Practice (GCP), applicable regulations, and company SOPs. The role involves performing internal and site audits, hosting sponsor audits, overseeing Corrective and Preventive Actions (CAPA), drafting and maintaining SOPs, ongoing consultative support, and ensuring inspection readiness. This position will also establish, track, and report on key performance indicators (KPIs) related to quality compliance and audit readiness. At Civia Health, you're not just taking a job: You're joining a mission to transform the way clinical research is done. Our purpose is bold: to bring clinical trials front and center in your community, make them accessible to everyday people, and empower underrepresented communities to participate. We’re reinventing how clinical studies are run, delivering valid, scalable evidence with a consumer-first mindset. Too often, trials are expensive, fragmented, and overlook the experience of the participant. At Civia, we’re changing that. Our leadership team are experienced industry leading, visionary professionals who know what’s broken — and how to fix it. We treat participants like valued partners, not research subjects. That means supporting their agency, putting their needs, comfort, and enjoyment first — and rewarding them generously for their time and effort. What It Means to Work at Civia Every team member plays a crucial role in reshaping clinical research. You’ll help make studies more human-centered, inclusive, and efficient. We're looking for people who are driven by purpose, inspired by innovation, and ready to roll up their sleeves to do meaningful work. At Civia, your contributions aren’t just transactional, they’re transformational. What You’ll Do * Provide quality oversight of clinical trial activities to ensure compliance with GCP, regulatory requirements, and company SOPs. * Develop and implement quality assurance strategies to support continuous improvement across clinical operations with an emphasis on improving efficiency and compliance. * Lead inspection readiness initiatives and serve as the primary point of contact during sponsor audits and regulatory inspections. * Host and manage sponsor audits at the SMO, including coordinating logistics, preparing staff, and ensuring timely document provision. * Oversee audit follow-up activities, including drafting and reviewing responses, and ensure timely CAPA closure. * Lead the development, implementation, and effectiveness checks of CAPA plans arising from audits, inspections, or quality issues. * Ensure CAPAs are tracked, resolved, and documented in compliance with internal timelines and regulatory requirements. * Draft, review, and maintain SOPs to ensure alignment with GCP, regulations, and best practices. * Support the continuous improvement of the quality management system. * Define, track, and report KPIs related to quality assurance activities (e.g., CAPA closure timelines, audit/inspection readiness scores, SOP compliance rates). * Act as a key point of contact for quality-related inquiries from sponsors and internal stakeholders. What You Bring * Bachelor’s degree in life sciences, pharmacy, nursing, or related field (advanced degree preferred). * Minimum 5 years of clinical research experience within Site, CRO, or sponsor settings (experience in clinical QA required). * Experience hosting sponsor audits and preparing for regulatory inspections is strongly preferred. * Experience in CAPA management, SOP development, and quality system implementation. * Experience with KPI development, tracking, and reporting is an advantage. * Willingness to travel occasionally to other sites for study support. * Comprehensive understanding of ICH-GCP, 21 CFR Parts 11, 50, 56, 312, 812, HIPAA, and applicable FDA regulations. * Strong understanding of ICH-GCP, relevant FDA regulations, and clinical trial processes. * Strong knowledge of regulatory requirements for both U.S. and international clinical research preferred. * Excellent organizational, communication, and leadership skills. * Ability to lead cross-functional teams and manage multiple projects in a fast-paced environment. * Strong problem-solving and decision-making abilities. * Detail-oriented with a high standard for quality and compliance. * Self-motivated and strong work ethic * Strong time management skills * Ability to adapt, multi-task and prioritize * Teamwork and Communication What We Offer * Competitive compensation * Medical, dental, and vision insurance * Generous PTO and paid holidays * Flexible scheduling options * Professional development and continuing education support * A mission-driven team that values respect, inclusion, and innovation Ready to Make an Impact? * Mission with Meaning: Be part of a purpose-led team committed to health equity and real-world impact. * Startup Energy, Proven Expertise: Work fast, adapt quickly, and help build something new; guided by seasoned visionary professionals who’ve seen what needs to change. * People First Culture: We care deeply about our patients, participants, and each other. Collaboration, transparency, and bold, straight-talking are core to how we work. * Invested in Your Growth: We don’t just hire for today; we’re building the leaders and changemakers of tomorrow. If you’re ready to be part of something meaningful—and work with people who care deeply about doing good work—apply today by submitting your resume and cover letter to the link above. We’re excited to learn more about you! Powered by JazzHR P9eub5k1VR

This role requires a high level of independence, strong leadership skills, and expertise in clinical research operations, with a preference for experience in clinical trial design, epidemiology, and federally funded research. In addition to the above responsibilities, the Research Project Manager C

Catalent is a global leader in clinical supply services, working with clinical trial sponsors of all sizes to reliably supply their clinical trials. With 9 GMP facilities in the US, EU, and Asia/Pacific region, and more than 50 depots covering 6 continents, our Clinical & Specialty Services (CSS) se

Job DescriptionAbout MMS MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide. MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit or follow MMS on LinkedIn. This position requires proven Project Management experience in supporting marketing applications, as well as in the development and management of Risk Evaluation and Mitigation Strategies (REMS) programs. Responsibilities: • Understands various cost models and develops budgets for moderate complexity projects., • Ensures financial KPIs are achieved on assigned projects; invoices on-time and ensures alignment with the contracted payment schedule; updates revenue projections on assigned projects. Controls project scope via defined PM methodology and processes for change management., • Develops moderate complexity project timelines independently., • Performs advanced functions in MSP. Understands task constraints and conveys critical path milestones to the functional lead. Develops/input into strategies to help achieve timeline expectations., • Executes day-to-day activities during the course of a program/project including risk identification, issue escalation and resolution. Collaborates with functional line management to resolve any issues and trends., • Intermediate excel skills (Hlookup, Vlookup, Pivot Table, etc.)., • Drives customer satisfaction and works to strengthen client relationships. Develops an account growth plan and consults with line manager to achieve a 10% revenue growth annually (minimum). Manages minimum one key account., • Participates in or leads RFIs/RFPs in collaboration with proposals team. Participates in or leads capabilities meetings - at least 2 annually., • Participates in or leads bid defenses - at least 1 annually., • Proficient in Word, Outlook, PowerPoint., • Proficient in meeting facilitation including scheduling, development of agendas and meeting minutes; works with project leads to ensure meeting objectives are met., • Understands general requirements: ICH, 21CRF Part 11, and ISO 9001:2000.Responsibilities:, • Bachelor’s Degree required, or relevant work experience., • Minimum of 5 years’ experience in project coordination or project management or similar field required., • Expert knowledge of scientific principles and concepts., • Proficiency with MS Office applications., • Hands-on experience with clinical trial and pharmaceutical development preferred., • Good communication skills and willingness to work with others to clearly understand needs and solve problems., • Excellent problem-solving skills., • Good organizational and communication skills., • Familiarity with current ISO 9001 and ISO 27001 standards preferred., • Familiarity with 21 CFR Part 11, FDA, and GCP requirements. 3SO2b6o5eH

Job Description Working under the direction of the Senior Director, Clinical Research, the Senior Project Manager (SPM) will be responsible for the overall management of all projects including liaising between the funder and the project team for oncology clinical trials managed by the organization. The Senior Project Manager coordinates the efforts of all project teams to ensure that all aspects of all projects as defined in the contract are occurring on schedule and within budget. Ideal candidate will have registration trial experience as well as a data management background. Job Responsibilities • Assists the Sr. Director in all aspects of clinical trial management, • Reviews contract, protocol, budget and Case Report Forms (CRF's) in the development of the scope of the project, • Coordinates and oversees the development of project teams including members of Medical, Data Management, Regulatory, Monitoring, and Clinical Supplies departments as needed, • Oversees the development and implementation of the project plan, • Assures that all project tasks are performed per SOPs and integrated project-specific SOPs per the clinical trial sponsor, and includes the development, review and implementation of Project Specific Plans (PSPs)., • Provides overall direction for study issue resolution, • Communicates with management and fiscal personnel to ensure ongoing budget compliance through project completion, • Ensures that the study is in compliance with federal requirements, that data has been accurately reported and that all queries have been timely resolved, • Ensures that the project team communicates with funders, monitors, CRAs and sites to confirm that all protocol amendments, revisions to the Investigator’s Brochure and /or significant new adverse effects or risks with respect to study drugs are distributed to all participating sites, • Provides mentoring and training to junior staff including PMs, Associate PMs and CRAs, • Maintains a positive interaction with funders’ representatives, • Attends relevant meetings for sponsor-related activities, cooperative groups and the organization’s staff meetings, • Provides appropriate status reports to clinical trial sponsor, Sr. Director, Clinical Team Manager, and Vice President and communicate any problems at the site, especially those involving patient safety issues, • A minimum of ten (10) years strong health care related background with prior oncology clinical trial management and/or data management services experience is required., • Experience in pharmaceutical industry, contract research organization, site network and multisite trial management experience is required., • Bachelor's degree from an accredited college or university is required. An appropriate Master’s Degree and SOCRA certification is preferredCompany DescriptionThe Coalition of Cancer Cooperative Groups is a unique nonprofit organization with one mission, improving patient awareness of cancer clinical trials, facilitating access, and promoting participation. Through innovative programs and services, the Coalition examines and confronts key issues impeding cancer research. The Coalition of Cancer Cooperative Groups was established in 1997 to address improving the cancer clinical trials system. Today, the Coalition is comprised of members from National Cancer Institute-sponsored Cooperative Groups, the country's leading patient advocacy organizations, and thousands of oncology and cancer research specialists. The Coalition also works with its partners in the healthcare industry to streamline and promote cancer clinical trials in both the public and private sectors.The Coalition of Cancer Cooperative Groups is a unique nonprofit organization with one mission, improving patient awareness of cancer clinical trials, facilitating access, and promoting participation. Through innovative programs and services, the Coalition examines and confronts key issues impeding cancer research.\r\n\r\nThe Coalition of Cancer Cooperative Groups was established in 1997 to address improving the cancer clinical trials system. Today, the Coalition is comprised of members from National Cancer Institute-sponsored Cooperative Groups, the country's leading patient advocacy organizations, and thousands of oncology and cancer research specialists. The Coalition also works with its partners in the healthcare industry to streamline and promote cancer clinical trials in both the public and private sectors.