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Clinical Research Coordinator B/C

hace 16 días

Philadelphia

University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023. Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play. The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator B/C Job Profile Title Clinical Research Coordinator B Job Description Summary The Clinical Studies Unit (CSU) within the Department of Dermatology is seeking a highly motivated, organized, and detail-oriented Clinical Research Coordinator to support the fast-paced day-to-day operations of multiple investigator-initiated and industry-sponsored clinical trials focused on dermatologic diseases. The primary function of this position is to facilitate, promote, and ensure the conduct of high-quality clinical research in accordance with Good Clinical Practice (GCP), institutional policies, and regulatory requirements. Essential responsibilities include screening, recruitment, consent, and enrollment of study participants; coordination of protocol-required visits and assessments; accurate data collection, entry, and management; maintenance of regulatory and study documentation; and preparation and submission of materials to the Penn Biomedical Institutional Review Board (IRB) and central IRBs, as applicable. The Clinical Research Coordinator is responsible for supporting all phases of clinical trial execution, including study start-up, ongoing study conduct, monitoring, and close-out activities. The individual will work within a highly collaborative research environment alongside study coordinators, a regulatory specialist, project managers, investigators, and clinical staff to advance the dermatology research mission of the Department and the University. This role requires independent coordination of assigned studies, direct communication with investigators, sponsors, and CROs, and a strong commitment to participant safety, protocol compliance, and data quality. We are seeking a professional who thrives in a dynamic, team-based environment and is committed to advancing clinical research in dermatology. This position offers opportunities for professional growth, with structured training and increasing responsibility commensurate with experience, supporting progression within the Clinical Research Coordinator B/C career pathway. Job Description Job Responsibilities Clinical Research Coordinator B * Screen, recruit, consent, and enroll study participants as specified per protocol and GCP guidelines. * Schedule, prepare for, and conduct protocol-required participant visits and assessments. * Review clinic schedules and medical records to identify potentially eligible participants and support recruitment efforts. * Prepare and submit IRB documentation for initial submissions, continuing reviews, amendments, and adverse event reporting. * Coordinate, organize, complete, and maintain source documents, case report forms, regulatory documents, and participant binders in accordance with ALCOA-C standards. * Enter data into electronic data capture systems (e.g., REDCap, sponsor systems) and ensure data accuracy and completeness. * Perform data quality control and resolve data queries within required timelines. * Monitor participants per protocol requirements and document adverse events and protocol deviations as applicable. * Demonstrate vigilance in participant safety, protocol compliance, and data quality. * Adhere to all University of Pennsylvania policies and applicable FDA and GCP guidelines. * Effectively manage multiple clinical trials independently while supporting other coordinators as needed. * Demonstrate problem-solving skills by identifying challenges and escalating issues appropriately. * Develop, present, and implement participant recruitment strategies in collaboration with investigators and the research team. * Work closely with the Clinical Research Program Manager to support study start-up, activation, and ongoing trial operations. Clinical Research Coordinator C (In addition to the responsibilities outlined for CRC-B) * Work independently with minimal supervision and may serve in a lead coordinator role or act as back-up to the supervisor. * Independently coordinate complex investigator-initiated and industry-sponsored dermatology clinical trials, managing study timelines, workflows, and day-to-day execution. * Partner directly with faculty investigators to support study design, start-up, and implementation of investigator-initiated trials. * Provide guidance, training, or informal mentorship to less experienced coordinators and support coverage during staffing transitions. * Contribute to preparation of study reports, abstracts, manuscripts, or grant applications as requested by investigators. * Support budget-related activities and study feasibility discussions in collaboration with CSU leadership, as appropriate. Responsibilities/Duties * Lead participant screening by reviewing medical records and assessing eligibility criteria. Conduct informed consent discussions, ensure participant understanding, and maintain required documentation. Support recruitment through clinic schedule review, coordination with investigators and referring providers, and direct outreach to potential participants. * Coordinate all protocol-required visits, treatments, assessments, and follow-up appointments to ensure adherence to study timelines and procedures. Meet with the Principal Investigator to review participant status, required next steps, and address questions related to assessments, documentation, or clinical issues. Identify operational barriers and escalate items requiring medical or regulatory decision-making. * Monitor participants per protocol requirements, document adverse events and concomitant medications, and complete safety reporting in a timely and accurate manner. Report adverse events to the sponsor, IRB, and designated oversight groups in accordance with study and institutional requirements. * Prepare study start-up materials, including visit guides, source documentation tools, participant binders, e-regulatory binders, and required tracking logs. Assemble and submit documents to institutional committees (e.g., IRB, CTSRMC) to support study activation. Confirm workflow feasibility with clinic operations and ensure readiness prior to first enrollment. * Review clinical information from visits and assessments and enter required data into electronic data capture platforms with a focus on accuracy and completeness. Maintain organized source documentation, regulatory files, and enrollment logs to support monitoring, audit, and internal review. Ensure data entry, document updates, and data queries are addressed within study timelines. * Participate in study meetings, initiation sessions, and protocol training. Provide regular updates on enrollment progress, visit completion, safety reporting, and data status. Support operational consistency by identifying workflow needs and contributing to tools, guidance documents, or process improvements that enhance study execution. * Perform additional duties as assigned Qualifications Effective problem-solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task, demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations. Clinical Research Coordinator B: Bachelor's degree and 2-3 years of experience, or equivalent combination of education and experience, are required. The successful candidate must have: (1) practical experience coordinating the day-to-day activities of multiple research projects; (2) effective verbal and written communication skills; (3) ability to learn new methods quickly and multi-task; (4) demonstrated ability to work as part of a team as well as independently; (5) possess working knowledge of International Conference of Harmonisation (ICH) and Good Clinical Practice (GCP) Guidelines. Clinical Research Coordinator C: Bachelor's degree and 4-5 years of experience, or equivalent combination of education and experience, are required. The successful candidate must have: (1) practical experience coordinating the day-to-day activities of multiple therapeutic research protocols; (2) effective verbal and written communication skills; (3) ability to learn new methods quickly and multi-task; (4) demonstrated ability to work as part of a team as well as independently; (5) possess working knowledge of International Conference of Harmonisation (ICH) and Good Clinical Practice (GCP) Guidelines. This position is contingent upon funding. Job Location - City, State Philadelphia, Pennsylvania Department / School Perelman School of Medicine Pay Range $52,500.00 - $67,046.00 Annual Rate Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered. Equal Opportunity Statement The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics) , citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law . Special Requirements Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job. University Benefits * Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars. * Tuition : Take advantage of Penn's exceptional tuition benefits . You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions. * Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard. * Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family-whatever your personal needs may be. * Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting. * Wellness and Work-life Resources : Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance. * Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally. * University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitement-and you and your family can enjoy many of these activities for free. * Discounts and Special Services : From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks. * Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures. * Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements. * Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household. ? To learn more, please visit: The University of Pennsylvania's special character is reflected in the wide variety of backgrounds, experiences, and perspectives of the Penn community. We seek talented faculty and staff who will constitute a vibrant community and help create an educational and working environment that best supports the University's commitment to excellence in teaching, research, and scholarship. The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status, or any class protected under applicable federal, state or local law.

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