Clinical Trial Specialist
hace 4 días
Newark
Job Description Job Title: Clinical Trial Specialist Job Description This role offers the opportunity to contribute to a leading National Cancer Institute–designated Comprehensive Cancer Center that delivers advanced cancer care to adults and children while conducting cutting-edge oncology research. The Clinical Trial Specialist supports the activation and coordination of complex oncology clinical trials, helping translate research discoveries into clinical practice and advancing cancer prevention, detection, and treatment through high-quality clinical research operations. Responsibilities • Coordinate the initiation and activation of new clinical trial protocols, ensuring all required approvals and documentation are in place prior to study activation., • Verify Scientific Review Board, Institutional Review Board, Human Research Oversight Committee approvals, data collection plans, and finance/contract approvals before opening a study to enrollment., • Prepare and organize study tools such as study binders, medication diaries, eligibility checklists, calendars, and flow sheets to support accurate and compliant trial conduct., • Use clinical trials software and Microsoft Excel and Word to develop, maintain, and update study tools and tracking documents., • Collaborate with Research Nurse Clinicians and physicians to review patient charts and medical histories, confirm protocol eligibility, and obtain required source documents from the medical record., • Ensure that IRB-approved informed consent is obtained in accordance with regulatory and institutional requirements, including confirming signatures, filing consent forms in the medical record, and providing copies to patients., • Register consented research participants with study sponsors, including industry partners and NCI cooperative groups, and enter participant data into the clinical trials database., • Maintain complete and accurate research records for all patients enrolled on clinical trials, including consent forms, eligibility documentation, case report forms, registration confirmations, and corresponding source documents., • Support research activities across multiple locations, including main centers, investigator-initiated trials, community physician offices, and affiliated hospitals, ensuring consistency and compliance in documentation., • Assist Research Nurse Clinicians and physicians in grading adverse events using the latest National Cancer Institute common toxicity criteria or protocol-specific grading scales., • Complete Serious/Unexpected Adverse Event forms for internal and multicenter events in accordance with sponsor requirements, federal regulations, and institutional policies., • Monitor research records regularly to ensure they remain current, accurate, and audit-ready for all assigned clinical trials., • Generate regular reports from the clinical trials database for tumor study group members and Principal Investigators, summarizing enrollment, status, and key trial metrics., • Serve as a primary liaison with study sponsors, coordinating monitoring visits, conference calls, and ongoing communications throughout the life of each study., • Provide timely, accurate, and well-supported responses to sponsor queries and anticipate sponsor needs to maintain strong collaborative relationships., • Work with Research Nurse Clinicians and investigators to ensure that all personnel conduct studies in accordance with approved treatment plans, institutional policies, and Good Clinical Practice guidelines., • Participate in the recruitment, screening, enrollment, and consenting of patients for oncology clinical research studies, ensuring a positive and informative experience for participants., • Coordinate day-to-day study operations, including scheduling study visits, tracking required assessments, and ensuring adherence to protocol timelines., • Communicate effectively with patients, clinical teams, and research staff to clarify procedures, explain study requirements, and support participant engagement and retention., • Contribute to continuous improvement of clinical research processes by maintaining high professional standards, maximizing available resources, and supporting quality assurance activities. Essential Skills • Bachelor’s degree required., • Two to four years of relevant clinical research experience, preferably in oncology., • Experience as a Clinical Research Coordinator or in a closely related clinical research role., • Demonstrated experience in recruitment, screening, enrollment, and consenting of patients for clinical research studies., • Hands-on experience with oncology clinical research studies and pharmaceutical drug trials., • Solid knowledge of computer software programs, including Microsoft Excel, Word, and Access., • Experience using clinical trials databases and electronic health record systems such as Epic., • Strong understanding of informed consent processes, source documentation requirements, and regulatory expectations in clinical research., • Comfort communicating with patients, clinicians, and research teams about study procedures, consent, and documentation., • Ability to interpret and apply National Cancer Institute common toxicity criteria or protocol-specific adverse event grading scales., • Excellent attention to detail and accuracy in documentation and data entry., • Strong organizational skills with the ability to manage multiple trials, tasks, and timelines simultaneously., • Effective written and verbal communication skills for interacting with patients, investigators, sponsors, and internal teams., • Ability to work collaboratively in a multidisciplinary environment and support Good Clinical Practice standards. Additional Skills & Qualifications • One to three years of clinical research experience considered with strong demonstrated competencies; two to four years is preferred., • Prior experience coordinating oncology clinical research trials across multiple phases., • Experience working with NCI cooperative group studies and industry-sponsored pharmaceutical trials., • Familiarity with tumor-specific study groups such as breast, lung, gastrointestinal, and early-phase trials., • Experience supporting both adult and pediatric clinical trial populations., • Exposure to large, multi-site clinical research programs with high enrollment volumes., • Proven ability to produce clear, well-organized study tools, including eligibility checklists, diaries, calendars, and flow sheets., • Demonstrated ability to respond promptly and accurately to sponsor queries and to prepare for monitoring visits., • Track record of holding oneself accountable to high standards of professional excellence and ethical conduct., • Resourceful and proactive approach to problem-solving, with the ability to maximize available resources., • Commitment to ongoing personal and professional development and willingness to accept responsibility for continuous improvement. Work Environment The role is based within a large, comprehensive clinical operations structure that includes disease-specific groups such as breast, lung, phase I, and gastrointestinal oncology, as well as dedicated teams in regulatory affairs, quality assurance, informatics, education, and finance. The program currently supports approximately 100 full-time research staff and enrolls around 5,000 subjects per year across Newark and multiple additional sites throughout the state. The environment features approximately 300 active clinical trials and about 1,000 active subjects, with a long-term goal of increasing to 2,500 active participants. Trials span all phases and include both adult and pediatric studies, providing exposure to a broad range of cancer indications and treatment modalities. Clinical Trial Specialists work closely with multidisciplinary clinical and research teams, leveraging electronic health records such as Epic and specialized clinical trial management systems, as well as standard productivity tools like Microsoft Excel, Word, and Access. The setting is fast-paced and highly collaborative, with significant enrollment needs and a strong focus on quality, compliance, and patient-centered care. Attire is professional to align with clinical and research interactions in hospital and clinic environments. Job Type & Location This is a Contract position based out of Newark, NJ. Pay and Benefits The pay range for this position is $32.00 - $37.00/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 fully onsite position in Newark,NJ. Application Deadline This position is anticipated to close on Aug 4, 2026. 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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. 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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options. San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records. Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.
