The Clinical Trial Specialist coordinates and supports all aspects of clinical research studies from initiation through activation and ongoing conduct. This role focuses on ensuring regulatory readiness, maintaining high-quality research documentation, supporting investigators and research nurses, and safeguarding patient safety and data integrity in a busy oncology-focused clinical trials program.Responsibilities
- Coordinate the initiation and activation of new clinical trial protocols by verifying Scientific Review Board, Institutional Review Board, Human Research Oversight Committee approvals, data collection plans, and finance/contract approvals prior to study activation.
- Prepare and organize study tools, including study binders, medication diaries, eligibility checklists, calendars, and flow sheets, ensuring they are complete, accurate, and ready for use before patient enrollment.
- Use clinical trial management systems and Microsoft Excel and Word to develop and maintain study tools and documentation that support protocol compliance and efficient trial conduct.
- Collaborate with Research Nurse Clinicians and physicians to review patient charts and medical histories, confirm protocol eligibility, and obtain required source documents such as medical record documentation.
- Under the direction of the Research Nurse Clinician and/or physician, ensure that IRB-approved informed consent forms are properly obtained, signed, filed in the medical record, and that copies are provided to patients.
- Register consented research participants with study sponsors, including industry sponsors and cooperative groups, and enter required data into the clinical trials database.
- Maintain complete and accurate research records for all patients enrolled on clinical trials, including patient consent, eligibility documentation, case report forms, registration confirmations, and corresponding source documents across centers, community physician offices, and hospitals.
- Assist, in collaboration with the Research Nurse Clinician and physician, in grading adverse events using the most recent National Cancer Institute common toxicity criteria or protocol-specific grading scales.
- Complete Serious and Unexpected Adverse Event forms for internal and multicenter events in accordance with study sponsor requirements, federal regulations, and institutional guidelines.
- Ensure that research records remain current and audit-ready for all assigned trials, including those conducted at multiple sites and within disease-specific groups.
- Generate regular reports from the clinical trials database for tumor study group members and Principal Investigators, summarizing enrollment, status, and key metrics for assigned studies.
- Serve as a primary liaison with study sponsors, schedule monitoring visits and conference calls, and provide accurate, timely, and well-reasoned responses to sponsor queries.
- Support and monitor study conduct to ensure investigators and staff follow the treatment plan, Good Clinical Practice guidelines, and institutional policies.
- Participate in patient screening and study coordination activities, including recruitment, enrollment, and ongoing follow-up, while maintaining clear communication with patients throughout their participation.
- Communicate effectively and empathetically with patients to explain study procedures, answer questions, and support adherence to study requirements.
- Work closely with newly hired principal investigators and research team members to support their learning and engagement in clinical research processes.
Essential Skills
- Bachelors degree required.
- One to three years of relevant clinical research experience, preferably in a Clinical Research Coordinator or similar role.
- Experience in clinical research with exposure to oncology trials and clinical trial coordination.
- Demonstrated experience with patient screening, recruitment, enrollment, and coordination of study visits and procedures.
- Experience obtaining, handling, and maintaining source documents and research records in compliance with protocol and regulatory requirements.
- Solid knowledge and regular use of computer software programs such as Microsoft Excel and Word, and familiarity with clinical trial databases or clinical trial management systems.
Job Type & LocationThis is a Contract position based out of New Brunswick, NJ. Pay and BenefitsThe pay range for this position is $35.00 - $38.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.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) Job Type & LocationThis is a Contract position based out of New Brunswick, NJ. Application DeadlineThis position is anticipated to close on Nov 23, 2026. Workplace TypeThis is a fully onsite position in New Brunswick,NJ.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.
