Clinical Trial Specialist

Job Title: Clinical Trial Specialist Job Description
The Clinical Trial Specialist coordinates and supports all aspects of clinical research studies from initiation through activation and ongoing conduct. This role ensures that protocols meet regulatory and institutional requirements, that participants are properly consented and registered, and that research records are accurate, complete, and audit-ready. The specialist works closely with research nurses, investigators, and study sponsors to maintain compliance with Good Clinical Practice (GCP) guidelines and to advance a broad portfolio of oncology clinical trials.
Responsibilities
- Coordinate the initiation and activation of new clinical trial protocols, ensuring all required approvals are in place prior to study activation, including Scientific Review Board, Institutional Review Board, Human Research Oversight Committee, data collection plans, and finance/contract approvals.
- Prepare and organize study tools such as study binders, medication diaries, eligibility checklists, calendars, and flow sheets, tailoring them to the specific requirements of each protocol.
- Use clinical trial management systems and Microsoft Excel and Word to develop and maintain study tools, tracking documents, and reports to support efficient study conduct.
- In collaboration with the Research Nurse Clinician and/or physician, review patient charts and medical histories to confirm protocol eligibility and obtain all necessary source documents from the medical record.
- Under the direction of the Research Nurse Clinician and/or physician, ensure that Institutional Review Boardapproved 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 all required information 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 supporting source documents across multiple centers, community practices, and hospitals.
- Assist, in collaboration with the Research Nurse Clinician and physician, with 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, organized, and compliant for all assigned patients, supporting monitoring visits, audits, and regulatory inspections.
- Use the clinical trials database to generate regular reports for tumor study group members and Principal Investigators on the status of assigned studies and enrolled participants.
- Serve as a primary liaison with study sponsors, anticipate sponsor needs, schedule monitoring visits and conference calls, and provide accurate, timely, and well-reasoned responses to sponsor queries.
- Work with the Research Nurse Clinician to ensure that investigators and all participating personnel conduct studies according to the protocol treatment plan and Good Clinical Practice guidelines.
- Support screening, recruitment, and enrollment of patients to clinical trials, including coordinating study visits and procedures in accordance with protocol requirements.
- Communicate clearly and professionally with patients, families, and clinical teams to explain study procedures, answer questions, and facilitate a positive research experience.
- Contribute to high enrollment targets across a large portfolio of active trials by efficiently coordinating study activities and helping to identify eligible participants.
Essential Skills
- One to three years of relevant clinical research experience, preferably in a clinical research coordinator or similar role.
- Experience coordinating clinical research studies, including patient screening, enrollment, and study visit coordination.
- Demonstrated experience working with informed consent processes and documentation in a clinical research setting.
- Ability to work confidently with source documents and medical records to verify protocol eligibility and support data collection.
- Solid knowledge of computer software programs such as Microsoft Excel, Word, and Access.
- Comfort and professionalism communicating directly with patients in a clinical or research environment.
- Strong attention to detail with the ability to maintain accurate, complete, and organized research records.
- Excellent organizational skills with the ability to manage multiple studies and tasks simultaneously.
- Clear written and verbal communication skills to interact effectively with investigators, research nurses, sponsors, and other stakeholders.
- Strong interpersonal skills to collaborate with multidisciplinary clinical and research teams.
- Ability to follow Good Clinical Practice guidelines and institutional policies in day-to-day study conduct.
Additional Skills & Qualifications
- Bachelors degree required.
- Three or more years of clinical research coordinator experience in oncology is highly beneficial.
- Prior experience in oncology clinical trials, including exposure to adverse event grading and NCI toxicity criteria, is a strong plus.
- Familiarity with clinical trial management systems and electronic databases for subject tracking and reporting.
- Demonstrated ability to hold oneself accountable to high standards of professional excellence and integrity.
- Proven ability to maximize available resources, work resourcefully, and adapt to changing priorities in a high-volume research environment.
- Commitment to ongoing personal and professional development and to staying current with clinical research best practices.
- Strong problem-solving skills and the ability to anticipate and address operational or data-related issues proactively.
Work Environment
This role operates within a large, highly specialized clinical operations and research environment focused on oncology, encompassing disease-specific groups such as breast, lung, phase I, and gastrointestinal studies. The broader research infrastructure includes regulatory affairs, quality assurance, informatics, education, and finance teams, supporting approximately 100 full-time employees. The site manages a robust clinical trial portfolio with around 300 active trials and approximately 1,000 active subjects, with a long-term goal of 2,500 active participants and roughly 5,000 subjects enrolled per year. Studies span all phases and include both adult and pediatric populations. The position supports activity at a major urban campus and multiple satellite sites across the state, requiring coordination across different clinics and hospitals. The work setting is fast-paced and highly collaborative, with significant enrollment demands and frequent interaction with investigators, research nurses, sponsors, and patients. Professional, clinical-appropriate attire is expected, and work is typically conducted during standard business hours, with occasional flexibility needed to meet protocol or sponsor requirements.
Job Type & Location
This is a Contract position based out of New Brunswick, NJ.
Pay and Benefits
The 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 & Location
This is a Contract position based out of New Brunswick, NJ.
Application Deadline
This position is anticipated to close on Nov 16, 2026.
Workplace Type
This 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.

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