Clinical Trial Specialist

Clinical Trial Specialist

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 Board 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 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.

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.

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…