Clinical Trial Specialist

Job Title

Clinical Trial Specialist

We are seeking a dedicated Clinical Trial Specialist to join our team, focusing on protocol activation and study accrual. This role involves collaborating with various departments to initiate and activate new clinical trial protocols, ensuring compliance with regulatory requirements, and providing high-quality patient care. The successful candidate will facilitate communication between patients and research teams, manage protocol‑specific orders, and ensure adherence to study guidelines.

• Collaborate with the Protocol Activation office to initiate and activate new clinical trial protocols, utilizing study‐start up task lists.
• Prepare and review study tools, including study binders, medication diaries, eligibility checklists, and flow sheets.
• Verify Scientific Review Board (SRB), Institutional Review Board (IRB), data collection plans, and finance/contract approvals prior to study activation.
• Conduct protocol‑related nursing education to facilitate safe, effective care of enrolled patients.
• Translate finalized protocol treatment plans, study calendars, and clinical trials billing grids into sample orders.
• Coordinate with the clinical research team for timely prescreening of potential subjects and active cancer patients for available clinical trials.
• Review patient charts and medical history to confirm protocol eligibility and obtain source documents as needed.
• Ensure informed consent processes are followed, and consent is obtained, signed, and documented in medical records.
• Provide back‑up support for registering consented research patients with study sponsors and input data into the clinical trials database.
• Serve as a resource for Clinical Trial Billing Information related to assigned studies.
• Act as a link between patients and research team members, addressing and communicating challenges in protocol procedures.
• Ensure accurate execution of protocol‑specific orders, scheduling, and completion of tests and appointments.
• Coordinate protocol‑specified procedures and treatments for study patients across disciplines and sites of care.
• Manage patient reimbursement while on clinical trials using study‑specific methods.
• Deliver compassionate oncology nursing care and coordinate with clinical teams as per protocol requirements.
• Provide nursing assessments and documentation for protocol‑specified visits, ensuring reconciliation of concomitant medications.
• Drive collaboration with medical system staff to ensure timely service delivery to patients.
• Grade adverse events using protocol‑referenced criteria and document toxicities accurately.
• Complete Serious/Unexpected Adverse Event forms and ensure accurate completion of follow‑up reports.
• Assist with monitoring visits, audits, and provide timely responses to sponsor queries.
• Maintain research records for screened and enrolled patients, ensuring compliance with regulations and standards.
• Participate in training programs, workshops, and disease‑specific meetings to stay up‑to‑date on departmental objectives.
• Provide training and orientation to faculty and staff as needed.

• Three years of relevant clinical research experience.
• Bachelor’s Degree required.
• Solid knowledge of clinical research processes and oncology.
• Comfortable communicating with patients.
• Experience in pediatric oncology is preferred.

Our vision is to be a leader in scientific discovery, patient care, and education in cancer research. We conduct innovative research and cutting‑edge patient‑centered care to improve cancer outcomes. The clinical operations team consists of 40 FTEs across disease‑specific groups such as breast, lung, phase 1, and GI. We operate in Newark and 12 other sites, with a goal of enrolling 5,000 subjects per year in over 300 active trials across all phases, including both adult and pediatric studies.

This is a Contract to Hire position based out of Newark, NJ.

The pay range for this position is $33.00 - $38.00/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…