Clinical Trial Specialist

Clinical Trial Specialist

This role offers the opportunity to contribute to advanced, comprehensive cancer care for adults and children while supporting cutting-edge oncology clinical research. As a Clinical Trial Specialist, you help transform scientific discoveries into clinical practice by coordinating and managing cancer clinical trials, ensuring that studies are conducted in accordance with protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. You work closely with research nurses, physicians, sponsors, and patients to support the full lifecycle of oncology and hematology clinical trials, including pharmaceutical drug studies.

• Coordinate the initiation and activation of new clinical trial protocols, ensuring all required approvals and plans are in place before study activation, including Scientific Review Board (SRB), Institutional Review Board (IRB), Human Research Oversight Committee (HROC), data collection plans, and finance/contract approvals.
• Prepare and organize study tools and documentation, including study binders, medication diaries, eligibility checklists, calendars, and flow sheets, to support accurate and efficient study conduct.
• Use clinical trial databases and standard office software such as Excel and Word to develop and maintain study tools and trackers, ensuring information is current, accurate, and easily accessible.
• Collaborate with the Research Nurse Clinician (RNC) and physicians to review patients' charts and medical histories, confirm protocol eligibility, and obtain necessary source documents and medical record documentation.
• Under the direction of the RNC and/or physician, ensure that IRB-approved informed consent forms are properly obtained, signed, documented in the medical record, and provided to patients in accordance with regulatory and institutional requirements.
• Register consented research participants with study sponsors, including industry sponsors and National Cancer Institute (NCI) cooperative groups, and accurately enter data into the clinical trials database.
• Maintain complete and organized research records for all patients enrolled in clinical trials, including patient consent, eligibility documentation, case report forms (CRFs), registration confirmations, and corresponding source documents, across multiple centers, community physician offices, and hospitals.
• Assist the RNC and physicians in grading adverse events using the most recent NCI common toxicity criteria or protocol-specific grading scales, ensuring consistency and accuracy in safety reporting.
• Complete Serious/Unexpected Adverse Event (SAE) forms for internal and multicenter studies in accordance with study sponsor requirements, federal regulations, and institutional guidelines.
• Provide regular, data-driven reports to tumor study group members and Principal Investigators on assigned studies using the clinical trials database, highlighting enrollment, status, and key metrics.
• Serve as a primary liaison with study sponsors by scheduling monitoring visits and conference calls, anticipating sponsor needs, and delivering accurate, timely, and thoughtful responses to sponsor queries.
• Work in collaboration with the RNC and investigators to ensure that all study personnel conduct the trial according to the approved treatment plan, protocol specifications, and GCP guidelines.
• Support recruitment, screening, enrolling, and consenting of patients for oncology clinical research studies, ensuring that eligibility criteria are met and that patients are fully informed.
• Contribute to high-volume enrollment efforts across multiple disease-specific groups and sites, helping to meet ambitious subject enrollment and active trial goals.

• Bachelor's degree required.
• One to four years of relevant clinical research experience, preferably as a Clinical Research Coordinator or in a similar role.
• Demonstrated experience in recruitment, screening, enrolling, and consenting of patients for clinical research studies.
• Experience with oncology clinical research studies, including familiarity with cancer protocols and patient populations.
• Experience with pharmaceutical drug…