Clinical Research Coordinator - GI Oncology

The Gastrointestinal (GI) Oncology Clinical Research Program at Dana‑Farber Cancer Institute is seeking a Clinical Research Coordinator (CRC) to join our program. The GI Oncology Clinical Research Program supports PI‑initiated, industry‑sponsored, and cooperative group phase I–IV clinical trials across multiple GI cancers, including esophageal, stomach, liver, pancreas, colon, and neuroendocrine.

The Clinical Research Coordinator works within the clinical research program and supports the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator. The CRC will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical trials. They ensure timely collection of protocol‑related samples, including shipment to outside entities as required.

They maintain regulatory binders and ensure study compliance with all state, federal, and IRB requirements. They may also be responsible for IRB protocol submissions (amendments, continuing reviews, and minimal risk protocols). The CRC may also screen patients for protocol eligibility, obtain informed consent, and register study participants with the Quality Assurance Office for Clinical Trials (QACT). Some travel may be required.

Located in Boston and the surrounding communities, Dana‑Farber Cancer Institute is a leader in life‑changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high‑risk and underserved populations.

We conduct groundbreaking research that advances treatment, educate tomorrow's physicians/researchers, and work with amazing partners, including other Harvard Medical School‑affiliated hospitals.

• Oversight of the clinical trials start‑up process from receipt of protocols through the Scientific Review Committee and IRB submissions, and site activation activities.
• Responsible for data reporting and management, collection of source documents, use and development of case report forms, adverse events reporting, filing, and archiving of study records, and resolution of data queries.
• May prepare and/or complete regulatory related reports and IRB submissions. Maintain and organize study participant/subject trial binder and regulatory binders, enter all required study data on an ongoing basis and as applicable.
• Ensure all study related samples are collected, properly prepared, and shipped according to the protocol requirements and IATA/DOT regulations.
• Collaborate with other departments such as Protocol Scheduling, Materials Management, the Clinical Research Laboratory, Pharmacy, Research Nursing, and other departments, as needed per the requirements of the clinical trial.
• Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.
• Coordination and management of clinical trials throughout the trial life cycle, including communication with sponsors and regulatory authorities.
• Close‑out of clinical trials, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved.
• Interact with study participants as directed/required by the protocol and/or study team.
• May be responsible for tissue sample collection per trial requirements.
• Responsible for data entry of Subject Visit Tracking information into Clinical Trial Management System contemporaneously with medical visits, assessments, and other subject‑specific information.
• Responsible for data entry of time and effort spent on study‑specific activities and other administrative tasks into Clinical Trial Management System contemporaneously with work completed.
• Responsible for data entry of study‑specific activity, including but not limited to monitor visits, external site enrollment, amendments, receipt of Safety Reports, etc., into Clinical Trial…