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. The coordinator ensures timely collection of protocol‑related samples, shipment to outside entities as required, maintains regulatory binders, and ensures study compliance with all state, federal, and IRB requirements.

The CRC may also handle IRB protocol submissions (amendments, continuing reviews, and minimal‑risk protocols), 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.

• 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 Management System contemporaneously with activity completed.

• Excellent organization and communication skills.
• Strong interpersonal skills – ability to effectively interact with all levels of staff and external contacts.
• Detail oriented and able to follow through.
• Ability to effectively manage time and prioritize workload.
• Adhere to hospital confidentiality guidelines at all times.
• Computer skills including the use of Microsoft Office.

• Bachelor’s Degree or 1 year of Dana‑Farber Associate Clinical Research Coordinator experience required. 0–1 year of experience working in a medical or scientific research setting or comparable…