Clinical Research Coordinator, GI Oncology

About the Role

The Gastrointestinal (GI) Oncology Clinical Research Program at Dana-Farber Cancer Institute is seeking a Clinical Research Coordinator (CRC) to support PI-initiated, industry-sponsored, and cooperative group phase I - IV clinical trials across multiple GI cancers. The CRC will work within the research program to support the research team in the overall conduct of clinical trials using Good Clinical Practice under the auspices of the Principal Investigator.

Key Responsibilities

• Primary data collection and management of patient clinical information for trial participation.
• Ensuring timely collection and shipment of protocol-related samples.
• Maintaining regulatory binders and ensuring study compliance with state, federal, and IRB requirements.
• May be responsible for IRB protocol submissions (amendments, continuing reviews, and minimal risk protocols).
• May screen patients for protocol eligibility, obtain informed consent, and register study participants.
• 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 binders 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 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 trial requirements.
• 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.
• May distribute protocol schedules, quality of life surveys or other study-related questionnaires, subject diaries, and/or conduct follow-up communication with patients.

Requirements & Tech Stack

• Good Clinical Practice
• IRB protocol submissions
• IATA/DOT regulations
• Clinical Trial Management System
• Microsoft Office

Qualifications

• Bachelor’s Degree or 1 year of Dana-Farber Associate Clinical Research Coordinator experience required.
• 0-1 years of experience working in a medical or scientific research setting or comparable technology-oriented business environment preferred.
• Excellent organization and communication skills required.
• Strong interpersonal skills – ability to effectively interact with all levels of staff and external contacts.
• Must be detail-oriented and have the ability to follow-through.
• Ability to effectively manage time and prioritize workload.
• Must practice discretion and adhere to hospital confidentiality guidelines at all times.
• May have contact with Adult and Pediatric patients of all ages and populations.
• Some travel may be required.