Clinical Research Coordinator - GU Oncology

Clinical Research Coordinator - GU Oncology

The Clinical Research Coordinator (CRC) will work within the Genitourinary Oncology (GU) clinical research program and support 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, ensuring timely collection of protocol‑related samples, maintaining regulatory binders, and ensuring compliance with all state, federal, and IRB requirements.

The CRC may also screen patients for protocol eligibility, obtain informed consent, and register study participants. 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. The Institute is committed to an inclusive, diverse, and equitable environment that provides compassionate and comprehensive care to patients of all backgrounds. It also promotes public health, especially among high‑risk and underserved populations, through groundbreaking research and education.

• Oversee the clinical trials start‑up process from receipt of protocols through 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 event 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, entering all required study data on an ongoing basis.
• Ensure all study‑related samples are collected, properly prepared, and shipped according to protocol requirements and IATA/DOT regulations.
• Collaborate with departments such as Protocol Scheduling, Materials Management, Clinical Research Laboratory, Pharmacy, Research Nursing, and others as needed per the requirements of the clinical trial.
• Organize and prepare for both internal and external auditing and study monitoring visits.
• Coordinate and manage 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.
• Enter Subject Visit Tracking information and time/effort data into the Clinical Trial Management System contemporaneously with medical visits, assessments, and other subject‑specific information.
• Enter study‑specific activities such as monitor visits, external site enrollment, amendments, and receipt of Safety Reports into the Clinical Trial Management System contemporaneously with activity completion.

• Excellent organization and communication skills.
• Strong interpersonal skills – ability to interact effectively with all levels of staff and external contacts.
• Detail oriented with the ability to follow through.
• Ability to manage time and prioritize workload.
• Practice discretion and adhere to hospital confidentiality guidelines at all times.
• Computer skills, including 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 technology‑oriented business environment preferred.

Supervisory Responsibilities:

None

Patient Contact:
May interact with adult and pediatric patients of all ages and populations; may distribute protocol schedules, quality‑of‑life surveys, study‑related questionnaires, subject diaries, and/or conduct follow‑up communication with patients.

Pay: $48,100.00 - $54,400.00

Dana‑Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.