Clinical Research Coordinator - GI Oncology

About the role

The Gastrointestinal (GI) Oncology Clinical Research Program at Dana-Farber Cancer Institute 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 (CRC) will work within the 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.

Responsibilities

• Primary data collection and management of patient clinical information as it pertains to participation in clinical trials.
• Ensure timely collection of protocol-related samples, including shipment to outside entities as required.
• Maintain regulatory binders and ensure study compliance with all state, federal, and IRB requirements.
• May be responsible for 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).
• Oversee 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.
• 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.
• 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 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.
• Data entry of Subject Visit Tracking information into the Clinical Trial Management System contemporaneously with medical visits, assessments, and other subject-specific information.
• Data entry of time and effort spent on study-specific activities and other administrative tasks into the Clinical Trial Management System contemporaneously with work completed.
• Data entry of study-specific activity, including but not limited to monitor visits, external site enrollment, amendments, receipt of Safety Reports, etc., into the Clinical Trial Management System contemporaneously with activity completed.

Requirements

• 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.

Skills

• Excellent organization and communication skills.
• Strong interpersonal skills – ability to effectively interact with all levels of staff and external contacts.
• Detail-oriented with 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.
• Computer skills including the use of Microsoft Office.

Patient Contact

• May have contact with adult and pediatric patients of all ages and populations.
• May distribute protocol schedules, quality of life surveys or other study-related questionnaires, subject diaries, and/or conduct follow-up communication with patients.

Pay

$48,100.00 - $54,400.00