Clinical Research Coordinator - Cancer Hematology

Overview

The CRC (Clinical Research Coordinators) 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 and the Clinical Research Manager. The CRC is responsible for primary data collection and management of patient clinical information related to participation in clinical trials. This includes ensuring timely facilitation of trial assessments per protocol, collecting protocol-related samples (including shipment to outside entities as required), and supporting and maintaining participant/subject trial binders and regulatory binders to ensure study compliance with state, federal, and IRB requirements.

The CRC may be responsible for pertinent IRB protocol submissions. This role may screen patients for protocol eligibility, obtain informed consent for non-treatment trials, and register study participants with the Clinical Trial Management System, ONCORE. Some travel to Dana-Farber Cancer Institute (DFCI) satellite sites 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 strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds. We design programs to promote public health, particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment and education for physician/researchers, and we work with 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.
• 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.
• 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 data into the Clinical Trial Management System contemporaneously with medical visits, assessments, and other subject-specific information.
• Enter time and effort spent on study-specific activities and other administrative tasks into the Clinical Trial Management System contemporaneously with work completed.
• Enter data for study-specific activity (e.g., monitor visits, external site enrollment, amendments, receipt of Safety Reports) into the Clinical Trial Management System contemporaneously with activity completed.

• Excellent organizational and communication skills.
• Strong interpersonal skills with 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.
• Discretion and adherence 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 years of experience in a medical or scientific research setting or comparable technology-oriented business environment preferred.

None

All positions:
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.

At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. We are committed to having faculty and staff who offer multifaceted…