Clinical Research Coordinator - Thoracic Oncology

Overview

The CRC (Clinical Research Coordinators) work within the Thoracic Oncology 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.

They ensure timely facilitation of trial assessments per protocol and collection of protocol-related samples, including shipment to outside entities as required. The CRC may support and maintain participant/subject trial binders and regulatory binders to ensure study compliance with state, federal, and IRB requirements. They may be responsible for pertinent IRB protocol submissions, screen patients for protocol eligibility, obtain informed consent for non-treatment trials, and register study participants with the clinical trials management system ONCORE.

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.
• 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 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 (e.g., Protocol Scheduling, Materials Management, Clinical Research Laboratory, Pharmacy, Research Nursing) as needed per the trial requirements.
• Organize and prepare for 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, contribute 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 and assessments.
• Data entry of time and effort spent on study-specific activities and other administrative tasks into the CTMS contemporaneously with work completed.
• Data entry of study-specific activity (e.g., monitor visits, external site enrollment, amendments, receipt of Safety Reports) into the CTMS contemporaneously with activity completed.

• Excellent organization and communications skills.
• Strong interpersonal skills with the ability to interact effectively with all levels of staff and external contacts.
• Attention to detail and 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 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.

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, and conduct groundbreaking research that advances treatment.

We educate tomorrow's physician/researchers and work with partners, including other Harvard Medical School-affiliated hospitals.

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…