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The Clinical Research Coordinator (CRC) works within the clinical research program to support the research team in the conduct of clinical trials in accordance with Good Clinical Practice (GCP) under the guidance of the Principal Investigator (PI). The CRC is responsible for the primary collection and management of patient clinical data related to trial participation. Key responsibilities include ensuring the timely collection and shipment of protocol-required samples, maintaining regulatory binders, and ensuring compliance with all institutional, state, and federal regulations, including IRB requirements.

The CRC may also be responsible for submitting IRB-related documents such as amendments, continuing reviews, and minimal risk protocols. Additional duties may include screening patients for eligibility, obtaining informed consent, and registering participants with the Quality Assurance Office for Clinical Trials (QACT). Some travel may be required. Our work includes pioneering research to advance treatment, educating the next generation of physician-scientists, and collaborating with exceptional partners, including other Harvard Medical School-affiliated hospitals.

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 are united in our mission to conquer cancer, HIV/AIDS, and related diseases. We are committed to fostering an inclusive, diverse, and equitable environment where we provide compassionate, comprehensive care to patients of all backgrounds. We also develop programs to promote public health, particularly among high-risk and underserved populations.

+ 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 regulatory binders, enter all required study data on an ongoing basis.

+ Ensure all study related samples are collected, properly prepared and shipped according to the protocol requirements and IATA/DOT regulations.

+ Responsible for organizing and preparing for both internal and external auditing and study monitoring visits.

+ Coordination and management of clinical trials, 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 work.

+ Bachelor's Degree required.

+ 0-1 years of related experience preferred.

+ Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

+ Excellent organization and communications skills required.

+ Strong interpersonal skills – ability to effectively interact with all levels of staff and externals 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.

+ Must have computer skills including the use of Microsoft Office.

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. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply.

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.

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