Clinical Research Coordinator - Dana Farber

This position within the Division of Cancer Genetics and Prevention in collaboration with faculty investigators and the research team will support the research team in the overall conduct of national/and or institutional projects related to cancer prevention, early identification of individuals at high risk for cancer, and biorepository collections, using Good Clinical Practice under the auspices of the Principal Investigator(s) and the DFCI Clinical Trials Office. The Clinical Research Coordinator (CRC) will be responsible for the primary data collection and management of patient clinical information as it pertains to participation in clinical studies, ensures the timely collection and management of protocol-related samples, maintains regulatory binders, and ensures study compliance with state, federal, and IRB requirements. The CRC may be responsible for IRB protocol submissions (including amendments, continuing reviews, and minimal risk protocols), screening patients for protocol eligibility, obtaining informed consent and related participant registration.

• Oversight of research study 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 such as amendments and continuing reviews. Maintain and organize study regulatory binders and 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 studies, including communication with sponsors and regulatory authorities.
• Close-out of studies, including contributing to research articles, audit preparation, and communication with regulatory agencies and other disciplines involved.
• Screening participants for protocol eligibility, obtaining informed consent, participant recruitment, registering study participants, data collection, and adverse events reporting.
• Interact with study participants as directed/required by the protocol and/or study team.

• Bachelor’s degree required, with 0-1 years of related experience preferred
• Excellent organization and communication skills required. Strong interpersonal skills: ability to effectively interact with all levels of staff and external contacts. Must be detail oriented and have the ability to follow through. Ability to effectively manage time and prioritize workload. Must practice discretion and always adhere to hospital confidentiality guidelines. Must have computer skills including the use of Microsoft Office.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• Strong attention to detail, organizational, communication and interpersonal skills.
• Excellent ability to work independently and balance multiple projects and tasks simultaneously.
• Ability to work as a member of a team and proactively lead teams.

SUPERVISORY RESPONSIBILITIES: N/A

PATIENT CONTACT: Will have contact with patients of all ages and populations.

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 groups as protected by law.

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