Sr. Regulatory Coordinator / Radiation Oncology
Brigham & Women's Hospital(BWH)

The Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), and Clinical Research Manager to complete the regulatory requirements of the clinical research program at department of Radiation Oncology at BWH/DFCI. Serving 30+ physicians and assisting 17+ clinical research coordinators to fulfill the regulatory requirement of a departmental research portfolio consist of 80+ studies. The RC coordinates all aspects of protocol submissions, prepares and submits all regulatory documents, and maintains records on each study to ensure regulatory compliance with PHS, Harvard Catalyst, DFCI, and DF/HCC policies as well as federal and ICH/GCP guidelines. This position will work collaboratively with a variety of personnel at all levels, including faculty and study team members of DF/HCC and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. Works interactively with the Office for Human Research Studies (OHRS), Quality Assurance of Clinical Trials (QACT), and the Clinical Trials Education Office (CTEO), as well as Clinical Trials Offices at the various DF/HCC institutions.

• Serves as the regulatory point of contact for internal and external stakeholders and provides regulatory document management expertise to research teams in preparation of study start-up and closeout.
• Managing the regulatory aspect of the research portfolio at department of Radiation Oncology consist of more than 80 protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval.
• Prepares and submits regulatory documentation including IND/IDE applications, annual reports, Serious Adverse Event reports, etc. to the appropriate regulatory agencies including the U.S. Food and Drug Administration (FDA).
• Organizes and maintains regulatory documentation, including training documentation (i.e., HSP, GCP, protocol specific training documents) for each study.
• Maintains the Trial Master File (as appropriate) for multicenter and/or IND trials.
• Maintains various regulatory records and databases with information related to study recruitment, subject enrollment, and study completion.
• Provides regulatory guidance and assists with site preparation for audits (Regulatory Agency, Sponsor, etc.). Assist developing corrective action plans, as needed.
• Assists in the training of research coordinators in basic regulatory activities and provides ongoing educational support.
• Coordinates monitoring and auditing visits with QACT, Industry Sponsors, and third-party auditors.
• Interacts and communicates with Sponsors to ensure that regulatory compliance of all studies is maintained.
• Other duties as assigned.

Qualifications
Regulatory Coordinator

Bachelor's degree (BA, BS) in life sciences, nursing, or other health related discipline is required. Minimum 1-2 years of related research experience or research specific training required. Masters in Regulatory Affairs will be considered a substitute for years of experience. Knowledge of FDA, ICH/GCP guidelines, and/or experience in the conduct of clinical trials is preferred. Certified Clinical Research Professionals (CCRP®s) is preferred.

Sr. Regulatory Coordinator

Bachelor's degree (BA, BS) in life sciences, nursing, or other health related discipline is required; Master's or other advanced degree highly preferred. Minimum 3-5 years of direct regulatory experience required. Must have current knowledge of FDA and ICH/GCP guidelines. Previous experience with clinical trials and/or research coordination highly desirable. Certified Clinical Research Professionals (CCRP®s) is preferred.

EEO Statement
Brigham and Women's Hospital is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, national origin, sexual orientation, protected veteran status, or on basis of disability.

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