Regulatory Coordinator:  Breast Oncology Center (BOC)

Dana-Farber Cancer Institute
Boston

Job Description

Job ID: 22882
Date Posted: 08/29/2012
Location: Yawkey Center for Cancer Care
Job Family: Research
Full/Part Time: Full-Time
Regular/Temporary: Regular
FLSA Status: Exempt

Job Summary

Located in Boston, Dana Farber Cancer Institute brings together world renowned clinicians, innovative researchers and dedicated professionals, allies in the common mission of conquering cancer, HIV/AIDS and related diseases. Combining extremely talented people with the best technologies in a genuinely positive environment, we provide compassionate and comprehensive care to patients of all ages; we conduct research that advances treatment; we educate tomorrow’s physician/researchers; we reach out to underserved members of our community; and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

Dana-Farber Cancer Institute is an Affirmation Action/Equal Opportunity Employer - committed to diversity and inclusion in our workforce.

The Division of Women's Cancers Breast Oncology Center (BOC) is currently recruiting for a Regulatory Coordinator (RC). The Regulatory Coordinator (RC) works under the direction of the Principal Investigators(s), and Clinical Research Manager to complete the regulatory requirements of the clinical research program. The RC coordinates all aspects of protocol submissions, prepares and submits all regulatory documents, and maintains records of each study to ensure regulatory compliance with 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 Subjects (OHRS), Quality Assurance for Clinical Trials (QACT), and the Clinical Trials Education Office (CTEO), as well as Clinical Trials Office at the various DF/HCC institutions.

Primary Duties and Responsibilities:

• Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval.
• Prepares and submits regulatory documentation including IND applications, annual reports, serious adverse event reporting, etc. to the appropriate regulatory agencies including the U.S. Food and Drug Administration (FDA).
• Maintains and organizes regulatory documentation for each study (site regulatory binders).
• 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.
• 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.