Dana-Farber Cancer Institute
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.
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. 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 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.
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/IDE applications, annual reports, Serious Adverse Event reports, 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.
Must possess excellent written and oral communication skills, maintain confidentiality of information, demonstrate good decision-making and judgment and have attention to detail and follow-through skills. Demonstrated organization and time management/prioritization skills with the ability to work independently are required. Must be proficient in the use of computers, Microsoft applications and databases. Requires experience with medical terminology.
Bachelor's degree (BA, BS) in life sciences, nursing, or other health related discipline is required. 1-2 years of related research experience or research specific training. 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.
M-F 40 hours