Sr Regulatory Coordinator
Dana-Farber Cancer Institute
Boston
Job Description
Job ID: 22660Date Posted: 06/20/2012
Location: Galleria
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.
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 pro gram. 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 DFIHCC policies as well as federal and ICH/GCP guidelines,
This position will work collaborative1y with a variety of persormel at all levels, including
faculty and study team members of DF/HCC and extemal 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 Cliuical Trials Offices at the various DFIHCC
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 docwnentation including INDIIDE applications,
armual 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 andlor IND trials.
• Maintains various regulatory records and databases with information related to study
recruitment, subject enrollment, and study completion.
• Coordinates monitoring and auditmg visits with QACT, Industry Sponsots, and third
party auditors.
• Interacts and communicates with Sponsors to ensure that regulatory compliance of 'all
studies is maintained.
Job Qualifications:
Bachelor's degree (BA, BS) in life sciences, nursing, or other health related discipliue is required;
Master's or other advanced degree highly preferred. 3-5 years of direct regulatory experience
required. Must have current knowledge of FDA and ICHlGCl' guidelines. Previous experience
with clinical trials and/or research coordination highly desirable.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
Must possess excellent written and oral co=unication 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 jndependently are required. Must be proficient in the use of computers,
Microsoft applications and databases, Requires experience with medical tenninology
Schedule:
Full time, 8-4:40
Employment Type
Full-Time
