Sr Regulatory Coordinator

Job Description

Job ID: 21605
Date Posted: 09/06/2011
Location: 44 Binney St, Boston
Job Family: Research
Full/Part Time: Full-Time
Regular/Temporary: Regular
FLSA Status: Exempt

Job Summary:

The Division of Women's Cancers-- Breast Oncology Center is currently recruiting a Senior Regulatory Coordinator to support to the Clinical Research Program. The Senior Regulatory Coordinator (Sr. 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 Sr. 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/IDE 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.

Job Qualifications:

Bachelors degree (BA, BS) in life sciences, nursing, or other health related discipline is required; Masters or other advanced degree highly preferred. 3-5 years direct experience required. Must have current knowledge of FDA and ICH/GCP guidelines. Previous experience with clinical trials and/or research coordination highly desirable.

Must possess excellent written and oral communications 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.

Schedule:
Monday-Friday, 40 hours

Employment Type

Full-Time

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