Regulatory Specialist for Center for Anesthesia Research Excellence
Beth Israel Lahey Health•Boston, MA
•$60,008 - $88,005
About The Position
The Regulatory Specialist supports regulatory compliance for clinical research at Beth Israel Deaconess Medical Center (BIDMC). This role involves preparing and submitting various regulatory documents, overseeing reporting, and acting as a liaison between the IRB and investigators to ensure compliance with FDA, cooperative group, NCI, and OHRP guidelines.
Requirements
- Bachelor's degree required
- 1-3 years related work experience required
- Must demonstrate good understanding of FDA, cooperative group, NCI and OHRP regulatory guidelines.
- Must maintain confidential and sensitive information, set own priorities, and work both independently and collaboratively with other research and hospital personnel.
- Experience with computer systems required, including web based applications and some Microsoft Office applications which may include Outlook, Word, Excel, PowerPoint or Access.
Nice To Haves
- Master's degree preferred in Regulatory Affairs
- 1-3 years of clinical trial regulatory affairs experience preferred
Responsibilities
- Prepare and submit applications (industry, cooperative groups and PI initiated studies), respond to IRB comments on applications submitted and work with study team in getting studies activated for enrollment of patients.
- Prepare and assist in submission of protocol amendments, IND safety reports, ADEERS submission, consent form changes, continuing reviews, violations and deviations to study protocols.
- Oversees reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other study documents to support regulatory compliance and troubleshoots processes and procedures when issues are identified.
- Assist investigators and study teams in preparing and submitting IND applications to the FDA.
- Preparation and submission of annual reports to the FDA; submission of regulatory documents to NIH/OBA, local bio safety committees on oncology human gene transfer trials.
- Act as a liaison between the IRB and investigator to resolve regulatory queries and concerns.
- Assist in the preparation and implementation of regulatory office SOPs.
Benefits
- Vaccinated against influenza (flu)
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
