What are the responsibilities and job description for the Clinical Research Regulatory Specialist position at Semmes Murphey Foundation?
Description
Essential Duties and Responsibilities:
- Prepare, submit, and track IRB applications for new studies, amendments, continuing reviews, and study closures
- Serve as a regulatory resource for investigators and research staff; assist with regulatory education and SOP adherence
- Facilitate contract and budget administration by coordinating IRB, sponsor organizations, physicians, outside counsel, and internal staff to keep projects on track
- Maintains regulatory binders and essential documents in compliance with FDA, CFR, ICH-GCP, HIPAA, and institutional policies
- Support internal audits, sponsor monitoring visits, and regulatory inspections; maintain audit-ready files
- Assist with data reporting, electronic data entry, and administrative study tasks as required by protocol
- Support quality initiatives and regulatory process improvements in collaboration with the Clinical Research Manager
Requirements
MINIMUM:
- Bachelor's degree in health sciences, life sciences, public health, healthcare administration, or related field
- Two or more years of clinical research experience; preferably with demonstrated regulatory and IRB submission responsibilities
PREFERRED:
- Five plus years of clinical research regulatory experience
- Master's degree in related field
- Professional certifications such as CCRC (ACRP) or CCRP (SOCRA)
- Experience supporting multi-site or industry-sponsored clinical trials
Additional required skills include a working knowledge of FDA regulations (e.g. 21 CFR Parts 50, 54, 56, and 312/812 as applicable), the clinical trial process, and ICH-GCP guidelines. This role requires strong organizational skills and a high attention to detail.
Equal Opportunity Employer/Veterans/Disabled
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