What are the responsibilities and job description for the Clinical Research Regulatory Specialist position at Baptist Health Center for Clinical Research?
Seeking a detail-oriented Clinical Research Regulatory Assistant to support site compliance, manage regulatory documentation, and coordinate submissions across active clinical trials. This position provides direct support to the clinical research operations team and offers comprehensive training in trial startup, IRB processes, and FDA regulatory standards.
Key Responsibilities
- Documentation Management: Collect, organize, and maintain essential regulatory documents, including CVs, licenses, financial disclosures, and Delegation of Authority logs.
- Binder & File Auditing: Maintain electronic and physical regulatory binders (eTMF) to ensure audit-readiness and compliance with site Standard Operating Procedures (SOPs).
- IRB Support: Prepare baseline documentation for initial IRB submissions, amendments, continuing reviews, and safety updates under supervision.
- Site Startup Support: Assist with study startup tracking, vendor coordination, and document distribution for incoming clinical trial protocols.
- Safety & Tracking Logs: Track protocol deviations, safety alerts, and regulatory correspondence within the site’s Clinical Trial Management System (CTMS).
- Monitor Visit Preparation: Organize regulatory files and assist in resolving queries generated during sponsor monitoring visits and site audits.
Qualifications
- Education: High School Diploma or equivalent required; Associate or Bachelor’s degree in Business, Healthcare Administration, or Life Sciences preferred.
- Technical Skills: Advanced proficiency with Microsoft Office Suite (Excel, Word, Outlook, Teams) and aptitude for learning specialized database systems.
- Core Competencies: Exceptional attention to detail, time management, strong organizational skills, precise proofreading capabilities, and effective written communication.
- Professional Attributes: Ability to handle confidential data, manage multiple deadlines, and strictly follow detailed standard operating procedures.
Schedule & Location
- Full-time, Monday–Friday
- On-site
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Vision insurance
Work Location: In person