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:

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Clinical Research Regulatory Specialist