Clinical Research Regulatory Coordinator I

About This Opportunity

We are representing a major healthcare system seeking a Clinical Research Regulatory Coordinator I to join their research operations team. This remote position focuses on ensuring regulatory compliance for clinical trials through meticulous documentation, IRB coordination, and sponsor communication. You'll work under general supervision to maintain study integrity and meet federal requirements—no patient contact involved.

Responsibilities

• Maintain and organize study-specific regulatory binders for multiple clinical trials
• Prepare and submit protocol amendments, continuing reviews, and safety reports to Institutional Review Boards
• Revise informed consent documents to reflect new risk information and updated protocol requirements
• Manage adverse event and deviation documentation for enrolled patients; report to sponsors and IRBs as required
• Submit Data and Safety Monitoring Reports according to protocol timelines
• Maintain source documentation of all correspondence with IRBs, investigators, and sponsors
• Collect, complete, and submit essential regulatory documents to various regulatory entities
• Participate in monitoring visits and file all related correspondence
• Ensure proper documentation of delegation of authority and training for study staff members
• Maintain accurate screening and enrollment logs

What We're Looking For

• Education: Bachelor's degree in a related field required
• Exceptional attention to detail and ability to maintain accuracy across complex documentation
• Strong organizational skills with ability to manage multiple studies simultaneously
• Excellent ability to follow detailed directions and regulatory guidelines
• Proficient computer literacy and comfort learning specialized research software
• Working knowledge of clinical research protocols and regulatory frameworks
• Strong written and verbal communication skills for interacting with research teams, sponsors, and regulatory bodies
• Ability to work independently in a remote environment while maintaining collaborative relationships

How We Work With You

When you apply through Get A Job.ai, our recruiting team will review your qualifications and conduct an initial screening. If your background aligns with our client's needs, we will submit your profile for consideration and coordinate all communication throughout the interview process. Please apply exclusively through Get A Job.ai—do not contact the employer directly.

Pay

Compensation details will be discussed during the screening process based on your qualifications and our client's budget parameters.

Equal Employment Opportunity: Get A Job.ai is committed to inclusive hiring practices. We welcome applicants of all backgrounds and provide reasonable accommodations throughout our recruitment process.