Clinical Research Regulatory Coordinator I

Job Summary

The Clinical Research Regulatory Coordinator I (CRRCI) works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact.

Principal Duties And Responsibilities

The following regulatory duties will be performed under general supervision by the Clinical Research Manager:

• Maintain and organize study specific regulatory binders
• Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB
• Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study
• Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required
• Submit Data and Safety Monitoring Reports
• Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process
• Collect, complete, and submit essential regulatory documents to various regulatory entities
• Participate in monitoring visits and file all monitoring visit correspondence
• Ensure appropriate documentation of delegation and training for all study staff members
• Maintain screening and enrollment logs

Skills/Abilities/Competencies Required

• Careful attention to detail
• Good organizational skills
• Ability to follow directions
• Good communication skills
• Computer literacy
• Working knowledge of clinical research protocols

Qualifications

Education: Bachelor's Degree in a related field required.

Experience: Knowledge, skills, and abilities as listed above.

Pay & Schedule

• Remote Type: Remote
• Work Location: 101 Merrimac Street
• Scheduled Weekly Hours: 40
• Employee Type: Regular
• Work Shift: Day (United States of America)
• Pay Range: $20.16 – $29.01/Hourly