Clinical Research Coordinator (CRC) and Regulatory Specialist

Pay : Up to $27.00 per hour

Job title : Clinical Research Coordinator (CRC) with Regulatory Specialist Expertise

Job description

Position Overview : Prime Clinical Research seeks a full-time Clinical Research Coordinator with strong regulatory specialist experience. The ideal candidate has hands-on CRC skills plus proven IRB / IEC submission experience, mastery of essential documents, and audit-ready eReg / TMF practices. This role supports compliant study start-up, maintenance, and close-out while coordinating patient visits. Pay is negotiable based on experience.

Why us?

• Collaborative team of clinical and non-clinical staff
• Direct mentorship from experienced Investigators and leadership

What doing a great job will look like

We will help you do a great job through Prime Clinical Research Inc.’s onboarding

This opportunity is perfect for the study coordinator who

Key Responsibilities

1. Regulatory Submissions : Prepare and submit initial IRB packages, amendments, safety letters, annual / continuing reviews, and study closures; maintain submission trackers.

2. Informed Consent Management : Control versions, prepare ICFs, train staff on updates, verify correct consent at each visit, and oversee timely re-consent.

3. Essential Documents & eReg / TMF : Build and maintain investigator site files and eReg / eTMF; collect and track 1572s, FDFs, CVs / licenses, training logs, lab certs, delegation logs.

4. Safety Reporting : Triage and submit SAEs, SUSARs, and significant deviations per timelines; document follow-up and correspondence.

5. Compliance & QA : Ensure GCP, ICH, FDA, and site SOP adherence; conduct internal QC, prep for monitoring visits, audits, and inspections; resolve findings promptly.

6. Start-Up to Close-Out : Support Feasibility, SIV readiness, site activation, recruitment materials approvals, and study close-out documentation.

7. Visit Coordination Support : Schedule visits, verify eligibility documentation, assist source creation, and ensure same-day EDC entry and reconciliation.

8. Communication : Serve as regulatory point of contact for sponsor / CRO / IRB; maintain clear, timely correspondence and meeting notes.

9. Recruitment Support : Coordinate IRB-approved outreach materials and logs in compliance with privacy and protocol.

10. Administrative Tasks : Maintain calendars, trackers, and CTMS; file emails and letters in eTMF / eReg; assist billing / grant compliance documentation as needed.

Qualifications

Job Type : Full-time

Schedule :

Work Location : In person