Clinical Research Coordinator CRC and Regulatory Specialist
Listed on 2026-01-12
-
Healthcare
Clinical Research
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
· On-time IRB submissions and approvals for ≥95% of initial, amendment, and continuing review packages
· Zero overdue safety reports and protocol deviation submissions
· eReg/TMF and regulatory binder 100% inspection-ready at all times
· Consent version control accuracy at 100% with timely re-consents
· Query turnaround ≤2 business days for sponsor/CRO requests
· Reliable support of 6–10 patient visits per 8.5-hour day without documentation backlog
We will help you do a great job through Prime Clinical Research Inc.’s onboarding
· eReg/eTMF fundamentals and version control
· IRB/IEC submissions, amendments, and continuing review best practices
· Safety reporting workflows (SAE/SUSAR notifications and timelines)
· Source, EDC, and CTMS efficiency to end each day with tasks complete
· Time management for deadlines and work-life balance
· Communication with sponsors, CROs, and sites
This opportunity is perfect for the study coordinator who
· Has a strong work ethic and meets deadlines
· Learns quickly and applies feedback
· Works well on cross-functional teams
· Is organized, proactive, and accountable
Key Responsibilities
Regulatory Submissions:
Prepare and submit initial IRB packages, amendments, safety letters, annual/continuing reviews, and study closures; maintain submission trackers.
Informed Consent Management:
Control versions, prepare ICFs, train staff on updates, verify correct consent at each visit, and oversee timely re-consent.
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.
Safety Reporting:
Triage and submit SAEs, SUSARs, and significant deviations per timelines; document follow-up and correspondence.
Compliance & QA:
Ensure GCP, ICH, FDA, and site SOP adherence; conduct internal QC, prep for monitoring visits, audits, and inspections; resolve findings promptly.
Start-Up to Close-Out:
Support Feasibility, SIV readiness, site activation, recruitment materials approvals, and study close-out documentation.
Visit Coordination Support:
Schedule visits, verify eligibility documentation, assist source creation, and ensure same-day EDC entry and reconciliation.
Communication:
Serve as regulatory point of contact for sponsor/CRO/IRB; maintain clear, timely correspondence and meeting notes.
Recruitment Support:
Coordinate IRB-approved outreach materials and logs in compliance with privacy and protocol.
Administrative Tasks:
Maintain calendars, trackers, and CTMS; file emails and letters in eTMF/eReg; assist billing/grant compliance documentation as needed.
Qualifications
· 3–5 years clinical trial experience required, with 1–3 years in site regulatory submissions and maintenance
· High school diploma or equivalent required;
Associate or Bachelor’s preferred
· Current Good Clinical Practice (GCP) certification required
· ACRP-CP or SoCRA CCRP preferred; CIP a plus
· Bilingual Spanish/English strongly preferred
· Proficiency with eReg/eTMF, IRB portals, CTMS, EDC, and standard office software
· Strong knowledge of ICH-GCP, FDA regulations, and site SOPs
· Excellent written and verbal communication; strong organization and attention to detail
· Ability to manage multiple deadlines and support patient visit flow
Job Type: Full-time
Schedule:
· Monday to Friday
· Weekends as needed for regulatory deadlines or visits
Work Location:
In person
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