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

• 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