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Clinical Research Coordinator (CRC) and Regulatory Specialist

Clinical Research Coordinator (CRC) and Regulatory Specialist

PRIME CLINICAL RESEARCH INCLewisville, TX, US
11 days ago
Job type
  • Full-time
Job description

Job Description

Job Description

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

    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

  • 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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    Clinical Research Coordinator • Lewisville, TX, US