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

#J-18808-Ljbffr