Clinical Research Coordinator CRC and Regulatory ...

Pay: Up to $27.00 per hourJob title: Clinical Research Coordinator (CRC) with Regulatory Specialist ExpertiseJob descriptionPosition 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 leadershipWhat 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 backlogWe 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 sitesThis 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 accountableKey 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 flowJob Type: Full-timeSchedule:· Monday to Friday· Weekends as needed for regulatory deadlines or visitsWork Location: In person

Created: 2026-03-04