Clinical Research Coordinator (Regulatory)

Clinical Research Coordinator (Regulatory) Prime Clinical Research Location: On‑Site Employment Type: Full‑Time Department: Clinical Operations Prime Clinical Research is seeking an experienced Clinical Research Coordinator with regulatory experience to support the day‑to‑day execution of clinical trials while also assisting with regulatory documentation and compliance activities. This role coordinates participant visits, supports study enrollment, maintains regulatory documentation, and ensures clinical trials are conducted in accordance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. Candidates with experience as a Clinical Research Coordinator (CRC) or Clinical Trials Coordinator are strongly encouraged to apply. What You Will Do Clinical Trial Coordination Screen potential research participants according to study eligibility criteria Coordinate and schedule participant visits including screening, baseline, and follow‑up visits Guide participants through the informed consent process and answer study‑related questions Visit Preparation and Execution Prepare charts, visit documentation, and study materials prior to participant visits Coordinate day‑of‑visit workflow and ensure protocol procedures are completed Clinical and Specimen Support Perform or assist with specimen collection including blood draws Process and document samples according to protocol requirements Data and Documentation Enter clinical study data into Electronic Data Capture (EDC) systems Maintain accurate source documentation and respond to sponsor data queries Regulatory Responsibilities Maintain Investigator Site Files (ISF) and regulatory binders Support IRB submissions, amendments, and continuing reviews Maintain delegation logs, training documentation, and essential study documents Track regulatory document expirations and investigator documentation Support monitoring visits, audits, and regulatory inspections Qualifications Required Bachelor’s degree in life sciences, healthcare, public health, or related field, or equivalent clinical research experience Minimum 2 years of clinical research experience as a Study Coordinator, Clinical Research Coordinator (CRC), or similar role Knowledge of ICH‑GCP guidelines Experience using Electronic Data Capture (EDC) systems Strong organizational and documentation skills Phlebotomy or specimen collection experience Preferred Clinical research certification (CCRC or CCRP) Experience maintaining regulatory binders or Investigator Site Files Experience supporting IRB submissions Compensation Salary Range: $45,000 – $55,000 depending on experience Prime Clinical Research is an Equal Opportunity Employer. #J-18808-Ljbffr HR Anew