Clinical Research Coordinator

Study Coordinator – Clinical Research (Regulatory)

Prime Clinical Research

Location:

On-Site

Employment Type:

Full-Time
Department:
Clinical Operations

Prime Clinical Research is seeking an experienced Study Coordinator 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.

• 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

• Prepare charts, visit documentation, and study materials prior to participant visits
• Coordinate day-of-visit workflow and ensure protocol procedures are completed

• Perform or assist with specimen collection including blood draws
• Process and document samples according to protocol requirements

• Enter clinical study data into Electronic Data Capture (EDC) systems
• Maintain accurate source documentation and respond to sponsor data queries

• 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

• 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

• Clinical research certification (CCRC or CCRP)
• Experience maintaining regulatory binders or Investigator Site Files
• Experience supporting IRB submissions

Salary Range: $45,000 – $55,000 depending on experience

Prime Clinical Research conducts clinical trials in partnership with pharmaceutical companies, biotechnology organizations, and contract research organizations. Our mission is to advance medical innovation while maintaining the highest standards of patient safety, regulatory compliance, and research quality.

Prime Clinical Research is an Equal Opportunity Employer.