Clinical Research Coordinator (On-Site)
HR Anew•Mansfield and Lewisville, TX
•Onsite
About The Position
Prime Clinical Research is seeking an experienced Clinical Research 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.
Requirements
- 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
Nice To Haves
- Clinical research certification (CCRC or CCRP)
- Experience maintaining regulatory binders or Investigator Site Files
- Experience supporting IRB submissions
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
