Clinical Research Coordinator (On-Site)

HR Anew•Lewisville and Mansfield, TX

19h•Onsite

About The Position

Prime Clinical Research is seeking an experienced Clinical Research Coordinator to support the day-to-day execution of clinical trials and assist with regulatory documentation and compliance activities. The role coordinates participant visits, supports study enrollment, maintains regulatory documentation, and helps ensure trials are conducted in accordance with study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines. The position is on-site in Mansfield and Lewisville, Texas, within Clinical Operations, and is full-time. Prime Clinical Research conducts clinical trials in partnership with pharmaceutical companies, biotechnology organizations, and contract research organizations. Its mission is to advance medical innovation while maintaining high standards of patient safety, regulatory compliance, and research quality. The company is an Equal Opportunity Employer.

Requirements

Bachelor’s degree in life sciences, healthcare, public health, or a related field, or equivalent clinical research experience.
At least 2 years of clinical research experience as a Study Coordinator, Clinical Research Coordinator (CRC), or in a 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 screening, baseline, and follow-up participant visits.
Guide participants through informed consent and answer study-related questions.
Prepare charts, visit documentation, and study materials before participant visits.
Coordinate day-of-visit workflows 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.