Study Coordinator Clinical Research Regulatory
HR Anew, Farmers Branch, TX, United States
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.
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
About Prime Clinical Research
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.
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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.
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
About Prime Clinical Research
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.
#J-18808-Ljbffr