About the Role:
Prime Clinical Research Inc. is looking for a dedicated and detail-oriented Clinical Research Coordinator to join our growing team in Lewisville, TX. This is an exciting opportunity to play a hands-on role in advancing medical research and improving patient outcomes. If you're passionate about clinical trials and making a real difference in healthcare, we want to hear from you!
Responsibilities:
- Coordinate and manage day-to-day clinical trial operations in compliance with FDA regulations and GCP guidelines
- Screen, enroll, and monitor study participants throughout the duration of clinical trials
- Collect, record, and maintain accurate study data and source documentation
- Serve as the primary point of contact between sponsors, IRBs, and study participants
- Prepare and submit regulatory documents, including IRB submissions and protocol amendments
- Conduct informed consent processes and ensure participant safety and confidentiality
- Support site audits, monitor visits, and ensure protocol adherence
Requirements:
- Bachelor's degree in a health science, life science, or related field preferred
- 1+ years of experience in clinical research coordination or a related clinical setting
- Knowledge of FDA regulations, ICH-GCP guidelines, and IRB processes
- ACRP or SOCRA certification (CCRC, CCRP) is a plus
- Strong organizational skills with exceptional attention to detail
- Excellent communication and interpersonal skills for working with patients and sponsors
- Proficiency with electronic data capture (EDC) systems and MS Office
About Us:
Prime Clinical Research Inc. is a trusted clinical research site based in Lewisville, TX, committed to conducting high-quality trials that bring innovative treatments to patients. Our team is known for its dedication to participant safety, data integrity, and scientific excellence. We foster a collaborative and supportive work environment where every team member plays a vital role in advancing the future of medicine.