Clinical Research Coordinator

Prime Clinical Research Inc; Lewisville (TX); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

401(k)

Employee discounts

Health insurance

Paid time off

Job summary

Prime Clinical Research Inc. in Lewisville, TX is seeking a dedicated Clinical Research Coordinator to join our growing team.

You will coordinate day-to-day trial operations, screen and enroll participants, and manage data collection to ensure compliance with FDA and ICH-GCP guidelines. Ideal candidates have at least 1 year of clinical research coordination experience, familiarity with IRB processes, and certifications (CCRC/CCRP) are a plus.

Qualifications

• Bachelor's degree in health science, life science, or related field.
• 1+ years of clinical research coordination experience.
• Knowledge of FDA regulations, ICH-GCP and IRB processes.
• ACRP or SOCRA certification (CCRC/CCRP) is a plus.
• Strong organizational and communication skills.
• Proficiency with EDC systems and MS Office.

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.

Skills

Attention to detail

Organizational skills

Communication

Interpersonal skills

Education

Bachelor's degree in health science or life science

Tools

EDC systems

MS Office

Job description

Benefits:

• 401(k)
• Employee discounts
• Health insurance
• Paid time off

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.