Clinical Research Coordinator — Lead Patient-Centric Trials

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

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.