Clinical Research Coordinator II
On-sitePlano, Texas, United States
Job Summary
Independently coordinate and manage industry-sponsored clinical trials from study start-up through closeout with minimal supervision. Manage complex study visit schedules and protocol-related activities while ensuring adherence to study timelines, requirements, and GCP guidelines. Lead patient recruitment and retention efforts including chart review, informed consent discussions, and enrollment tracking. Conduct protocol-required patient visits and assessments, perform clinical procedures such as vital signs and phlebotomy, and process laboratory specimens per IATA regulations. Maintain accurate study documentation, ensure high-quality data entry, and serve as the primary point of contact for study participants. Prepare for sponsor and regulatory monitoring visits, review safety reports, and maintain inventory of study equipment and investigational products. Contribute to process improvement initiatives and support the protection of human research participants in compliance with federal regulations.
Required Qualifications
- Associate's or Bachelor's degree in a scientific, healthcare, or related discipline
- 3-5 years of clinical research or healthcare experience
Desired Qualifications
- Experience in [gastroenterology, hepatology, cardiology] therapeutic areas
- CCRC® — Certified Clinical Research Coordinator or CCRP® — Certified Clinical Research Professional or equivalent clinical research certification
- Familiarity with CTMS or EDC systems
- Strong organizational skills and attention to detail
- Ability to manage competing priorities in a fast-paced environment
- Ability to read, interpret, and apply research protocols and clinic policies
- Proficiency with CTMS, EDC systems, and standard office software applications
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