Company Description Orange County Research Center is a premier clinical research facility specializing in Phase I–IV clinical trials across diverse therapeutic areas. With decades of experience and a state-of-the-art Phase I unit, the center supports sponsors and CROs in conducting high-quality, compliant, and efficient studies. A multidisciplinary team collaborates to ensure robust study design, accurate data collection, and timely execution. The organization is dedicated to scientific excellence, participant safety, and operational integrity, advancing innovative therapies that improve patient outcomes. Team members join a mission-driven environment focused on rigorous research and meaningful clinical impact.
Role Description The Senior Clinical Research Coordinator is a full-time, on-site role based in Lake Forest, CA. This position oversees the planning, coordination, and execution of clinical trials, including participant screening, enrollment, and follow-up visits according to study protocols. Day-to-day responsibilities include managing informed consent processes, maintaining source documentation and regulatory binders, scheduling and conducting study procedures, and ensuring protocol adherence. The coordinator collaborates closely with investigators, sponsors, and internal teams to support monitoring visits, resolve queries, and maintain data accuracy and timeliness. The role also involves training junior staff, supporting quality assurance activities, and promoting best practices in participant safety and compliance.
Qualifications
• Demonstrated clinical research experience with involvement in Clinical Trials and strong Research skills.
• Proficiency in managing Informed Consent processes, including educating participants and ensuring proper documentation.
• Experience interpreting and implementing study Protocols with attention to regulatory and ethical requirements.
• Knowledge of Good Clinical Practice (GCP), ICH guidelines, and applicable FDA and IRB regulations.
• Strong organizational, time-management, and documentation skills, with high attention to detail.
• Effective written and verbal communication skills and ability to collaborate with multidisciplinary teams.
• Prior experience as a Clinical Research Coordinator, preferably in Phase I–IV trials; senior or lead experience is highly desirable.
• Associate or Bachelor’s degree in a health-related field or equivalent experience; professional certification in clinical research (e.g., ACRP, SOCRA) is a plus.
• Ability to work on-site in Lake Forest, CA, including occasional extended hours to support study needs.