What are the responsibilities and job description for the Clinical Research Coordinator position at Orange County Research Center?
Company Description Orange County Research Center is a premier clinical research facility specializing in Phase I–IV clinical trials across a wide range of therapeutic areas. With decades of experience and a state-of-the-art Phase I unit, the organization supports sponsors and CROs with high-quality, compliant, and efficient study execution. A multidisciplinary team of clinical professionals ensures rigorous data collection and adherence to regulatory standards. The center is strongly committed to scientific excellence, participant safety, and operational integrity. Team members contribute directly to the advancement of innovative therapies that can improve patient outcomes.
Role Description This is a full-time, on-site Clinical Research Coordinator role based in Lake Forest, CA. The Clinical Research Coordinator will oversee day-to-day conduct of clinical trials, including scheduling and coordinating participant visits, collecting and documenting study data, and maintaining accurate source documents and case report forms. Responsibilities include managing informed consent processes, ensuring adherence to study protocols, and monitoring participant safety through ongoing assessments and reporting of adverse events. The coordinator will collaborate with investigators, nurses, sponsors, and CROs to support start-up activities, regulatory submissions, and timely study milestones. Additional duties include maintaining study logs, organizing study supplies, assisting with monitoring visits and audits, and ensuring compliance with GCP, IRB requirements, and site SOPs.
Qualifications
Role Description This is a full-time, on-site Clinical Research Coordinator role based in Lake Forest, CA. The Clinical Research Coordinator will oversee day-to-day conduct of clinical trials, including scheduling and coordinating participant visits, collecting and documenting study data, and maintaining accurate source documents and case report forms. Responsibilities include managing informed consent processes, ensuring adherence to study protocols, and monitoring participant safety through ongoing assessments and reporting of adverse events. The coordinator will collaborate with investigators, nurses, sponsors, and CROs to support start-up activities, regulatory submissions, and timely study milestones. Additional duties include maintaining study logs, organizing study supplies, assisting with monitoring visits and audits, and ensuring compliance with GCP, IRB requirements, and site SOPs.
Qualifications
- Strong foundation in clinical research principles, including hands-on Research and Clinical Research Experience.
- Proficiency in managing Informed Consent processes and ensuring ethical, participant-centered communication.
- Ability to interpret and implement study Protocol requirements and maintain strict protocol compliance.
- Experience coordinating Clinical Trials, including visit management, data collection, and regulatory documentation.
- Knowledge of GCP, FDA regulations, and IRB processes, with excellent attention to detail and documentation skills.
- Effective written and verbal communication skills, with the ability to collaborate across multidisciplinary teams.
- Strong organizational and time-management skills, with the ability to prioritize multiple studies and deadlines.
- Proficiency with electronic data capture systems and standard office software (e.g., EDC platforms, Excel, Word).
- Preferred: Bachelor’s degree in a health-related field (e.g., life sciences, nursing, public health) or equivalent experience.
- Preferred: Prior experience in Phase I–IV studies and familiarity with early-phase clinical unit operations.