The Clinical Research Coordinator (CRC) is responsible for managing the day-to-day operations of clinical trials, ensuring that studies are conducted in accordance with established protocols, regulatory requirements, and ethical standards. This role plays a critical part in maintaining the integrity of clinical research and safeguarding participant well-being.
Coordinate and oversee daily clinical trial activities from initiation through closeout
Recruit, screen, and enroll study participants in accordance with protocol requirements
Obtain and document informed consent from study participants
Schedule and manage study visits, procedures, and follow-ups
Collect, record, and maintain accurate and timely study data
Monitor participant safety and report adverse events per regulatory guidelines
Ensure compliance with Good Clinical Practice (GCP), FDA, and Institutional Review Board (IRB) regulations
Maintain and organize essential study documentation, including regulatory binders and source documents
Serve as a liaison between investigators, sponsors, study participants, and other stakeholders
Assist with study audits, monitoring visits, and regulatory inspections
Bachelor’s degree in life sciences, healthcare, or a related field (or equivalent experience)
Prior experience in clinical research or healthcare setting preferred
Knowledge of GCP, FDA regulations, and IRB processes
Strong organizational, communication, and multitasking skills
Attention to detail and ability to maintain accurate documentation
Proficiency with electronic data capture (EDC) systems and Microsoft Office
