The Clinical Research Coordinator (CRC) manages and coordinates clinical research studies,
ensuring they are conducted efficiently, ethically, and in compliance with regulatory requirements. The role involves working with principal investigators, research staff, and study participants to oversee all aspects of trials, including recruitment, data management, regulatory compliance, and monitoring participant progress.
- Screens and recruits subjects.
- Communicates with subjects and medical group providers, including the Principal Investigator and any Sub-Investigators.
- Collects, labels, stores, and ships specimens collected from subjects in connection with a clinical research trial.
- Enters patient and research data in systems designated by the company.
- Monitors study activities to ensure compliance with study protocols and with applicable federal, state, and local regulatory and site requirements.
- Oversees subject enrollment to ensure that informed consent is properly obtained and documented.
- Records adverse events and side effect data and confers with Investigators regarding reporting of events to oversight agencies.
- Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
- Doses and administers study drugs and / or implements study methodologies.