Clinical Research Coordinator - Unblinded - Contract

Clinical Research Coordinator - Unblinded - Contract Contract placement at M3 Wake Research, an M3USA Company. This on-site position requires a Clinical Research Coordinator (contract/PRN) to support site‑based trial execution by ensuring compliance with ICH/GCP, FDA regulations, sponsor requirements, and site SOPs. Responsibilities Completes all site course requirements, including GCP, IATA, OSHA, site SOP review, and study related courses. Cooperates with site management and monitoring efforts to ensure protocol adherence and reports instances of non‑compliance or external inspections/audits immediately. Coordinates with site management/PI to ensure that clinical research protocol and related activities are performed in accordance with ICH/GCP, federal regulations, Research site SOPs and sponsoring agency policies. Reviews and adheres to assigned protocol, including study procedures, timelines, and inclusion/exclusion criteria. Establishes and maintains study files, including regulatory binders, source documents, and other materials. Assists with regulatory duties such as providing study training tools, maintaining Delegation of Authority Log, sponsor and vendor communications, IP/device documentation. Conducts the informed consent process with research participants per the site’s SOP, obtains signatures and dates, and ensures amended consent forms are implemented. Performs delegated study procedures (vital signs, EKG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood, or other protocol‑required procedures) and documents appropriately on source documents. Obtains and reviews participant’s medical history, concomitant medication history and inclusion/exclusion criteria. Assists with timely completion of case report forms, if appropriately delegated/trained. Maintains adequate inventory of all study supplies and follows protocol for investigational drug/device accountability. Assists fellow co‑workers with studies as time and ability permit. Qualifications Knowledge of FDA regulations, ICH Good Clinical Practices (GCP) and ISO standards. Successful completion of the GCP certification. Phlebotomy and EKG experience. +2 years of CRC experience is preferred. Benefits 401(k) with matching. Disability insurance. Employee assistance program. Flexible spending account. Health insurance. Life insurance. Paid time off. Vision insurance. #J-18808-Ljbffr