Clinical Research Coordinator

Coordinate impactful clinical trials that drive medical innovation while safeguarding patient safety and data integrity. R&D Partners is seeking a Clinical Research Coordinator (CRC) who is a specialized research professional responsible for managing, facilitating, and coordinating daily clinical trial activities. The CRC plays a critical role in ensuring protocol compliance, data integrity, and participant safety from study initiation through completion. Applicants must have legal authorization to work in the United States. Responsibilities Independently conduct and manage assigned clinical trials in accordance with study protocols, GCP-ICH guidelines, FDA regulations, and company SOPs from site initiation through study close-out. Implement and coordinate all aspects of assigned trials, including start-up activities, vendor management, subject recruitment and retention, source document development, visit scheduling, regulatory document collection, protocol training, EDC data entry, query resolution, amendment implementation, and close-out reporting. Assist with study operations and workflow optimization to support successful protocol execution. Manage, monitor, and report adverse events, serious adverse events (SAEs), and protocol deviations to Sponsors and IRBs with accurate and timely documentation. Prepare for and lead monitoring visits, audits, and inspections; resolve data queries and protocol issues identified by monitors in a timely and professional manner. Perform procedures and assessments per protocol, including phlebotomy, ECGs, drug preparation and administration, and lab specimen processing. Evaluate and screen potential subjects for protocol eligibility; manage informed consent and participant retention activities. Collaborate with investigators, sponsors, CROs, labs, and internal teams to ensure protocol requirements are fully understood and consistently executed. Key Skills and Requirements Strong knowledge of GCP-ICH guidelines, FDA regulations, and clinical trial processes. Experience in clinical trial coordination, including start-up, monitoring, and close-out activities. Proficiency in EDC systems and query resolution. Ability to perform clinical procedures such as phlebotomy, ECGs, and drug administration. Excellent organizational, communication, and problem-solving skills. Ability to work independently and collaboratively in a fast-paced environment. #J-18808-Ljbffr