Clinical Research Coordinator

Job Title Clinical Research Coordinator Reports to CRC Manager Job Summary/ Objective The Clinical Research Coordinator is responsible for supporting the management and oversight of clinical trials. This role involves working closely with a team to ensure the smooth execution of research studies under the guidance of the Investigator and CRC Manager, Site Operations Manager, or Project Director. Essential Functions Overseeing Clinical Trials Ensure smooth conduct of study visits and clinical trials. Monitor study participants’ health throughout the trial. Schedule study visits within protocol-required timelines. Coordinate lab work, imaging, and other required procedures. Document all aspects of study visit and subject status. Data Collection and Management Collect and enter data obtained from study visits into source document, study logs, EMR, and EDC where data management personnel are not assigned. Assist data management team with resolution of queries. Participant Interaction Educate study participants about study objectives and visit procedures. Communicate with study participants regarding any adverse events or side effects and the management of them. Monitor participant's adherence to protocol guidelines. Collaboration and Compliance Liaise with laboratories. Liaise with Imaging vendors. Liaise with pharmacy staff and infusion nurses. Liaise with regulatory and quality assurance departments on protocol adherence and documents. Monitor study compliance with protocols and ethical standards. Ensure adherence to regulatory requirements. Record Keeping Maintain research records, including source documents, study logs, case report forms, and EMR. Direct specimen collection, labeling, packaging, transport, shipping, and storage. Logistics and Supplies Ensure all necessary equipment is functional, and supplies are in stock. Education/Experience/Skills Education: Bachelor's degree preferred in a health-related field. Experience: 1 year of experience in Clinical Research; may consider less experience if upskilled from a research assistant role within the company. Regulatory Accessing and filing documents. Assist with study submissions. Report protocol deviations and SAEs to the IRB (where not performed by Research Navigator). Finance Stipend payments. Confirm study procedures are included in the budget. Insurance Coordination. Subject Interaction Schedule, screen, and enroll subjects. Collect medical history. Conduct study visits. Administrative EDC Data Entry (where Data Management role is not doing this task). Query resolution. AE/SAE documentation and reporting. Order/make maintain supplies. Manage medical records. Clinical Skills Vital Signs. EKG. Order and organize lab kits and corresponding reports. Working Conditions/ Physical Demands Standard operating hours are Monday through Friday, 8:00 a.m. to 5:00 p.m. #J-18808-Ljbffr Green Key Resources