Clinical Research Coordinator (32211)

Work to build the research department in scope, size, reputation, and professionalism. Research Coordinator 06.2020 • Assist with recruitment of studies, budget evaluation and negotiation, protocol evaluation, communication with study sponsors. • Maintain certifications in, and continually update knowledge of, FDA, GCP, ICH, federal and state regulations, etc. • Obtain and maintain consent of patients with the highest ethical standards. • Work with other research department staff in a leadership role including management, training, delegation of responsibilities, hiring, etc. • Work directly with patients to screen, consent, take history, complete necessary exams including EKG, blood draw, vitals, etc. • Communicate with and support patients and their families as necessary. • Work with the EMR and data management systems to complete EDC, eCRFs, find patients, maintain records. • Must have or gain knowledge of relevant software/programs. • Have a basic and working knowledge of trial design, statistical methods, etc. • Triage, record, and report adverse events. Record and report any protocol deviations. • Work closely with IRB and study sponsors, PIs and Sub-Is. Attend necessary meetings and calls. • Create and maintain department SOPs, NDAs, CVs, certifications, etc. • Evaluate, purchase, maintain necessary equipment. • Maintain HIPAA compliant communication and confidentiality, at all times. • Maintain study budgets and monitor invoicing, billing, and payments. • Participate in site visits, SIVs, monitoring, etc. • Complete necessary study close-out steps and documentation. • Assist with other duties assigned.