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.

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Clinical Research Coordinator (32211)