Clinical Research Coordinator (32211)

About the role

Work to build the research department in scope, size, reputation, and professionalism.

Responsibilities

• 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.
• 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.