· Review protocol and Investigator Brochure for subject safety, scientific, and operational feasibility of study. Provide input to sponsor as indicated.
· Complete FDA 1572 and financial disclosure forms.
· Attend study initiation meetings with sponsor.
· Communicate with Institutional Review Board during protocol approval process and subject safety issues.
· Explain study to subject and answer questions, ensure proper consent, and perform screening examination.
· Final review of all screening data and authorization of subjects to be enrolled in the study.
· Perform scheduled per protocol, and unscheduled per adverse event, physicals during study conduct.
· Manage adverse events/clinical evaluation of subjects and determine adverse event relationship to investigational product, severity, and etiology. Review pre-dose lab work, ECGs, and other study data and determine appropriate action plan based on these results. Review safety data with sponsor.
· Compose SAE and other reporting documents as indicated.
· Review and sign Case Report Forms and final Clinical Study Reports.
· Review all serious adverse events and SUSARs to the Sponsor and IRB within statutory timelines
· Data review of all end-of-study data to determine if re-checks are necessary
· Safety-monitoring – perform end-of-study physical exams and follow-up ongoing adverse events
· Case Report Forms review – review and sign all case report forms at end of study
· Assist in on-site client review of case report forms
Additional Responsibilities:
· Assist with identifying and maintaining a network of physician specialists to contract on studies.
· Present Celerion’s capabilities and experience during sponsor meetings and events.
· Assist in the design of study and time/event schedules involving special medical procedures
· Function as a medical/clinical informational resource for the site.
· Assist other departments with development of SOPs, training plans, etc.
· Facilitate emergency response training and review of clinical safety procedures.