Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.
The PI is responsible for the safety of subjects who participate in clinical trials and for executing the study according to the IRB-approved protocol and applicable FDA and GCP regulations.
Pre-Study:
· 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.
During/Post 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.
