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.

Qualifications

• MD or DO degree and current state license.
• Basic Life Support and Advanced Cardiac Life Support certification
• Successful completion of an ACGME residency program in family medicine, internal medicine, or emergency medicine.
• Hold a DEA certificate for schedule II medications
• 3-5 years of medical/clinical experience preferred
• Clinical research experience preferred
• Able to work a flexible schedule