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
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
Bilingual English/Spanish preferred in AZ
Able to work a flexible schedule
Celerion Values: Integrity Trust Teamwork Respect
Are you ready to join our team?
Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.
Seniority level
Not Applicable
Employment type
Full-time
Job function
Other, Information Technology, and Management
Industries
Software Development
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