Project Manager B: Protocol Development, Clinical Statistics and Data Analyses

Description

Job Responsibilities
Investigator Initiated Protocol/Study Specific
· Collaborate with Cardiac Surgeon/PIs to define study objectives and requirements on investigator initiated clinical trials
(IDE and IND)
· Design and draft detailed investigator initiated protocols (including eligibility, screening, study assessments) that comply
with regulatory standards
· Design and draft informed patient consent forms specific to each investigator initiated protocol
· Liaisons with statisticians, Surgeon PIs, co-investigators, clinical trials support staff on all trials
· Expand non-scientific sections of protocols with minimal oversight
· Review and revise investigator initiated protocols based on feedback from federal, state and local regulatory authorities.
Prepare annual reports for regulatory authorities.
· Provide ongoing training and study start-up for investigator initiated studies
· Develop study sp...