Rochester, NY30+ days ago
Under the supervision of the clinical trial projects manager and the PI, provides data clarifications, reviews study protocols, ensures thorough understanding and communication, responds to questions that arise during the study, communicates and documents adverse events as advised by the PI, and ensures regulatory and other documents, such as consent forms and CRFs, are complete, accurate, and available for review. Conducts visits to ensure research participant adherence with protocol requirements, such as assisting in consenting, taking of medications, proper use of device, and/or other interventional activities, to document adverse events and report to senior study staff, PI, Institutional Review Board (IRB), Sponsor, and/or any other required recipients or entities.