Responsible for scheduling and conduct of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan.
Ensures the HGRAC and IRB submission and approval.
Ensures assigned sites are conducting studies according to protocol requirements and applicable regulations and guidelines.
Ensure that the rights and wellbeing of human subjects are protected.
Ensure the trial data are accurate, complete, and verifiable from source documents.
Verifies that the investigator is enrolling only eligible subjects.
Performs verification of source documents against Case Report Form/Electronic Data Capture entries to assure accurate and complete data.
Ensures that any corrections are appropriately documented by authorized site staff.
Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensi...