CRA

Major Responsibilities and Duties 01. Ensure all business is conducted professionally in compliance with company policies and procedures. 02. Maintains working knowledge of protocols and Monitoring Plans for assigned projects. 03. Responsible for leading the EC submission team for GCP office pre-review and EC submission to meet start up timeline. 04. Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period; 05. Responsible for scheduling and conducting of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan. 06. Ensures assigned sites are conducting studies according to protocol requirements. 07. Reconciles site regulatory binder assuring collection and completeness of regulatory documents. 08. Collects and ensures completeness of all essential regulatory documentation from sites from study start-up through close-out. 09. Verifies that written informed consent was obtained before each subject’s participation in the trial; 10. Verifies that the investigator is enrolling only eligible subjects. 11. Performs verification of source document s 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. 12. Issues and ensures timely resolution of all data queries.