- Ensure completeness and compile regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB approval, informed consent, lab certification, etc.).- Provide applicable updates for site-related documentation for filing in the Trial Master File (TMF).- Assist in monitoring visit preparation and/or follow-up such as teleconference arrangements, regulatory file review, and agenda preparation.- Assist with ensuring site compliance with IP receipt, accountability, and return or destruction, as applicable and appropriate.- Assist in preparing the Site Initiation Visit presentation or review of clinical monitoring plans.- Conduct qualification, study initiation, and interim monitoring visits under the guidance of the local CRA or Lead CRA/PM, as applicable and appropriate.- Perform feasibility studies/site identification activities for potential sites, as requested.- Document site findings and site visits via written reports, under the guidance of the local CRA or Lead CRA/PM, as applicable and appropriate.

- Coordinated study conduct with other departments to effectively implement clinical research projects; obtained required letters of support and/or approvals as needed (i.e. IBC, SRC, etc.), and protocol followed.- Conducted study start-up activities and prepared and maintained all regulatory documents required by sponsors and/or regulatory agencies.- Adhered to research protocol in compliance with applicable institutional, local, and federal regulations (OHRP, FDA, GCP, etc.).- Identified and recruited eligible study subjects; conducted informed consent/assent process.- Conducted literature searches and assisted with QA/QC procedures.- Monitored/assessed adverse events and reported them as required.