Monitor and report adverse events and deviations as required by the sponsor, institution, and federal regulations- Maintain research charts and/or electronic files for all enrolled patients- Ensure adequate source documentation is in place for all data reported- Resolve data queries issued by the sponsor- Obtain protocol clarifications from the study sponsor and communicate information to the research team- Schedule and prepare for monitoring visits with sponsors- Facilitate the request and shipment of archival pathology samples- Organize and prepare for internal and external audits- Maintain ongoing communication with clinical team regarding study patients and progress for multiple studiesThe following regulatory duties may be performed:- Maintain and organize study-specific regulatory binders- Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB- Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study- Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required- Submit Data and Safety Monitoring Reports- Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process- Collect, complete, and submit essential regulatory documents to various regulatory entities- Participate in monitoring visits and file all monitoring visit correspondence- Ensure appropriate documentation of delegation and training for all study staff members- Maintain screening and enrollment logs Qualifications . The following duties will be performed under general supervision by the Clinical Research Manager:- Assist clinical team in screening potential patients for study participation- Schedule all protocol required tests and procedures- Coordinate patient appointments with physicians, nurses, and all test areas- Coordinate and schedule clinical safety laboratory specimen draws and ensure timely results are available to providers- Prepare pre-visit communication for providers to ensure required assessments are completed and documented- Maintain point of contact communication with enrolled patients and assist with front line questions regarding study participation- Develop protocol specific flow charts, intake sheets, and other tools to ensure protocol compliance and proper data acquisition- Coordinate, obtain, process, and ship protocol required tissue samples- Ensure collection and processing (e.g.