The CRA I will perform the following data management duties under general supervision by the Clinical Research Manager: • Verify adequate documentation of consent, required screening tests and procedures, and eligibility criteria to ensure patients meet all inclusion/exclusion criteria • Enroll patients as required by the study sponsor and internal enrollment monitor team • Follow patients for the duration of study participation via electronic medical record review to ensure protocol compliance • Complete data entry as required for individual study protocols ensuring compliance with institutional and regulatory requirements • 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 • Organize and prepare for internal and external audits • Maintain ongoing communication with clinical team regarding study patients and progress for multiple studies. The following regulatory duties may be performed under general supervision by the Clinical Research Manager: • 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.