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 logsSkills/Abilities/Competencies Required· Careful attention to detail· Good organizational skills· Ability to follow directions· Good communication skills· Computer literacy· Working knowledge of clinical research protocols· Ability to demonstrate respect and professionalism for subjects rights and individual needsEducation· BA/BS degree requiredExperience · NoneSupervisory Responsibilities · NoneWorking Conditions· Duties will be performed primarily on-site in ambulatory and laboratory setting· Duties will be performed at both Massachusetts General Hospital and Brigham and Women’s Hospital· Components of the data/regulatory role may allow for remote work. The following clinical duties will be performed:· Assist clinical team in screening potential patients for study participation· Obtain informed consent for sample and data collection protocols· 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.