Clinical Research Coordinator

Coordinates and assures integrity of all activities associated with conducting TBICoE TBI clinical investigations as it relates to compliance with local, state, and/or federal regulatory requirements.Assists Principal / Associate Investigators in the preparation and submission of clinical protocols, consent forms and other documents to the scientific review committee, IRB and other regulatory organizations.Prepares requests for actions/proposals to include assisting with and providing coordination for grant proposal applications and their associated documentations and requirements as needed. Facilitates the flow and approval processes for relevant projects as needed or requested.Maintains regulatory files related to TBICoE clinical investigations.Communicates with research participants, staff, regulatory affairs and data management groups, laboratory and clinical investigators, management and outside collaborators. RRecruits, interviews, and screens TBICoE clinical research study volunteers, administers and obtains informed consent.Assists in the collection and analysis of data to evaluate volunteer eligibility for enrollment.May assist with TBI Program/Quality Improvement initiatives at their site.Assists in the collection, analysis and interpretation of laboratory and clinical data obtained during a medical evaluation, report significant values, findings and events that require prompt attention to clinical investigators.Assists with the documentation and reporting of adverse events, completes and reviews subject eligibility criteria, protocol compliance, omissions, and errors and submits these forms as required.Prepares and maintains written and electronic volunteer databases/logs.Performs data extraction and chart reviews of patients’ and/or research participant’s medical records or other relevant record/systems, as applicable.Ensures that research records are stored and secured properly, and that inventory and records are updated and properly maintained.Conducts data verification as indicated, documents, assists the investigator and protocol coordinator with questions, may transcribe and resolve queries of data on study forms (hardcopy and/or electronic).Prepares documents, under direction of project leads. Trains incoming staff on study procedures and SOPs.Assists with statistical analyses and descriptive data capture under direction of project leads.Works with the site senior clinical research director and other senior research leads for the collection, documentation and analysis of metrics to ensure a successful research program.