Supports clinical research projects by facilitating finalization on medical research protocols, managing final approvals of procedures, and assisting research faculty with future trials by study protocol drug and device advisement. Prepares, writes, and presents updated protocols. Works directly with patients and takes medical histories, performs exams, obtains biological specimens, assists with procedures, schedules tests, and performs study-specific protocols. Acts as liaison to regulatory bodies and reports to auditing bodies. Ensures regulatory adherence.

Supports clinical research projects by facilitating finalization on medical research protocols, managing final approvals of procedures, and assisting research faculty with future trials by study protocol drug and device advisement. Prepares, writes, and presents updated protocols. Works directly with patients and takes medical histories, performs exams, obtains biological specimens, assists with procedures, schedules tests, and performs study-specific protocols. Acts as liaison to regulatory bodies and reports to auditing bodies. Ensures regulatory adherence.

•Oversees review and finalization of all medical research protocols. Manages final approvals of procedural testing, imaging, and physical exams.

•Advises research faculty on study protocol drug and devise use. Assists research faculty in setting up future study trials.

•Collaborates across departments and with funding agencies in study protocol coordination.

•Assists in protocol development and implementation; serves as a resource for coordinators at other sites. Writes and presents protocols, revisions, and amendments for department and regulatory committees/bodies.

•Takes medical histories, screens patients, performs physical exams, obtains biological specimens, and assists with procedures. Obtains consent to participate, schedules, and coordinates tests. Performs study protocols including, but not limited to, administering oral study drugs, collecting blood samples, and ensuring appropriate test data is collected. Follows study patients and fosters effective relationships to limit losses.

•Educates the parent and/or participant regarding study product, medication, protocol procedures, treatments, and illness prevention. Triages parent telephone calls and provides consultation.

•Acts as liaison to federal and regulatory bodies; reports to auditing bodies.

•Ensures all protocol and regulatory standards are adhered to.