Fulfills the job responsibilities of the Oncology Research Specialist, and:Coordinates clinical and regulatory document submissions for clinical trial start-up, consent development and amendment, protocol amendment, continuing review, closure to accrual, action letter, suspension, termination and other reportable regulatory information. Assesses patient eligibility through chart reviews and patient/family interviews. Assists in providing patient education regarding the nature of their disease and the benefits/risks of participating in a clinical drug trial. Collaborates with regulatory team, Principal Investigator, Sub-Investigators, study personnel, IRB, sponsor/ CRO/monitor and other internal/external customers; coordinates documentation/submissions. Conducts routine NCI research base/sponsor website reviews to identify regulatory updates and actions required. Presents and obtains patient informed consent. Coordinates accurate data collection and record keeping by reviewing documents and processes for quality assurance and ensures timely and accurate submission of data. Coordinates and prepares for internal and external audits. Participates in sponsor study start-up and follow-up meetings as appropriate. Develops study calendars. Collaborates on billing and financial activity with Research Finance (budgets and billing compliance). Coordinates scheduling of patient visits, labs, and diagnostic procedures. Coordinates drug shipments, storage, and accountability with IDS/ Pharmacy. Assists in the development, improvement and review of Standard Operating Procedures and processes. Provides educational and technical assistance to research staff including orientation and mentoring of new research teammates.