Serve as the organizational appointee for assigned MFM research projects, maintaining the relationship and oversight of study procedures. Initiation / implementation of the observational or clinical research projects assigned including: Maintenance of Investigator and Research Staff CVs, Licensure and Training Records, Drafting and updating the Informed Consent Form with CIRB Boilerplate, Completion of Institutional Review Board (IRB) modifications with supporting documentation.
Maintain oversight of designated research project study activities including performing the following functions: Subject recruitment, Consenting and Enrollment/Randomization, Perform study procedures/assessments in accordance with clinical trial guidelines, Complete Data Entry into Case Report Forms and Query Resolution, Process/Ship Specimens per trial requirements, Maintain Regulatory files including delegation logs, FDA form 1572, training logs and other trial documents in compliance with federal and local regulations, Process IRB amendments, annual renewals, closures, etc, Attend regular meetings with members of the project at partnering institutions and sponsors to report on study progress.
Maintain financial records including Accounts Receivable Report, Check remittance with back-up details and assist with the annual A-133 audit. Serve as a liaison between investigators, research staff, hospital staff, the IRB and sponsors. Maintain and utilize research's Clinical Trial Management System (CTMS). Maintain strict patient confidentiality including restricted access to clinical trial files. Attend and participate in research meetings and report on study progress. Perform other tasks as assigned by leadership. Comply with all SPUH policies, procedures, objectives, quality assurance, safety, environmental and infection controls.
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