【正文】 training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log. Collects documents needed to initiate the study for submission to the sponsor (., FDA Forms 1572, CVs, etc.). Works with the PI to develop and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals. Conducts or participates in the informed consent process including interactions with the HRPO (IRB), discussions with research participants, including answering any questions related to the protocol. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed. Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion. Registers participants to the appropriate coordinating center (if multisite study). Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source. Coordinates participant tests and procedures. Collects data as required by the protocol. Assures timely pletion of Case Report Forms. Maintains study timelines. Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or WU Policy on Investigational Drug/Device Accountability. Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms, etc. Retains all study records in accordance with sponsor requirements and University policies and procedures. Maintains effective and ongoing munication with sponsor, research participants and PI during the course of the study. Assists PI in preparation and submission of any modifications to the scientific protocol in accordance with Federal regulations and University and sponsoring agency policies and procedures. Works with the PI to manage the day to day activities of the study including problem solving, munication and protocol management.Protected Health Information Adheres to and supports all Federal regulations and University policies and procedures instituted to safeguard protected health information (PHI). Completes the appropriate level of training regarding the access, use, and disclosure of PHI in accordance with Federal regulations and University and sponsoring agency policies and procedures. Assists PI to assure that all personnel plete appropriate training. Cooperates with University pliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of nonpliance to the appropriate pliance office.Unanticipated Problems Assists the Principal Investigator in promptly reporting any unanticipated problems involving risks to research participants or others to the HRPO (Washington University’s IRB). Reporting Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within Washington University’s Research Integrity Policy and other misconduct as described in Washington University’s Code of Conduct. Assists Principal Investigator with scientific and pliance reporting requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures. Assists in the registration (if required) of the study at and maintains current information on the site.Project Closeout Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, University entities, and the sponsoring agency in accordance with Federal regulations and University and sponsoring agency policies and procedures. Arranges secure storage of study documents that will be maintained according to University policy or for the contracted length of time, whichever is longer.Environmental Health and SafetyGeneral Administrative Assists Principal Investigator in assuring that individuals handling hazardous or regulated materials are well trained in proper safety procedures and have pleted required environmental health and safety training in accordance with Federal, State, and local regulations and University and sponsoring agency policies and procedures. Works with Environmental Health and Safety to ensure that all facilities used are in pliance with all applicable regulations. Maintains copies of any applicable facility audits and equipment inspection/service reports.Human Gene TransferGeneral Administrative Assists Principal Investigator in protection of the rights and welfare of all human research participants involved in research in accordance with Federal regulations and University and sponsoring agency policies and procedures. Assists Principal Investigator in assuring that all key personnel involved in human research have pleted the required education for the protection of human research participants in accordance with Federal regulations and University and sponsoring agency policies and procedures. Maintains proof of all such education for all engaged members of the study team. Coordinates with Principal Investigator and school, department, and central administration to help ensure that clinical research and related activities are performed in accordance with Federal regulations and University and sponsoring agency policies and procedures. Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentat