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    Analyst - Oklahoma City, United States - Creative Solutions Services, LLC

    Creative Solutions Services, LLC
    Creative Solutions Services, LLC Oklahoma City, United States

    3 weeks ago

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    Description
    Responsible for conducting in depth reviews of submissions to the Health Institutional Review Board using advanced regulatory knowledge.

    This includes the review of new protocols, continuing reviews, modifications to existing protocols, study closures, emergency use requests, exempt studies, expedited review and review of any Unanticipated Problems involving Risks to Subjects or Others.

    The role works closely with other IRB officers of administration to ensure uniformity of reviews and compliance with the Institutional Review Board (IRB) standard operating procedures as well as applicable federal and state regulations.

    This position is the system point of contact for IRB related processes and procedures and is responsible for vetting documents to the responsible party.

    This position works closely with the IRB Chair and members to provide education, meeting schedules, and agenda.

    Under the direction of the System Director of Research, this position is key in communicating new information related to the Protection of Human Subject in Research.

    This position serves as a liaison between the reviewer and investigator/study team.

    This position is responsible for the financial oversight of the IRB including invoicing of payments, tracking payments, tracking exempt payments, and reporting write offs related to community benefit.


    The Institutional Review Board Specialist responsibilities include, but are not limited to, the following: * Serves as the primary point of contact for all activities requiring review by the Institutional Review Board; performs preliminary reviews and recommends appropriate course of action.

    * Advises physicians and staff regarding instructions, policies and procedures, and electronic submission processes of applications through the IRB-Plus system.

    * Reviews all submissions for accuracy and compliance with the policies, provisions, and applicable regulations as required by IH, OHRP, DHHS, TJC, and FDA.

    * Collaborates with investigators to ensure accuracy of research document submission.

    * Coordinates aspects of the monthly convened IRB meetings including preparation and distribution of the meeting agenda and Administrative Review Reports.

    Attends the IRB Monthly Meeting and records the decision-making process of the IRB Board in official meeting minutes.

    * Apprises investigators and research team on the IRB decisions, approvals, changes, additional information, and similar issues and monitors the status of outstanding issues through resolution.

    * Maintains required documentation for IRB members and updates roster as needed. * Maintains the research subjects' enrollment database for tracking and coordination for billing purposes. * Maintains updated training and education requirements of Investigators, Sub-Investigators and Study Coordinators. * Prepares invoices for IRB services and tracks receipt of payments. *Works efficiently in all Microsoft Office Applications.

    Reports to the System Director or Vice President of Evidence Based Practice and Informatics This position may have additional or varied physical demand and/or respiratory fit test requirements.

    Please consult the Physical Demands Project SharePoint site or contact Risk Management/Employee Health for additional information. Normal office environment.

    All applicants will receive consideration regardless of membership in any protected status as defined by applicable state or federal law, including protected veteran or disability status.


    Job Qualifications:

    • Associate degree in Business Administration, Education or healthcare related field. Four years healthcare project management experience can be substituted for degree.
    • Certified IRB Professional (CIP) preferred.
    • Must be able to communicate effectively in English (verbal/written).
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