• Regulatory Associate (Research, Regulations…

    UTMB Health (Galveston, TX)


    Regulatory Associate (Research, Regulations and Compliance - Galveston)

     

    Galveston, Texas, United States

     

    New

     

    Research Academic & Clinical

     

    UTMB Health

     

    Requisition # 2505508

    Minimum Qualifications:

    Bachelor’s degree or equivalent and two years of related experience.

    Job Summary:

    Coordinates the daily activities associated with the processing of minimal risk research protocols and all facets of protocol review management to assist the Institutional Review Board. Additionally provides review, and analysis regarding changes to approved research protocols, adverse events and protocol deviations.

    Job Duties:

    + Administers expedited and exempt research review processes, including, but not limited to: intake of protocols and assessment of review level (with referral to full IRB, when applicable); regular one-on-one meetings with IRB Chairs for final determinations; drafting correspondence to investigators regarding IRB determinations.

    + Performs review analysis of study protocols, and identifies deficiencies, informed consent documents, response to stipulations, and other study-related documentation, to assure conformance with all applicable requirements.

    + Works under limited supervision to assure compliance with federal regulations relating to human subject research.

    + Works under limited supervision to assist management with business functions to assure compliance with federal regulations relating to human subject research.

    + Understands and applies multiple regulations to complex scientific research projects.

    + Understands and applies ethical principles and multiple regulations to complex scientific research projects.

    + Provides working supervision, training, and guidance to lower-level Regulatory Assistants. Assign tasks and set work priorities. Review work for accuracy.

    + Provides consultation and technical assistance to investigators and study personnel regarding requirements for IRB submissions, performance of studies, and documentation of compliance.

    + Serves as an information resource to the campus about human subject protection.

    + Analysis and development of updates to internal IRB guidance, office procedures/business processes, related forms, database improvements, and other quality assurance activities.

    + Attention to detail.

    + Ability to perform multiple duties simultaneously and to manage occasional increased workload volumes.

    + Ability to prioritize and process IRB submissions in an expeditious manner

    + Ability to engage in independent decision-making while also working as part of a team

    + Perform other duties as assigned.

    + Adheres to internal controls and reporting structure.

    MARGINAL OR PERIODIC JOB FUNCTIONS:

    + Performs related duties as required.

    Salary Range:

    Commensurate with experience.

    EQUAL EMPLOYMENT OPPORTUNITY:

    UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a Federal Contractor, UTMB Health takes affirmative action to hire and advance protected veterans and individuals with disabilities.

     

    Compensation