Research Protection Analyst-HRPP

Company: Houston Methodist
Location: Houston
Posted on: May 16, 2022

Job Description:

JOB SUMMARYAt Houston Methodist, the Research Protection Analyst position is responsible for comprehensive analysis of human research studies for compliance with regulations, guidelines, and institutional policies for the Institutional Review Board (IRB) which includes the review of submissions for completeness and compliance with Houston Methodist Research Institute (HMRI) policy and Federal regulations. This position gathers additional data as necessary from researchers, study staff, and others and provides education and training to researchers and IRB members. The Research Protection Analyst position advises researchers of submission problems and suggest solutions, providing input to IRB Chair and other stakeholders regarding regulation rules and intent, compliance and regulatory limits. This position may also be responsible for Business Practice Committee (BPC) management and Conflict of Interest (COI) review.PRIMARY JOB RESPONSIBILITIESJob responsibilities labeled EF capture those duties that are essential functions of the job.PEOPLE - 20%

• Assists institutional investigators, regulatory and other members of the research team by providing education and training regarding IRB and/or COI requirements and the electronic submission process. Training may be ad hoc, or face-to-face sessions with the entire research team. (EF)
• Communicates with related regulatory committees and administrative departments to assure efficient completion of required reviews, as well as communicating IRB requirements to the research team in writing and in person to assure understanding and appropriate response. (EF)
• Conducts self in a manner that is congruent with cultural diversity, equity and inclusion principles. Contributes towards improvement of department scores for employee engagement, i.e. peer-to-peer accountability. (EF)SERVICE - 20%
• Serves as Business Practice Committee (BPC) analyst to coordinate business practice meetings, set meeting calendar and arrange room and catering, record minutes. Prepares meeting agendas and assures quorum, along with drafting official IRB correspondence and IRB minutes. (EF)
• Assists other Research Protection staff as needed, including Quality Assurance, IBC, RSC, and HSC. Participates in Houston Methodist projects, where applicable. (EF)QUALITY/SAFETY - 45%
• Coordinates all aspects of human research proposal submission, review, and approval process and assures reviews are commensurate with funding agency and regulatory applicable regulations. (EF)
• Conducts initial review of IRB applications to assure completeness, consistency and accuracy. Reviews the protocol, informed consent and electronic application. (EF)
• Makes an initial determination for required review, whether an application requires IRB review and what type of review is required. Provides IRB Chairs with synopsis and initial review for all applications including initial application, continuing reviews, reportable events and amendments. Responsible for review and correspondence for administrative (minor, minimal risk) amendments. (EF)
• Reviews responses to IRB reviews assuring that the response meets the IRB's concerns prior to forwarding the application to the reviewer or placing it on the agenda. (EF)
• Reviews requirements for other committees, conflict of interest and credentialing prior to final approval. (EF)
• Primary responsibility for review of COI reports, as assigned. Serves as COI analyst and contact person for the department's COI related questions and issues. Coordinates the
• annual certification process for COI disclosures. Assists with reviewing procedures governing the disclosure, review, and management of COI. (EF)FINANCE - 5%
• Utilizes resources with cost effectiveness and value creation in mind. Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as needed. (EF)GROWTH/INNOVATION - 10%
• Identifies areas of the review process that require improvement, or that could be made more efficient and effective. Works with the electronic submission team to resolve problems, suggest improvements and test programming upgrades. (EF)
• Assists Director with achieving and maintaining human research protection accreditation. (EF)
• Seeks opportunities to identify self-development needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an on-going basis. (EF)This job description is not intended to be all inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.EDUCATION REQUIREMENTSo Bachelor's degree within a related fieldo Master's degree preferredEXPERIENCE REQUIREMENTSo Three years' clinical research experience or six months of related clinical research experience if Master's degree

Keywords: Houston Methodist, Houston , Research Protection Analyst-HRPP, Professions , Houston, Texas