Human Research Protection Analyst

Company: Houston Methodist
Location: Houston
Posted on: March 20, 2023

Job Description:

JOB SUMMARYAt Houston Methodist, the Human Research Protection (HRP) Analyst position is a regulatory compliance professional that supports the Human Research Protections Office (HRPO) and the Institutional Review Boards (IRB) and is responsible for the comprehensive analysis of clinical research protocols and associated submissions for completeness, consistency, and compliance with regulations, guidelines, and institutional policies in preparation for IRB review. In preparation for IRB designee or committee review, this position gathers additional data as necessary from researchers, study staff, and others and provides appropriate guidance to researchers and IRB members to ensure the protection of human subjects in research. This position uses the regulations and institutional policies as a guide, advising investigators and study teams of potential gaps in protocol submissions, including associated documents, and suggests solutions to facilitate research. In collaboration with Senior (Sr) HRP Analysts and the Office of Research Protections (ORP) leadership, the HRP Analyst position advises and provides input to HRP Coordinators and other research stakeholders on the interpretation of regulations and guidance from oversight authorities, compliance matters, and institutional processes. As needed, this position provides support to Sr HRP Analysts and ORP leadership in the management of the HM Business Practice Committee (BPC) and Conflict of Interest (COI) reviews.PRIMARY JOB RESPONSIBILITIESJob responsibilities labeled EF capture those duties that are essential functions of the job.PEOPLE - 20%

• In collaboration with Sr. HRP Analysts and ORP leadership, advises and provides input to HRP Coordinators and other research stakeholders on the interpretation of regulations and guidance from oversight authorities, compliance matters, and institutional processes in review/preparation of protocol submissions for IRB consideration. (EF)
• Clearly and effectively communicates with research stakeholders, including investigators, study teams, and ORP colleagues, in review/preparation of protocol submissions for IRB consideration. (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 - 30%
• Assists in the professional development of HRP Coordinators providing guidance on Human Research Protection Office (HRPO) processes and workflows, and regulatory requirements. (EF)
• Assists in the preparation of IRB meeting agendas, assisting IRB Chairs and other HRPO team members in management of IRB meetings, including providing guidance to the IRB on regulatory requirements. (EF)
• Assists in the preparation and review of meeting minutes and IRB correspondence, ensuring regulatory requirements, IRB determinations and controverted issues (when applicable) are accurately captured and documented accordingly. (EF)
• Participates in HM team projects, upon request. Assists other ORP team members in research-related priority projects, as needed. (EF)QUALITY/SAFETY - 35%
• Coordinates all aspects of human research proposal submission, review, and approval processes, and assures reviews are commensurate with applicable regulatory regulations and institutional policies. (EF)
• Conducts reviews of research applications, and associated documents, to ensure completeness, consistency, and accuracy in preparation for IRB review. (EF)
• Assists in making regulatory determinations to drive required ancillary committee and IRB reviews, when needed. Prepares succinct synopsis for all protocol submissions, highlighting any regulatory considerations or determinations the IRB must include in its review. (EF)
• Reviews official IRB correspondence drafted by HRP Coordinators to ensure IRB reviews are accurately captured. (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)
• Assist ORP leadership in human research protection (re)accreditation processes. (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 in Research Administration, Legal, Ethics, Policy, or related field preferredEXPERIENCE REQUIREMENTSo Three years of clinical research experience within an IRB/Human Research Protections Program (HRPP) or three years of direct regulatory oversight of clinical research ORMaster's degree with either one year of experience within an IRB/Human Research Protections Program (HRPP) or one year of direct regulatory oversight of clinical research

Keywords: Houston Methodist, Houston , Human Research Protection Analyst, Professions , Houston, Texas