Senior Research Protection Analyst - Human Research Protections / IRB - Military Veterans

JOB SUMMARY

At Houston Methodist, the Sr Human Research Protection (HRP) Analyst position is responsible for regulatory compliance that supports the Human Research Protections Office (HRPO) and the Institutional Review Boards (IRB). This position completes 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. The Sr. HRP Analyst position serves as a primary point of contact for research stakeholders as a subject-matter expert in support of the Human Research Protections Office (HRPO) and the IRB’s day-to-day operations. This position is solution-oriented and provides outstanding, consistent customer service and will mentor lower-level team members, including HRP Analysts and HRP Coordinators. The Sr. HRP Analyst position participates as needed in structured education and training sessions for research stakeholders and provides support to Office of Research Protections (ORP) leadership in the administrative management of the HM Business Practice Committee (BPC), including agenda management, scheduling meetings, and taking and preparing meeting minutes. The Sr. HRP Analyst position may also provide support in the management of Conflict of Interest (COI) reviews.

Please note that this position is a hybrid position for Texas residents only.

PRIMARY JOB RESPONSIBILITIES

Job responsibilities labeled EF capture those duties that are essential functions of the job.

PEOPLE - 25%

1. Serves as a team lead for HRP Analysts and HRP Coordinators, assisting in their professional development by providing guidance on HRPO processes and workflows, institutional policy and federal and state regulatory requirements. (EF)
2. Participates in educational workshops for individuals engaged in research at the institution. Assists institutional investigators, regulatory and other members of the research team by providing education and training regarding HRPO and IRB requirements. (EF)
3. Provides expert consultation and guidance to on an ongoing basis. Communicates with related regulatory committees and administrative departments to assure efficient completion of required reviews. Provides education and training in a structured manner to IRB members on an ongoing basis annually. (EF)
4. Role models’ healthy work relationships such as mitigation of conflict, leading problem-solving and resolution efforts. Provide outstanding, consistent customer service which includes written and verbal communication with stakeholders and colleagues. (EF)
5. Conducts self in a manner that is congruent with cultural diversity, equity, and inclusion principles. Initiates contributions towards improvement of department scores for employee engagement, i.e., peer-to-peer accountability. (EF)

SERVICE - 20%

1. Provides administrative support to the BPC administrator including scheduling meetings, meeting location arrangements, catering when applicable, and generation of meeting minutes. Serves as a project lead for department/institutional initiatives, upon request. (EF)
2. Reviews official IRB correspondence and minutes drafted by HRP Coordinators and HRP Analysts to ensure IRB reviews are accurately captured (EF)

QUALITY/SAFETY - 35%

1. Consistently evaluates process and workflow to ensure efficiency and compliance in the facilitation of research across the health system and communicates effectively with ORP leadership any gaps or areas for improvement. (EF)
2. Leads the administrative process in support of IRB review and determinations. Conducts thorough and complete regulatory review of IRB applications to assure completeness, consistency, and accuracy. Ensures accurate and timely processing, tracking, and filing of submissions and documentation of IRB actions. (EF)
3. Triages protocol submissions to determine the appropriateness of IRB review. Determines correct level of regulatory IRB review required based on HHS and FDA regulations. Provides IRB members with synopsis and regulatory guidance for all applications, from initial review through study closure. (EF)
4. Attends IRB meeting to serve as the regulatory subject matter expert, advising IRB Members and other HRPO team members in management of IRB meetings and adherence to regulatory requirements. (EF)

FINANCE - 10%

1. 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%

1. 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)
2. Assists leadership in human research protection (re)accreditation processes. (EF)
3. 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 REQUIREMENTS

o Bachelor’s degree or higher within a related field

o Master’s degree in Research Administration, Legal, Ethics, Policy, or related field preferred

EXPERIENCE REQUIREMENTS

o Five years of clinical research experience within an IRB/Human Research Protections Program (HRPP) or five years of direct regulatory oversight of clinical research OR

Master’s degree with either three years of experience within an IRB/Human Research Protections Program (HRPP) or three years of direct regulatory oversight of clinical research