IBC Analyst / Safety Committee Analyst - Military Veterans

JOB SUMMARY

At Houston Methodist, the Research Protections, IBC Analyst / Safety Committee Analyst -Clinical Regulatory Analyst position is responsible for the comprehensive analysis of pre-clinical research protocols, and associated submissions for completeness, consistency, and compliance with regulations, guidelines, and institutional policies. In preparation for Institutional Animal Care and Use Committee (IACUC), Hazardous Substance Committee (HSC), Institutional Biosafety Committee (IBC), and Radiation Safety Committee (RSC) designee or committee review, gather additional data as necessary from researchers, study staff, and others. This position provides appropriate guidance to researchers and committee members to ensure the protection of subjects in research, patients, and the environment; Using the regulations and institutional policies as a guide, the Research Protections, Pre-Clinical Regulatory Analyst position advises investigators and study teams of potential gaps in protocol submissions, including associated documents, and suggests solutions to facilitate research. In collaboration with Research Protections, Sr. Regulatory Analysts, and the Office of Research Protections (ORP) leadership, this position advises and provides input to Research Protections, Regulatory Coordinators, and other research stakeholders on the interpretation of regulations and guidance from oversight authorities, compliance matters, and institutional processes. As needed, the Research Protections, Pre-Clinical Regulatory Analyst position provides support to Research Protections, Sr. Regulatory Analysts and ORP leadership in the management of the HM Business Practice Committee and Conflict of Interest reviews.

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

PRIMARY JOB RESPONSIBILITIES

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

PEOPLE - 20%

1. Advises and provides input to Principle Investigators (PI) 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 committee consideration. (EF)
2. Clearly and efficiently communicates with research stakeholders including investigators, study teams, committee members, and ORP colleagues, in review/preparation of protocol submissions for committee consideration. (EF)
3. 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%

1. Prepares committee meeting agendas. Assists Committee Chairs and other ORP team members in management of committee meetings, including providing guidance to the members on regulatory requirements. (EF)
2. Prepares and reviews meeting minutes and meeting correspondence, ensuring regulatory requirements, committee determinations and controverted issues (when applicable) are accurately captured and documented accordingly. Assists in preparation and review of official committee correspondence after committee reviews are complete. (EF)
3. Creates educational and training materials for Research Protections training, committee member education, and Open House sessions. (EF)

QUALITY/SAFETY - 40%

1. Coordinates all aspects of research proposal submission, review, and approval processes, and assures reviews are commensurate with applicable regulatory regulations and institutional policies. Conducts reviews of research applications, and associated documents, to ensure completeness, consistency, and accuracy in preparation for committee review. (EF)
2. Makes regulatory recommendations to drive required ancillary committee and regulatory committee reviews. Prepares succinct synopsis for all protocol submissions, highlighting any regulatory considerations or determinations the committee must include in its review. (EF)
3. Assists in the development of Office of Research Protection (ORP) processes and workflows, to support regulatory and institutional requirements. (EF)
4. Assists ORP management in the planning, implementation, and follow-up of all regulatory and accreditation requirements. (EF)

FINANCE - 5%

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 - 15%

1. Identifies areas of the ORP/Committee review processes that require improvement or streamlining in order to facilitate research. (EF)
2. Works in the electronic research administration platform(s) to ensure all appropriate regulatory correspondence is captured. Suggests improvements to the research administration platform(s) to ensure compliance, test programming upgrades. (EF)
3. Assists in research protection (re)accreditation processes. (EF)
4. 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 in related field or Master’s degree in Research Administration, Legal, Ethics, Policy, Sciences, or related field

EXPERIENCE REQUIREMENTS

o Two years of pre-clinical research experience within an IACUC or IBC or RSC Research Protections Program or two years of direct regulatory oversight of research with a Bachelor’s degree OR one year of experience within an IACUC or IBC or RSC Research Protections Program or one year of direct regulatory oversight of l research with a Master’s degree