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
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