Pre-Clinical Regulatory Analyst (IACUC)
Pre-Clinical Regulatory Analyst (IACUC)
Posted on :
06-05-2025
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1 Vacancy
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Job Description
Overview
At Houston Methodist the Office of Research Protections (ORP) PreClinical Regulatory Analyst position is responsible for the comprehensive analysis of Institutional Animal Care and Use Committee (IACUC) protocols and associated documentation for completeness consistency and compliance with regulations guidelines and institutional policies. This customer service focused position provides appropriate guidance to researchers and committee members to ensure compliance and animal welfare. In preparation for IACUC review the PreClinical Regulatory Analyst gathers additional data as necessary from researchers study staff and others. Using the regulations and institutional policies as a guide the PreClinical Regulatory Analyst advises investigators and study teams of potential gaps in protocol submissions including associated documents and suggests solutions to facilitate their research goals.
In collaboration with Sr. PreClinical Regulatory Analysts the IACUC Manager and the ORP leadership this position may advise and provide input to other key stakeholders on the interpretation of regulations and guidance from oversight authorities compliance matters and institutional processes.
In collaboration with Sr. PreClinical Regulatory Analysts the IACUC Manager and the ORP leadership this position may advise and provide input to other key stakeholders on the interpretation of regulations and guidance from oversight authorities compliance matters and institutional processes.
Houston Methodist Standard
PATIENT AGE GROUP(S) AND POPULATION(S) SERVED
Refer to departmental Scope of Service and Provision of Care plans as applicable for description of primary age groups and populations served by this job for the respective HM entity.
Refer to departmental Scope of Service and Provision of Care plans as applicable for description of primary age groups and populations served by this job for the respective HM entity.
HOUSTON METHODIST EXPERIENCE EXPECTATIONS
- Provide personalized care and service by consistently demonstrating our I CARE values:
- INTEGRITY: We are honest and ethical in all we say and do.
- COMPASSION: We embrace the whole person including emotional ethical physical and spiritual needs.
- ACCOUNTABILITY: We hold ourselves accountable for all our actions.
- RESPECT: We treat every individual as a person of worth dignity and value.
- EXCELLENCE: We strive to be the best at what we do and a model for others to emulate.
- Practices the Caring and Serving Model
- Delivers personalized service using HM Service Standards
- Provides for exceptional patient/customer experiences by following our Standards of Practice of always using Positive Language (AIDET Managing Up Key Words)
- Intentionally collaborates with other healthcare professionals involved in patients/customers or employees experiential journeys to ensure strong communication ease of access to information and a seamless experience
- Involves patients (customers) in shift/handoff reports by enabling their participation in their plan of care as applicable to the given job
- Actively supports the organizations vision fulfills the mission and abides by the I CARE values
Responsibilities
PEOPLE ESSENTIAL FUNCTIONS
SERVICE ESSENTIAL FUNCTIONS
QUALITY/SAFETY ESSENTIAL FUNCTIONS
FINANCE ESSENTIAL FUNCTIONS
GROWTH/INNOVATION ESSENTIAL FUNCTIONS
This job description is not intended to be allinclusive; 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.
- Advises and provides input to Principal 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.
- 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.
- Contributes towards improvement of department scores for employee engagement i.e. peertopeer accountability.
SERVICE ESSENTIAL FUNCTIONS
- 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.
- 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.
- Creates educational and training materials for Research Protections training committee member education and Open House sessions.
QUALITY/SAFETY ESSENTIAL FUNCTIONS
- Coordinates all aspects of research proposal submission review and approval processes and ensures 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.
- 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.
- Assists in the development of Office of Research Protection (ORP) processes and workflows to support regulatory and institutional requirements.
- Assists ORP management in the planning implementation and followup of all regulatory and accreditation requirements.
FINANCE ESSENTIAL FUNCTIONS
- Utilizes resources with cost effectiveness and value creation in mind. Selfmotivated to independently manage time effectively and prioritize daily tasks assisting coworkers as needed.
GROWTH/INNOVATION ESSENTIAL FUNCTIONS
- Identifies areas of the ORP/Committee review processes that require improvement or streamlining in order to facilitate research.
- 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.
- Assists in research protection (re)accreditation processes.
- Seeks opportunities to identify selfdevelopment needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an ongoing basis.
This job description is not intended to be allinclusive; 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.
Qualifications
EDUCATION
WORK EXPERIENCE
- Bachelors degree in related field or Masters degree in Research Administration Legal Ethics Policy Sciences or related field
WORK EXPERIENCE
- Bachelors degree with two years of research experience within an IACUC Research Protections Program or two years of direct regulatory oversight of animal research or two years of experience within lab animal research setting
- Masters degree with one year of experience within an IACUC Research Protections Program or one year of direct regulatory oversight of animal research or one year of experience within a lab animal research setting
License/Certification
LICENSES AND CERTIFICATIONS REQUIRED
- CPIA Certified Professional in IACUC Administration (PRMR) With 1 year of eligibility to sit for the exam within 1 year
KSA/ Supplemental Data
KNOWLEDGE SKILLS AND ABILITIES
- Demonstrates the skills and competencies necessary to safely perform the assigned job determined through ongoing skills competency assessments and performance evaluations
- Sufficient proficiency in speaking reading and writing the English language necessary to perform the essential functions of this job especially with regard to activities impacting patient or employee safety or security
- Ability to effectively communicate with patients physicians family members and coworkers in a manner consistent with a customer service focus and application of positive language principles
- Must have ability to rapidly acquire and implement knowledge of related regulations and ethical principles
- Exercises independent judgment related to situations of a sensitive confidential and scientific nature
SUPPLEMENTAL REQUIREMENTS
WORK ATTIRE
- Uniform No
- Scrubs No
- Business professional Yes
- Other (department approved) No
ONCALL*
*Note that employees may be required to be oncall during emergencies (ie. DIsaster Severe Weather Events etc) regardless of selection below.
- On Call* No
TRAVEL**
**Travel specifications may vary by department**
- May require travel within the Houston Metropolitan area Yes
- May require travel outside Houston Metropolitan area Yes
Company Profile
Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics therapies and treatments. The research institute was created to provide the infrastructure and support for these endeavors and to house the technology and resources needed to make innovative breakthroughs in important areas of human disease. A 540000 square foot building dedicated to research the research institute houses over 1500 staff and trainees 284 principal investigators and has more than 570 ongoing clinical trials.
Required Experience:
IC
Employment Type
Full-Time
Key Skills
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