At Houston Methodist, the Office of Research Protections (ORP), Pre-Clinical Regulatory Analyst position is responsible for the comprehensive analysis of protocols and associated documentation submitted for IACUC review for completeness, consistency, and compliance with regulations, guidelines, and institutional policies. In preparation for IACUC review, the Pre-Clinical Regulatory Analyst will 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 animals in research. Using the regulations and institutional policies as a guide, the Pre-Clinical Regulatory Analyst advises investigators and study teams of potential gaps in protocol submissions, including associated documents, and suggests solutions to facilitate research. In collaboration with the Sr. Pre-Clinical Regulatory Analysts, the IACUC Manager and the ORP leadership, this position may also advise and provide input to other research stakeholders on the interpretation of regulations and guidance from oversight authorities, compliance matters, and institutional processes.

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.

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

• Displays cultural humility, diversity, equity and inclusion principles

• Actively supports the organization's vision, fulfills the mission and abides by the I CARE values

PEOPLE ESSENTIAL FUNCTIONS

• 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.

• 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.

• 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.

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 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.

• 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 follow-up of all regulatory and accreditation requirements.

FINANCE ESSENTIAL FUNCTIONS

• 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.

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 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.

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

• Bachelor's degree in related field or Master's degree in Research Administration, Legal, Ethics, Policy, Sciences, or related field

WORK EXPERIENCE

• Two years of 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

LICENSES AND CERTIFICATIONS - REQUIRED

• CPIA - Certified Professional in IACUC Administration (PRMR) -- to sit for the CPIA exam within 1 year AND
• Other research certificates encouraged

KNOWLEDGE, SKILLS, AND ABILITIES

• Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going 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 co-workers 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

ON-CALL*
*Note that employees may be required to be on-call 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

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 540,000 square foot building dedicated to research, the research institute houses over 1,500 staff and trainees, 284 principal investigators and has more than 570 ongoing clinical trials.