At Houston Methodist, the Research Auditor position is responsible for the development, coordination, and execution of program(s) involving the review of research policies, processes and research-related activities of Houston Methodist faculty, staff, trainees, core services, and oversight committees under the direction of the Director, Research Integrity and Compliance. This position reviews the organization's operations, including the adequacy of internal controls, compliance with laws, regulations, International Council for Harmonization/Good Clinical Practice (ICH/GCP) and accreditation requirements, adherence to policy and procedures, the accuracy of reported research and research-related financial activities, and the well-being of those serving as subjects in research. The Research Auditor position is responsible for the formulation of risk assessments/matrices for management consideration and the conduct of Monitoring Assessment and Plan (MAP) reports as needed. Conducts targeted assessments as a service to the Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), and institutional safety committees. This position supports accreditation site visit preparation and recommends and assists in the implementation of associated Corrective Action and Management Plans (CAPAs) in any of the abovementioned areas.
The ideal candidate for this position will have significant experience in pre-clinical research endeavors, especially in the regulatory aspects of research conducted under IACUC and Safety Committee approvals, procedural training, and/or hands-on expertise in such research. Familiarity with research data management requirements is also beneficial.
Additional Preferences:
Hands’ on animal research experience or animal research administration experience is preferred
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
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 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
WORK EXPERIENCE
LICENSES AND CERTIFICATIONS - REQUIRED
LICENSES AND CERTIFICATIONS - PREFERRED
KNOWLEDGE, SKILLS, AND ABILITIES
SUPPLEMENTAL REQUIREMENTS
WORK ATTIRE
ON-CALL*
*Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.
TRAVEL**
**Travel specifications may vary by department**
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.
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