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

• 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

• Under the direction of Research Integrity and Compliance management, prepares oral and/or written communication of audit commencement, objectives, status, and results to audit customers.

• Provides Research Integrity and Compliance management with periodic status reports regarding progress against the annual audit plan and other goals such as cycle time targets, issues identified, and barriers encountered.

• 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

• Under the direction of Research Integrity and Compliance management, conducts entry level healthcare, financial, compliance, and research operational internal audits.

• Displays a positive, helpful, and supportive attitude and demeanor with audit customers and maintains the department target customer satisfaction survey goal.

• Performs periodic follow-up of previously reported audit findings to assess resolution and corrective action taken.

QUALITY/SAFETY ESSENTIAL FUNCTIONS

• Applies current internal control frameworks for consistency in risk assessment and audit conduct. Ensures requirements to correct audit findings are completed.

• Ensures results are reported to applicable parties, up to and including the HMRI and System Business Practices Committees

• Works with Research Integrity and Compliance management to create concise and accurate written audit reports.

FINANCE ESSENTIAL FUNCTIONS

• Under the direction of Research Integrity and Compliance management, performs risk assessments and develops risk-based audit approaches and establishes the preliminary scope of reviews.

• Identifies and quantifies opportunities for improvement and works with Research Integrity and Compliance management to develop formal audit recommendations that are value-added and cost-effective.

• Utilizes time tracking reports to track audit completions. Maintains appropriate audit report cycle times and audit work paper documentation within established timelines in the appropriate audit system.

GROWTH/INNOVATION ESSENTIAL FUNCTIONS

• Develops and maintains competency in current research industry regulations and best practices through networking with other research audit leaders outside of the organization and through continuing education.

• Actively seeks knowledge of new, automated, or more contemporary audit tools and techniques to increase departmental efficiency and effectiveness.

• 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, preferably in Business, Accounting, or a scientific discipline

WORK EXPERIENCE

• Two years of internal or research auditing, healthcare operations, or research administration experience

LICENSES AND CERTIFICATIONS - REQUIRED

• N/A

LICENSES AND CERTIFICATIONS - PREFERRED

• Relevant certification or license. Example: RQAP - Registered Quality Assurance Professional OR
• CIA - Certified Internal Auditor (IIA) OR
• CHIAP - Certified Healthcare Internal Auditor (AIHC) OR
• CIP - Certified IRB Professional OR
• CPIA - Certified Professional in IACUC Administration (PRMR) OR
• CCRP - Certified Clinical Research Professional (SOCRA) OR
• CCRA - Certified Clinical Research Associate (ACRP) OR
• CHRC - Certified in Healthcare Research Compliance (HCCA) OR
• CHC - Certified Healthcare Compliance (HCCA)

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

• Demonstrates project management skills

• Ability to multi-task and perform audits within established timeframes

• Proficient in Microsoft Office Suite

• Strong verbal and written communications skills and the ability to interact through all levels of the organization

• Professional handling of exposure to confidential/sensitive information with confidentiality, honesty, and integrity

• Basic industry skills and ability to conduct audits including risk assessments, design of audit procedures, reporting, and follow-up processes for healthcare audit projects

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.