Director, Research Integrity and Regulatory Affairs
Job Description:
Reporting to the AVP, Research Regulations & Compliance, the Director of the Office of Research Integrity and Regulatory Affairs provides oversight of the regulatory aspect of human clinical studies and services to ensure compliance. The Office for Research Integrity and Regulatory Affairs offers a variety of human research support services and education to the UTMB research community to assist and ensure investigators and their support staff are in compliance with federal, state and local laws and regulations as well as institutional policies. The Director has expert knowledge in regulatory issues. The Director has responsibility for coordinating the interaction between the various elements at the institution involved in the review, approval, and oversight of clinical research.
Scope: This position interacts with organizational units spanning Office of Clinical Research, Office of Human Research Protection Program, schools, departments, central UTMB administration, University of Texas System, and State and Federal agencies
Essential Job Functions:
- Establish new office and requisite services. Takes a leadership role in ensuring UTMB’s clinical research program has high quality and integrity in compliance with Federal, State regulations and University guidelines.
- Create policy and procedures in support of regulatory services, particularly in support of GCP.
- Ensure study consultation is provided at any point in the research to ensure regulatory compliance from protocol design to study closeout.
- Stays informed on guidelines related to clinical research and human subjects research and ensures that research is in compliance with appropriate federal and or state regulations and guidelines.
- Review and reconcile regulatory documents.
- Directs and develops the response to adverse events or allegations of noncompliance. Assist in prescribing corrective actions to ensure the protection of human subjects and compliance with regulation and policies.
- Develops and implements appropriate monitoring procedures for research involving human subjects.
- Develops training requirements and oversees training of faculty in conducting clinical research.
- Review of Study Design
- Manage Post Approval monitoring of clinical studies process.
- Manage the IRB pre-submission assistance process.
- Direct onsite review process of study documentation offering corrective actions and quality improvement recommendations.
- Support the creation of Study Management Tools for researchers
- Develop Standard Operating Procedures for clinical trials.
- Direct Post Approval Auditing of approved human research protocols
- Provide oversight of the development and submission of UTMB sponsored IND/IDE applications.
- Serves as the institutional contact to clarify questions of clinical research regulations and GCP. Responsible for efficient and compliant processes for post approval monitoring of approved by IRBs.
- Responsible for UTMB standing Data Safety Monitoring Board (DSMB). Provides advice and consultation to DSMB chairs, members and staff on ethical principles, laws, regulations, and policies regarding the review and conduct of clinical research.
- Monitors financial and business performance indicators against budgeted targets.
- Maintains appropriate documents and records.
- Responsible for professional development of staff; promotes education and cross-training in order to maximize staffing potential.
- Supports and interprets the purpose, philosophy, objectives, and operation of the Institution in order to assure the best service is available to the research/academic community.
- Adheres to internal controls and reporting structure.
- Performs related duties as assigned.
Minimum Qualifications:
- Bachelor’s degree
- Five plus years of experience with the interpretation and application of state and federal research regulations, in addition to implanting school/institution/organization-wide education, compliance/and or monitoring programs.
Preferred Qualifications:
- Advanced degree
Knowledge/Skills/Abilities:
- Business Acumen: Able to leverage personal skills to achieve high level results, specifically personal skills in financial management and planning, understanding of academic medical research environment, regulations and challenges, and ability to overcome barriers to timely and productive research.
- Collaboration Skills: Able to lead by example. Able to foster collaborative and constructive relationships with colleagues, faculty, and management of the university.
- Influencing Skills: Able to demonstrate expertise in a hands-on manner, able to demonstrate the value-added of their work.
- Fair and impartial advisor in the pursuit of organizational goals.
- A team player who works effectively in a complex, matrix organization.
- Exceptional organizational skills and a focus on results that ensures timely progress on execution priorities.
- Superior listening skills and a capacity to understand multiple needs and define “win/win” approaches to challenges and problem solving.
- A strong customer service focus.
- Exceptional professional and personal ethics.
Equal Employment Opportunity:
UTMB Health strives to provide equal opportunity employment without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, genetic information, disability, veteran status, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. As a VEVRAA Federal Contractor, UTMB Health takes affirmative action to hire and advance women, minorities, protected veterans and individuals with disabilities.
