The University of Texas at Austin Job Posting

This posting is Closed

Associate Director - Associate Director, Research Quality and Regulatory Affairs

Hiring department Medical School
Monthly salary $9,166+ depending on qualifications
Hours per week 40.00 Standard from 800AM to 500PM
Posting number 18-01-03-01-0385
Job Status Closed
FLSA status Exempt
Earliest Start Date Immediately
Position Duration Funding expected to continue
Position open to all applicants
Location Austin (main campus)
Number of vacancies 1
General Notes

None provided

Required Application Materials

  • A Resume is required in order to apply
  • A Letter of Interest is required in order to apply.
  • A List of 3 References is required in order to apply.

Additional Information


In collaboration with the Dell Medical School Chief Research Officer, facilitate the Dell Medical School investigators' use of best research practices to comply with all federal and state regulations, guidelines, laws, and local and institutional policies and procedures governing the conduct of research.

Essential Functions

Provide oversight and act as the subject matter expert for the school regarding the interpretation, implementation and compliance with policies and regulations. Suggest approaches for complex issues regarding adherence or compliance. Represent the school on topics, issues, and/or initiatives involving research compliance at the university or system level or to external constituencies. Identify, develop and maintain research polices necessary to ensure adherence to research regulations. Provide consultation and training to individual investigators or research teams on design and evaluation of research protocols and procedures with regards to regulatory concerns. Identify research projects that would benefit from consultation. Develop and deliver training; collect, summarize, and develop informational or guidance related documentation; and coordinate and maintain high level communications - to ensure that regulatory guidelines are understood. Work closely with research study investigators and staff to determine education and training needs for best practices in research. Assist clinical investigators in performing coverage analysis, advise on appropriate clinical research billing procedures, and sign-off on all billing plans for studies occurring at a Dell Medical School facility or UT Health Austin Clinic. Inform appropriate school or institutional officials of practice deficiencies, provide metrics as requested, recommend necessary corrective actions, and monitor to ensure that deficiencies are corrected. Design and implement strategies for enhancing compliance with research policies. Provide support to investigators and research teams, and will adopt a collaborative, team-based approach to ensuring compliance. Assist, as needed, with clinical trials registration and disclosure and ensure compliance with such requirements. Utilize to provide metrics on Dell Medical School faculty involvement in clinical trials research. Liaison with UT Health Austin billing team and clinical research teams to facilitate the reimbursement for clinical procedures from research study sponsors. Draft internal Standard Operating Procedures (SOPs) for monitoring research compliance and promoting research integrity. Directly manage one or more team members.

Marginal/Incidental functions

Other related functions as assigned.

Required qualifications

Bachelor's degree and at least 10 years of related experience demonstrating expert knowledge in federal and state laws, regulations, and guidance relating to research and related areas, including at least 5 years in human subjects research and 3 years of clinical research experience. Experience in a leadership or supervisory position involving the management of research staff. Experience in conducting review audits and experience with FDA and GCP compliance. Strong communication skills, both oral and written. Excellent interpersonal skills, ability to interact in a positive and productive manner with a wide-variety of stakeholders - researchers, staff, academic administrators, clinical leadership, regulatory officials, and auditors - while demonstrating sensitivity, tact, and professionalism. Sufficient professional experience, adequate education, and sound judgement to comprehend, interpret, and analyze publications and reports concerning applicable policies, procedures, and regulations. Proficiency with electronic systems and software. Ability to identify, organize, and prioritize work independently, while working in a team environment. Equivalent combination of relevant education and experience may be substituted as appropriate.

Preferred Qualifications

Advanced degree or additional emphasis/training/education in bioethics, health law, health profession, or a related scientific discipline. Certified Clinical Research Professional (CCRP). The Dell Medical School is especially interested in qualified candidates who can contribute to diversity and excellence within the learning health system. At the Dell Medical School we strive to create a vital, inclusive health ecosystem. To ensure alignment, we follow these fundamental values:

Working conditions

May work around standard office conditions Repetitive use of a keyboard at a workstation

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