Associate Director - Associate Director, Research Quality and Regulatory Affairs
Dell Medical School-The University of Texas at Austin
January 11, 2018
Starting at 109992.00
Full Time - Experienced
Hospital, Public and Private
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.
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 ClincialTrials.gov 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.
Other related functions as assigned.
May work around standard office conditions Repetitive use of a keyboard at a workstation
A criminal history background check will be required for finalist(s) under consideration for this position.
The retirement plan for this position is Teacher Retirement System of Texas (TRS), subject to the position being at least 20 hours per week and at least 135 days in length.
The University of Texas at Austin, as an equal opportunity/affirmative action employer, complies with all applicable federal and state laws regarding nondiscrimination and affirmative action. The University is committed to a policy of equal opportunity for all persons and does not discriminate on the basis of race, color, national origin, age, marital status, sex, sexual orientation, gender identity, gender expression, disability, religion, or veteran status in employment, educational programs and activities, and admissions.
If hired, you will be required to complete the federal Employment Eligibility Verification form, I-9. You will be required to present acceptable, original documents to prove your identity and authorization to work in the United States. Information from the documents will be submitted to the federal E-Verify system for verification. Documents must be presented no later than the third day of employment. Failure to do so will result in dismissal.
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.
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: https://dellmed.utexas.edu/culture.
About Dell Medical School-The University of Texas at Austin
The University of Texas at Austin was founded in 1883 by the Texas State Constitution and was the result of a mandate to establish “a university of the first class.” UT Austin is now one of the largest and most respected research universities in the world. It is a diverse learning community with more than 51,000 students hailing from every state and more than 100 countries. Dell Medical School at ...The University of Texas at Austin is the newest of 18 colleges and schools on campus.
Since the university’s inception in 1883, medical education was part of the plan to build a university of the first class. Owing to political maneuvering, though, the medical branch of the university was located in Galveston, a booming port city prior to 1900.
For 125 years, the idea for medical education in Austin continued to germinate. In 2008, UT Southwestern Medical Center in Dallas approved preliminary plans to locate a regional campus in the city, developing projections to test the financial feasibility of starting a modest-size, high-quality, research-oriented medical school in Austin. By fall 2009, UT Southwestern had signed an affiliation agreement with Ascension’s Seton Healthcare Family to partner in providing graduate medical education (GME) and pursue a vision of developing a medical school in Austin that would provide undergraduate medical education, GME and clinical research.
In late 2011, State Sen. Kirk Watson (D-Austin) created a list of 10 health-care centered goals he hoped to achieve within 10 years for his Central Texas district. No. 1 on that list was to build a medical school. Watson quickly created alignment with these goals from multiple constituencies, beginning with The University of Texas System Board of Regents. In May 2012, the Board of Regents allocated $25 million of annual funding to a UT Austin medical school, plus another $40 million over eight years for faculty recruiting. In November 2012, Travis County voters approved a proposition to raise property tax revenue in support of health care initiatives for Central Texas, including $35 million annually for a medical school. And in 2013, the Michael and Susan Dell Foundation pledged $50 million over 10 years to the school, which was named the Dell Medical School.
With significant funding sources secured, the UT System Board of Regents approved a plan in May 2013 to construct research, educational and administrative facilities, as well as a medical office building and parking garage on UT Austin property. Seton Healthcare Family and Central Health also confirmed plans to build a new teaching hospital on leased university land in the heart of the burgeoning health district. Construction of the facilities began in April 2014 and the Health Learning Building was completed in time to welcome the medical school’s first class in June 2016. Dell Seton Medical Center at The University of Texas, the new teaching hospital, opened in May 2017.
In January 2014, UT Austin named S. Claiborne “Clay” Johnston, MD, PhD, inaugural dean of the Dell Medical School, the first medical school in nearly 50 years to be built from the ground up at a top tier Association of American Universities (AAU) research university.