Assistant Director Clinical Research OCR

University Of Texas Southwestern Medical Center   •  

Dallas, TX

Industry: Hospitals & Medical Centers


11 - 15 years

Posted 48 days ago

Experience and Education

Master's degree in public health, business administration, or health administration with a minimum of ten (10) years' progressively responsible related experience a minimum of five (5) years supervisory experience with a large externally funded academic center or institutional research infrastructure.

Documented experience with grant submission, preparation and submission of regulatory documents, working with regulatory agencies. Direct experience with selection and implementation of a clinical trial management system integrated to Epic In-depth knowledge of Epic research functionality, research-billing compliance and functionality of clinical trial management system. Documented experience with creation, implementation, and on-going operations with Community Outreach/Engagement efforts. Preference will be given to individuals who are currently actively involved in preparation of NIH RFAs for clinical research infrastructure and/or review of NIH infrastructure grant proposals.

Job Duties

Within the Office of Clinical Research, this position is responsible for providing administrative oversight, guidance and leadership to personnel functioning in clinical/translational research at UTSW and affiliated institutions. This role will provide strategic leadership in support of the integration of clinical/translational research related activities at UTSW and affiliated institutions, incorporation of the clinical research faculty leadership into the administrative decision-making processes for research at UTSW, and establishment of an optimal clinical research alignment between research personnel, clinical research faculty at UTSW, and performing facilities. The Assistant Director of Research Administration will work with the manager of the Office of Clinical Trial Management (OCTM) to define and implement best practices related to clinical trial oversight and operational and budgetary and billing compliance; the Office of Clinical Research Personnel (OCRP) to oversee the development and implementation of the core curriculum, establish and document competencies, develop a mentorship/proctoring program for research personnel, serve as a consultant to research staff and faculty researchers to ensure efficient and compliant research activities, and manage the pool of research personnel who will serve as a shared resource for UTSW faculty conducting clinical research. Responsibilities also include directing, organizing, leading and supporting the operational, financial, and administrative functions related to clinical/translational research activities.

  • Collaborates with key stakeholders to establish organizational objectives, develop organizational long-range and strategic plans, and identify organizational strengths and weaknesses in addition to business opportunities.
  • Lead cross-functional projects and initiatives, operational effectiveness, capacity utilization, and operating cost containment.
  • Collaborate with stakeholders to identify and remove impediments to increase the efficiency and impact of research.
  • Establishes key operational metrics, publishes periodic performance reports to research community, maintains maximum efficiency and meets performance objectives. Leads continuous process and operational improvement initiatives to reduce cycle-times, improve overall compliance posture, and remove unnecessary administrative burdens.
  • Devise business plans to cost-effectively enhance and build clinical research infrastructure and service offerings and explores opportunities to expand UTSW's reach and increase engagement and collaboration with UTSW and non-UTSW performing sites.
  • Leads and manages special projects, including infrastructure grants and endowments.
  • Responsible for data collection, analyses, interpretation, and preparation of communicationswritten reports, executive briefings, and presentationsto inform UTSW leadership as well as leadership of UTSW Dean's Office, Health System, and the National Institutes of Health
  • Leads the day-to-day operations of clinical research infrastructure. In collaboration with SPA and Academic and Business Affairs manage the fiscal, personnel, operational, and administrative activities of the supportive clinical research infrastructure.
  • Monitors and evaluates operations, recommending and implementing changes in activities that affect program quality, service provision, and a positive culture. Initiates, develops, and implements regulatory standards for the institute and aids in the administration and oversight of the NIH infrastructure grants and other supplemental or affiliated extramural funding.
  • Serves as a liaison with the Office of Sponsored Programs Administrations, the Conflict of Interest Office, IRB/HRPP, UTSW departments and centers, and UTSW Health System and affiliated hospitals.
  • Implements and oversees an on-going educational and training program for faculty and staff relating to conducting research involving human participants in partnership with Office of Clinical Research Facilitation and the Center for Translational Medicine.
  • Handles proprietary and confidential information and matters with appropriate discretion and confidentiality.
  • Ensures the office will provide knowledgeable, friendly, professional and timely support to research community.
  • Oversees budget expenditures and scheduling. Oversees supervisors and/or subordinate managers, to include establishing priorities and staff training.
  • Performs other duties as assigned.

Knowledge, Skills & Abilities

  • Work requires the ability to maintain effectiveness when experiencing major changes in work responsibilities or environment; adjust effectively to work within new work structures, processes, requirements, or cultures.
  • Work requires deep knowledge base and experience with clinical research providing confidence in interfacing with faculty investigators of different seniority and experience.
  • Work requires patient-centric approach to clinical research.
  • Work values accountability, open communication, flexibility, and humor.
  • Work requires comfortability addressing large groups of people.
  • Work requires being articulate.