Experience

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  Uthscsa

  Nov 2003 - Feb 2016

  -Assist Director with regulatory and compliance oversight of all research involving human subjects.-Ensure institutional compliance with international, federal, and state regulations regarding the conduct of research involving human subjects and fosters a culture of responsible conduct of research.-Develop and modify policies and operational processes to ensure compliance and to increase efficiency and quality-Serve as the regulatory specialist of the Institutional Review Board-Review complicated scientific research documents and identify substantive ethical and regulatory issues.-Provide education and training to faculty, study staff, IRB Office staff and Board members related to human subjects' protection regulations and the protocol review process.-Develop and distribute resource materials in an effort to improve protections for research subjects.-Review and approve protocol submissions (initial submissions, modifications and continuing reviews) which are eligible for expedited review or forward to full board for determinations.-Provide guidance to IRB staff, board members/chairs and researchers on resolving complex and controversial issues.-Solve, recommend and implement solutions for customer and affiliated inter-institution processes and procedures related to protocol submissions and the IRB review process.-Summarize the decision making process in applicable reviewer checklists, database and correspondence.-Collaborate with officials from affiliated institutions with regard to the review process and keep current on changes to regulations and consider implications for institutional review processes.-Provide direct supervision to four employees and indirect supervision to 10 additional.-Management duties include interviewing, selecting/training employees, planning/directing work, appraising productivity and efficiency.-Respond to follow-up inquires by federal agencies, faculty, and officials from affiliated institutions. Show less -Provide expert-level knowledge of federal (DHHS, FDA, VA and HIPAA), state regulations and policies, and institutional policies relevant to human research and privacy. These include research-related policies of UTHSCSA and other institutions covered by UTHSCSA IRBs-Review complicated scientific research documents and identify substantive ethical and regulatory issues as well as institutional policy issues such as those related to privacy and financial reimbursement for research participation. Communicate concerns to research study staff with the goal of resolving pertinent issues either by correcting issues or forwarding submission to full board-Review and approve protocol submissions (initial submissions, modifications and continuing reviews) eligible for expedited review or forward to full board for determinations-Provide guidance to IRB staff, board members/chairs and researchers on resolving complex and controversial issues-Solve, recommend and implements solutions for customer and affiliated inter-institution processes and procedures related to protocol submissions and the IRB review process-Summarize the decision making process in applicable reviewer checklists, database and correspondence-Capture and document controverted ethical and scientific issues identified during the review process -Assisted with preparing the IRB for AAHRPP re-accreditation process which includes developing and modifying policies and operational processes -Collaborate with officials from affiliated institutions -Provide education and training-Provide direct supervision to three employees and indirect supervision to 9 additional employees-Respond to follow-up inquires by federal agencies, faculty, and officials from affiliated institutions-Resolve simple, informal complaints of research study staff-Track IRB Authorization Agreements with institutions requesting reliance on UTHSCSA IRBs Show less

  • Associate Director, Institutional Review Board

    Apr 2012 - Feb 2016

  • IRB Expedited Reviewer, Institutional Review Board

    Sept 2007 - Apr 2012

  • Regulatory Affairs Coordinator

    Nov 2003 - Aug 2007
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  Ut southwestern medical center

  Feb 2016 - now

  Responsible for the Human Research Protection Program (HRPP), which includes the following offices: Institutional Review Board (IRB), Participant Advocacy, Regulatory Affairs Support, and Regulatory Monitoring at the University of Texas Southwestern Medical Center (UTSW). Key responsibilities include planning, developing, and implementing processes, systems, educational programs and other activities in collaboration with institutional and affiliate research offices. Provide guidance and support to researchers to ensure the safety and welfare of research participants is protected as required by applicable laws, regulations, University policies, and AAHRPP standards regarding human subject research. Show less Responsible for the direction and oversight of the Human Research Protection Program Office which includes administration of four IRB panels, and 24 FTE. Responsibilities include, and are not limited to, administration of the pre-review, initial and continuing human subject research protocol review; reliance relationships for external IRB's; required training; monitoring active protocols and programmatic processes for quality improvement; and compliance programs associated with an HRPP. Specific Responsibilities:o Provide scientific and expert regulatory consultation to faculty, research teams, staff and IRB members, including assistance with protocol development and feasibility assessments, in coordination with the Institutional Official and IRB chairpersons.o Facilitate integration of clinical research environment by aligning the HRPP, including IRB reviews, with research centers and cores throughout the institution to promote and support clinical research activities in a compliant and ethical environment.o Serve as a primary liaison with federal regulatory agencies and provide periodic updates and recommended actions to senior management as issues arise that demand institutional responses.o Serve as liaison with key internal and affiliate research departments to ensure coordination, efficiency and effectiveness of the HRPP and to resolve any conflicts.o Lead continuous process and operational improvement initiatives to reduce cycle-times, improve overall compliance posture, and remove unnecessary administrative burdens.o Implement and oversee an ongoing educational and training program for faculty and staff as it relates to conducting research involving human participants. Show less

  • Associate Vice President, Research Regulatory Affairs

    Oct 2024 - now

  • Assistant Vice President Human Research Administration

    Feb 2021 - Oct 2024

  • Director, Human Research Protection Program (HRPP)

    Feb 2016 - Feb 2021