Job Summary

This position, reporting to the Senior Vice President, Medical Affairs, is responsible for overseeing and ensuring the efficient and effective operations of the Human Subjects Protection Program (HRPP) which includes the Harris Health System Research Approval Process, Quality Improvement Project Approval Process, Institutional Review Board, and Research Staff Authorization, and verifying that the enterprise meets compliance with DHHS and FDA regulations and applicable guidance related to research involving human subjects. Serves as knowledgeable point of contact for OHRP, FDA, recognized IRBs, and affiliate academic partners research staff. Serves as an advisor and resource in the field of human subjects' protection, regulatory compliance and quality improvement associated with research protocols and quality improvement projects conducted at Harris Health.

Minimum Qualifications

Master's Degree from an accredited college/university (And) minimum of five (5) Years Research Work Related Experience with at least two (2) Years in a Leadership role. Previous experience with human subjects protections programs is required. Earned PhD and health care clinical background in academic setting preferred.

-Must have thorough knowledge of federal regulations, state laws and accreditation
-A demonstrated track record of effective leadership.
-Preferred advanced degree (e.g., PhD)

Licenses & Certifications:
Certified IRB Professional (CIP) or Certified IRB Manager (CIM) must be completed within 2 years from the date of hire.

Communication Skills:
Exceptional Verbal (e.g., Public Speaking)
Bilingual Skills Required: No
Writing / Correspondence
Writing / Reports

Proficiencies: MS Word, P.C.

Knowledge/Skills/Abilities:
Analytical, Medical Terms, Research, Statistical

Work Schedule: On site; flexible

Other Requirements: Knowledge of federal regulations and policies governing human subjects; training in health care field; certification as an IRB professional or manager, or eligibility for certification preferred

Typical duties that may be performed:

Oversight of Research Office

Serves as the Human Protection Administrator for the system wide Human Research Protection Program (HRPP) responsible for administrative and staff oversight for the activities of the Research Department which oversee approximately 870 active biomedical/clinical research protocols, ensuring compliance with Federal, State, and Harris Health mandates governing human subjects in biomedical research.
a.) Maintains Harris Health's Federal wide Assurance (FWA) and ensure compliance with its terms, as well as Harris Health policies and procedures, federal regulations, and state and local laws relative to the conduct of human research studies.
b.) Provides guidance regarding the interpretation of regulations, laws, and policies to the organization IRB, researchers, staff, and administrators.
c.) Maintains current knowledge of human research protection guidance and regulations as they evolve. Stays current on emerging issues. Monitors federal regulatory websites and other research related resources as to stay current with regulatory changes in human research protections guidelines and policies. Communicates pertinent information to staff and others with a need to know in a timely manner.
d.) Coordinates the development and final approval of Letters of Support for research.
e.) Oversees research electronic management system including decision making capacity regarding additional tech support, upgrades and other related matters.
f.) Serves as a full voting member in Harris Health recognized affiliate university or organization IRB meetings.
g.) Directs, coordinates, and supervises the administrative and clerical functions of the research Administrative Approval Process and the Quality Improvement Project Approval Process.

Oversight of Institutional Review Board (IRB)
Responsible for administrative and staff oversight of the Harris Health IRB in support of research protocols to include planning, interpreting, and coordinating procedurals activities within the scope of relevant federal regulations involving human subjects research.

1. Services as chief administrative and programmatic support for the IRB.
2. Provides consultation, assistance, and dissemination regarding the review process.
3. May serve as the Chairperson of the Harris Health IRB.
4. Maintains OHRP IRB Registration updates.
5. Directs, coordinators and supervises the administrative and clerical functions of the IRB Office.

Oversight of Authorization and Onboarding of Research Personnel
Responsible for administrative and staff oversight of the formal, systematic annual authorization approval process and onboarding for over 300 non-Harris Health employed Research Personnel, in accordance with Harris Health policies and DNV standards, for conducting research tasks in the Harris Health.

a.) Coordinates the development, implementation and maintenance for over 500 non-Harris Health employed Resea