Person, Nurse, Doctor

Director Human Research Protection Program, Full Time.

Kansas City, Missouri.

JobReq0033484

 

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Director Human Research Protection Program

  • 4401 Wornall Rd, Saint Luke's Hospital of Kansas City - Plaza, Kansas City, Missouri, United States, 64111
  • Research Job Family
  • Full Time

Job Description​

The Director, Human Research Protection Program (HRPP), is responsible for providing direction, execution, and oversight to all core components of the organization’s human research protection program, including the IRB and IRB Boards.  The position works closely with various offices and staff that have roles in protecting human subjects research at Saint Luke’s Health System (SLHS).

  • Maintain SLHS’s Federal Wide Assurance and ensure compliance with its terms, as well as SLHS policies and procedures, federal regulations, and state and local laws relative to human research subject protection.

  • Provide guidance regarding the interpretation of regulations, laws, and policies relative to human research subject protection to the organization’s IRBs, researchers, staff, and administrators.

  • Develop and implement SLHS human research subject protection policies and procedures, updating as needed.

  • Oversee and coordinate HRPP activities across the various offices and staff that have roles in protecting human research subjects (including compliance, monitoring of approved research studies, education and training, policy development, and IRB operations); build relationships with internal stakeholders (including consulting with researchers) and liaise with the Office of Research Services Staff, research compliance and internal audit representatives as appropriate; work with various stakeholders to build consensus. 

  • Ensure employee engagement, adequate staffing levels, and budget development and compliance, and be responsible for staffing decisions such as hiring of competent and qualified individuals, terminating employment, coaching, and counseling employees on work-related performance, and developing and implementing policies and procedures to ensure a safe and effective work environment.

  • Ensure that effective and standardized human subjects research protection training is available and completed by all investigators, key study personnel, and all SLHS staff who participate in human subjects research.

  • Oversee the quality assurance monitoring of the HRPP, including investigation of matters of noncompliance; and ensure implementation of corrective action, as needed, in accordance with the policies and procedures of SLHS and the IRB. 

  • Provide oversight and support for the SLHS IRBs.

  • Represent SLHS HRPP as a liaison with regulatory agencies, accrediting bodies (as applicable), and funding agencies.

  • Maintain current knowledge of human research protection regulations and guidance as they evolve, including staying current on emerging issues; and communicate pertinent information to staff in a timely and accessible manner.

  • Develop metrics and regular reporting for workload volume and review timelines, as well as other reports as requested; align to industry best practices.

  • Other duties as assigned.

Requirements:

  • Advanced degree in a related field, a minimum of 5 years experience in a leadership position and a minimum of 5 years experience with human research compliance; CIP certification preferred.

  • Ability to exercise sound and consistent judgment within a defined process.

  • Demonstrated understanding, and detailed working knowledge of federal regulations and agency guidelines for conducting research and the protection of human subjects is necessary.

  • Demonstrated effective verbal and written communication skills, including ability to constructively resolve conflicts and problem solve among HRPP stakeholders.

  • Strong interpersonal skills and ability to diplomatically navigate complex and sensitive situations.

  • Proven leadership and management skills, including establishing and measuring goals and objectives, optimizing and monitoring work assignments, facilitating career development, and encouraging staff member growth and retention. 

  • Ability to synthesize information from multiple sources to produce succinct, detail-oriented, and accurate documents, policies, reports, and announcements.

  • Advanced competence utilizing MS Office suite, computerized databases, and other technological products that facilitate effective management.

Job Requirements

Applicable Experience:

3-5 years

Cert Institutional Review Board Prof - Institutional Review Board

Master's Degree

Job Details

Full Time

Day (United States of America)

The best place to get care. The best place to give care. Saint Luke’s 12,000 employees strive toward that vision every day. Our employees are proud to work for the only faith-based, nonprofit, locally owned health system in Kansas City. Joining Saint Luke’s means joining a team of exceptional professionals who strive for excellence in patient care. Do the best work of your career within a highly diverse and inclusive workspace where all voices matter.

Join the Kansas City region's premiere provider of health services. Equal Opportunity Employer.

Effective November 1st, 2021, full COVID-19 vaccination is a condition of employment for all Saint Luke’s Health System employees unless a medical or religious exemption is approved.

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