As part of our continued commitment to providing a safe and healthy workplace, Phoenix Children’s is officially a mandatory COVID-19 vaccination organization, effective October 1, 2021. All new employees must be fully vaccinated prior to starting employment at Phoenix Children’s. Having a vaccinated workforce is an important step in supporting our mission to provide hope, healing and the best healthcare for the children in our community.

Position Details

Department: RSRCH-GRNT | Clinical Research Admin
Category: Director/Management
Location: Phoenix
Posting #: 730457
Date Posted: 2/20/2023
Employee Type: Regular

Position Summary

The Manager, Research Ethics/Human Subjects Protection Program (HRPP) has managerial and operational oversight of organizational regulatory, research ethics, the Institutional Review Boards (IRB), Research Compliance and Conflicts of Interest Committee (RCC), Research Credentialing, and the Scientific Review Panel (SRP). He/She functions as a regulatory and research policy resource/expert for research faculty and staff. In addition, this position also works closely with the Director of Research Operations, SVP Research and organizational leadership for the coordination and stimulation of research and knowledge development initiatives. This position will facilitate, foster, and grow collaborations to achieve the short and long-term research goals for Phoenix Children’s.

PCH Values

  • Family-Centered care that focuses on the need of the child first and values the family as an important member of the care team
  • Excellence in clinical care, service and communication
  • Collaborative within our institution and with others who share our mission and goals
  • Leadership that set the standard for pediatric health care today and innovations of the future
  • Accountability to our patients, community and each other for providing the best in the most cost-effective way.

Position Duties

  1. Oversees and coordinates HRPP activities including the Scientific Review Committee, oversight of offices and staff that have roles in protecting human research subjects, research credentialing, monitoring of approved research studies, education and training, policy development, and IRB operations. Liaise with the Office of Research, research compliance and internal audit representatives as appropriate.
  2. Oversees and ensures employee engagement, adequate staffing levels, HRPP budget development and compliance. Responsible for staffing decisions such as hiring of competent and qualified individuals, terminating employment, mentoring, and counseling employees on work-related performance.
  3. Stays current with changing regulatory guideline Develops and maintains written operational policies and procedures for the HRPP that are consistent with current regulatory guidelines and communicate pertinent information to staff in a timely and accessible manner. Coordinates appropriate activities with the Office of Compliance and Privacy.
  4. Serves as the human subjects protection officer/ethics officer for Phoenix Children’s. Primary institutional liaison for state and federal regulatory oversight bodies (e.g. NIH OHRP, FDA, AZDH) and maintains institutional assurances and regulatory reports.
  5. Assists the Director, Clinical Research Operations & SVP Research with the development of short and long term strategies to improve the research support needs of investigators at Phoenix Children’s.
  6. Develop metrics and regular reporting for workload volume and review timelines, as well as other reports as requested; align to industry best practices.
  7. Assists the Director, Clinical Research Operations & SVP Research with identifying research areas with high probability of external funding. Maintains high quality, responsive, collegial, and trustworthy relationships with internal and external stakeholders supporting research at Phoenix Children’s.
  8. Develops programs to stimulate synergistic interactions among institute scientists and affiliated external organizations.
  9. Responsible for maintaining AAHRPP certification requirements.
  10. Oversees sponsored project processes to assure compliance with all federal, state, and regulatory agency requirements; notifies SVP Research of potentially serious adverse effects, non-compliance, and/or logistically difficult projects.
  11. Responsible for reviewing and evaluating conflicts of interests and developing management plans where necessary with the VP of Compliance and Office of Business Integrity.
  12. Performs miscellaneous job related duties as requested.

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Position Qualifications

Please review the following qualifications and specify whether you meet each of the requirements listed.
Do you meet this requirement?
1. BS Required
2. Advanced Degree in a related field Preferred
Do you meet this requirement?
1. Three (3) or more years of experience with Human Research Protection Program Management. Required
2. Three (3) or more years of experience in academics, and/or healthcare industry. Required
3. Three (3) or more years of leadership experience. Required
Do you meet this requirement?
1. CIP Preferred
Do you meet this requirement?
Special Skills
1. Demonstrated understanding, and detailed working knowledge of federal regulations and agency guidelines for conducting research and the protection of human subjects is necessary. Required
2. Demonstrated effective verbal and written communication skills, including ability to constructively resolve conflicts and problem solve among HRPP stakeholders. Required
3. Strong interpersonal skills and ability to diplomatically navigate complex and sensitive situations. Required
4. 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. Required
5. Ability to synthesize information from multiple sources to produce succinct, detail-oriented, and accurate documents, policies, reports, and announcements. Required
6. Advanced competence using an electronic IRB management system, and other technological products that facilitate effective management. Required
Physical Requirements & Occupational Exposure/Risk Potential
1. Physical Requirement - Climbing Occasionally
2. Physical Requirement - Feeling (sensing textures and temperatures) Occasionally
3. Physical Requirement - Fine Motor Skills (pinching, gripping, etc) Occasionally
4. Physical Requirement - Hearing Constantly
5. Physical Requirement - Pushing/pulling Occasionally
6. Physical Requirement - Reaching Occasionally
7. Physical Requirement - Sitting Frequently
8. Physical Requirement - Standing Frequently
9. Physical Requirement - Stooping/crouching/kneeling/crawling Occasionally
10. Physical Requirement - Talking Constantly
11. Physical Requirement - Tasting/smelling Occasionally
12. Physical Requirement - Walking Constantly
13. Physical Requirement - Near Vision Constantly
14. Physical Requirement - Far Vision Constantly
15. Physical Requirement - Color Discrimination Frequently
16. Physical Requirement - Use of keyboard, mouse and/or computer equipment Constantly
17. Physical Requirement - Lift up to 35 pounds without assistance Occasionally
18. Physical Requirement - Lift more than 35 pounds without assistance Occasionally
19. Occupational Exposure/Risk Potential - Inside office environment Applicable
20. Occupational Exposure/Risk Potential - Outdoor weather conditions Applicable
21. Occupational Exposure/Risk Potential - Extreme temperatures Applicable
22. Occupational Exposure/Risk Potential - Confined areas Applicable
23. Occupational Exposure/Risk Potential - High places Applicable
24. Occupational Exposure/Risk Potential - Extreme noise levels Applicable
25. Occupational Exposure/Risk Potential - Airborne communicable diseases Applicable
26. Occupational Exposure/Risk Potential - Bloodborne pathogens or bodily fluid Applicable
27. Occupational Exposure/Risk Potential - Fumes or airborne particles Applicable
28. Occupational Exposure/Risk Potential - Hazardous materials exposure Applicable
29. Occupational Exposure/Risk Potential - Radiation exposure Applicable
30. Occupational Exposure/Risk Potential - Toxic or caustic chemicals Applicable
I have reviewed the qualifications, physical requirements and occupational exposure/risk potential for this position and wish to apply