13 days old

Director, Human Research Protection

MemorialCare
Fountain Valley, CA 92708
  • Job Code
    MEM004944

Position Summary:



The MemorialCare Human Research Protections department (MHRP) is responsible for: 1) Protecting the rights, welfare, and well-being of human subjects involved in research; 2) Enabling and supporting the MemorialCare Research Program through an effective IRB process; and 3) Establishing, managing, and ensuring effective HRP, IRB, and related workflows and operational transparency.



The Director of MHRP oversees the essential components of the program: IRB administration, research compliance, research integrity, financial conflicts of interest, and training and education. This individual will assist the Executive Director of MemorialCare Research in responding to inquiries from the Office of Human Research Protections and the Food and Drug Administration. The Director also facilitates support for IRB and Privacy Board review and approval, Data Safety Monitoring, Scientific Review, and additional functions of human subjects protections and research integrity (as such committees and boards may be established).



Principal Duties and Responsibilities:



  • Develop and maintain MHRP infrastructure: Policies, procedures, and guidance manuals, and MemorialCare Federalwide Assurance (FWA).

  • Support MHRP functions, committees, boards and researchers through interpretation of federal and state laws and regulations, and institutional policy and procedure.

  • Direct the performance of routine and directed audits and monitoring, investigations of scientific misconduct, and compliance concerns submitted via the Compliance Hotline.

  • Establish and manage IRB reliance and Central IRB agreements, as well as the front-end and back-end processes that support these agreements.

  • Oversee HRP functional responsibilities such as serving as the reporting representative to the Compliance Committee and Audit Committee, defining the reporting of serious or continuing noncompliance in human subjects research, and developing Lean workshop initiatives and Gallup performance evaluations.

  • Hire and manage MHRP staff, including managers, supervisors, and analyst team members, as well as managing the educational opportunities, expectations and motivations within their respective roles.

  • Collaborate directly with senior leadership such as the MHS IRB Chair(s) and Vice Chair(s), as well as the leadership of associated research functions: Operations, Finance, and Sponsored Projects.

  • Develop and Defend the distribution and accounting of department budget.


Experience



  • At least five years management experience overseeing the day to day operations of the following: IRB project submission process, central IRB agreements, reliance IRB agreements, scientific review, allegations of scientific misconduct, research-specific auditing and monitoring, electronic solution integration and maintenance, budgeting and strategic planning, and research-specific training and education, preferably in a healthcare or academic medical center environment.

  • Additionally, this individual must have demonstrated the ability to recruit, hire, develop, and maintain staff representing the various disciplines of HRP, as well as proving to possess excellent oral and written communication skills.

Education



  • This individual would ideally possess certification from at least two of the following research organizations: PRIM&R (CIP certification), SOCRA (CCRP certification), or ACRP (CCRA, or CCRC certification).

  • Bachelors degree(s) in Business, Communications, Clinical Research, Psychology, Biology, or Health Care required. Advanced degree(s) preferred.






Posted: 2021-06-07 Expires: 2021-07-06
Sponsored by:
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Director, Human Research Protection

MemorialCare
Fountain Valley, CA 92708

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