| Director, Human Research Protection Program -- Danville, PA |
Author: Jon Merz
Date: 06-24-11 16:34
Title: Director, Human Research Protection Program
Job Summary:
Having an effective, supportive, flexible and yet compliant human research protection program is fundamental to Geisinger's success at building its research enterprise and in achieving the goals of the research strategic plan. A complicated human research protection program with over 600 active protocols, internal and external IRBs, the availability of EHR and GHP data sources, the extensive QI and innovation projects, innovative tissue and data broker arrangements, and changing ratios of exempt and non exempt research, the mix of research presents challenges not found at most institutions.
This leadership position is responsible for guiding and ensuring the Geisinger Health System's compliance with international, federal, state, and local rules and regulations and ethical principles regarding the use of human subjects in research, the use of PHI in research activities (HIPAA), and ensuring that research at Geisinger involving human subjects is conducted in a manner which protects the safety, rights, and welfare of all subjects. To accomplish these mutually reinforcing goals, the Director works with the Institutional Official (the Chief Scientific Officer), Chief Administrative Officer for Research, the Chairs of the Institutional Review Board (IRB), the Director of Research Compliance, Legal Services, Internal Audit, Privacy and others to coordinate and manage a comprehensive program for the protection of human subjects in research (HRPP). To do this, the Director is responsible for establishing, maintaining, and continually improving the policies, systems and procedures for review, approval and continuing oversight of the use of human subjects or their PHI by researchers affiliated with Geisinger through the Geisinger IRBs (GIRB), facilitated review processes, or through contracted IRBs. The ability to effectively train and develop the capabilities of IRB chairs and members, as well as training the general Geisinger community is a key factor in the success of the position, as is the ability to translate and communicate to the research community the subtle nuances of the regulations and the way they are applied to different types of research.
Reports to the Chief Administrative Officer for Research.
SKILLS AND ABILITIES:
Demonstrated proficiency with the regulatory guidelines for human subject participation in research and ability to apply these complex regulations and policies to diverse types of research.
Demonstrates excellent verbal and written communication skills and ability to interact with researchers and other employees in a positive and confident manner.
Demonstrates excellent organizational skills necessary to establish priorities and meet deadlines while attending to details.
Demonstrates well developed supervisory and leadership skills.
Demonstrates ability to maintain professional standards of conduct under severe time constraints.
Demonstrates ability to work independently and cooperatively and to function successfully under time pressures.
Demonstrates ability to maintain confidentiality of information and records.
Demonstrates excellent interpersonal skills to effectively interact with diverse clients.
EDUCATION AND/OR EXPERIENCE:
Bachelor of Arts or Science degree required. Master's or advanced degree preferred.
Minimum ten years senior administrative experience in regulatory compliance and research with human subjects required.
Expert knowledge of regulatory and agency requirements for the ethical conduct of research with human subjects and quality assurance programs routinely required by the Department of Health and Human Services (OHRP, Food and Drug Administration, including Good Clinical Practice. National Institutes of Health, Office of Civil Rights) required. Familiarity with other relevant regulations for the use of biological agents, radiation, animals, conflicts of interest, misconduct, and other relevant principles.
Experience conducting clinical research or working in institutions with a range of research types, including clinical trials, clinical research, epidemiology and other types of social sciences research.
Significant supervisory experience required.
CIP certification preferred (may be substituted for some of the
requirements above).
WORKING CONDITIONS/PHYSICAL DEMANDS:
Work is typically performed in an office environment.
Please apply:
Phyllis A. Scott
Corporate Recruiter
Talent Acquisition
Geisinger Medical Center
100 North Academy Avenue
M-28-11
Danville, PA 17822
pascott@geisinger.edu
570-214-2265
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| Topics |
Author |
Date |
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Director, Human Research Protection Program -- Danville, PA |
|
Jon Merz |
06-24-11 16:34 |
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