Compliance Manager 4 (Director, Human Subjects Protection Office)

Penn State University

Campus/Location:
College of Medicine at the Milton S. Hershey Medical Center
Campus City:
Hershey, PA
Date Announced:
09/06/2019
Date Closing:
open until filled
Job Number:
90647
Level/Salary Band:
04 – M – Exempt
Work Unit:
Penn State College of Medicine
Department:
Human Subjects Protection Office
Full/Part Time:
Full–Time

Description

The Pennsylvania State University seeks a highly motivated and experienced IRB leader with a focus on customer service and collaboration to serve as the Director of the Human Subjects Protection Office (HSPO) at the Penn State College of Medicine (located in Hershey, PA). Reporting to the Executive Director of Research Compliance in the Office for Research Protections (ORP), the Director will serve as the overall program manager for the IRB program for the Penn State College of Medicine. The Penn State College of Medicine has five IRBs that review and provide oversight for biomedical and social science research studies conducted by investigators from the College of Medicine and Penn State Health, which includes the Penn State Health Milton S. Hershey Medical Center and the Penn State Health St. Joseph Regional Health Network and other affiliates. As part of the Office of the Vice President for Research, the HSPO supports Penn State’s active research enterprise: Penn State’s research expenditures reached a new high of $927 million in 2017-18, ranking it in the top 25 of the nation’s public research universities. Penn State’s IRB program has been AAHRPP accredited since 2006. The Director of the HSPO will serve as the overall program manager for the IRB program, including administration of the office's budget and supervision of staff. The Director ensures the office maintains a service-minded approach while maintaining the highest standards of compliance for over 2000 active protocols. As the resident IRB expert, the Director will develop and administer compliance programs and policies related to the human research protection program (HRPP); interpret and maintain compliance with federal, state and institutional regulations, guidance and policies; be responsible for compliance related to reportable new information (e.g., non-compliance); evaluate effectiveness of the HRPP and use of resources; and ensure appropriate training of University researchers and collaborators. The Director of the HSPO sets the tone and standard of collaboration for the IRB program, working with investigators, faculty, and staff to advance their research goals while also ensuring a high level of compliance. The Director is expected to demonstrate a commitment to diversity, inclusion, and transparency. The Director will be responsible for collaborating and working proactively with key constituents and leadership across the Penn State College of Medicine, Penn State Health, the Office for Research Protections, and other compliance and administrative offices as appropriate for the purposes of ensuring compliance with regulations and policy. The Director will work closely with the Executive IRB Chair, the Executive IRB Committee, and the HSPO Assistant Director. Importantly, the Director of the HSPO will also work with the IRB Program Director in the Office for Research Protections on the shared IRB policies, procedures, and electronic system; both IRB Directors at HSPO and the ORP report to the Executive Director of Research Compliance. The Director will collaborate with colleagues nationally regarding best practices and to maintain benchmarking standards for the HRPP, particularly with partner institutions in the Big Ten Academic Alliance and the NCATS Trial Innovation Network. Penn State’s IRB program is a member of the Flex Coalition and participates in the SMART IRB National IRB Reliance Initiative, and Penn State is viewed as a leader in the Huron community for end users of the Huron IRB system and HRPP toolkit. The Director is expected to attend and present at regional and national conferences, to pursue ongoing professional education, and to stay current on federal regulation, guidance and accreditation standards. The Director will be responsible for all external reporting to federal and accrediting agencies. The Director, along with the IRB Program Director at the ORP, is responsible for maintaining AAHRPP accreditation. Typically requires a Master's degree or higher plus five years of related experience, or an equivalent combination of education and experience. Demonstrated experience with leadership responsibility in a human subject protection program; relevant research experience ideal. This position requires exceptional professionalism and proven effectiveness as a networker, communicator, problem-solver, and negotiator, with a strong customer-service orientation. It is critical that the candidate demonstrate exceptional verbal and written communication skills and the ability to communicate with transparency. Proficiency with Microsoft Office and knowledge of electronic data management systems expected. Must be able to exercise sound, independent judgment and discretion; must maintain confidentiality. National certification as an IRB Professional (CIP) expected. The ideal candidate will have knowledge of and experience with AAHRPP standards and accreditation requirements; knowledge of HIPAA regulations and state laws governing privacy and security of protected health information; and in-depth understanding of laws, rules, and regulations governing human subject research.

How To Apply On This Position

The Pennsylvania State University has retained the services of Isaacson, Miller, a national executive search firm, to assist the Search Committee in its identification and review of candidates. Confidential inquiries, nominations, referrals, and curriculum vitae with cover letters should be directed in confidence to:


Rebecca Kennedy, Partner
Caitlin Barrett, Senior Associate
Isaacson, Miller
263 Summer Street
Boston, MA 02210
https://www.imsearch.com/7261
Electronic submission is strongly encouraged

These salary bands have been established to provide salary guidelines for staff positions.

Salary Band Minimum Midpoint Maximum
A $16,584 $24,456 $32,328
B $18,240 $26,904 $35,556
C $19,728 $29,592 $39,456
D $21,708 $32,568 $43,416
E $24,312 $36,468 $48,612
F $27,228 $40,848 $54,456
G $30,012 $45,744 $61,500
H $34,188 $52,140 $70,080
I $38,988 $59,424 $79,908
J $43,716 $67,740 $91,812
K $50,712 $78,600 $106,488
L $58,836 $91,176 $123,528
M $68,232 $105,756 $143,292
N $80,508 $124,788 $169,068
O $93,492 $147,252 $201,024
P $110,340 $173,760 $237,192
Q $126,396 $199,056 $271,728
R $151,668 $238,872 $326,088