Part-Time Compliance Specialist

Penn State University

Campus/Location:
College of Medicine at the Milton S. Hershey Medical Center
Date Announced:
07/08/2019
Date Closing:
07/14/2019
Job Number:
88977
Work Unit:
Penn State College of Medicine
Department:
Human Subjects Protection Office (HSPO)
Full/Part Time:
Part–Time

Description

Responsible for human research compliance review activities, including the review and approval of new research applications, continuation reports, modifications and Reportable New Information submissions to ongoing research studies and pre-review and preparation of research submissions for convened Institutional Review Board (IRB) committee review. In addition, this position involves managing studies reviewed by external IRBs, processing EIM requests, and implementing educational sessions for IRB members and researchers. New Application Review: Pre-review of new, externally-sponsored human research applications that require review by the convened IRB. Communicate by written memo, email, and telephone conversation with staff and/or faculty regarding any issues and documentation that may be needed to complete the review. Provide assistance to the research team in revising/writing submitted protocols, recruitment materials, and consent documents. Communicate with the Director and/or other members of the Human Subjects Protection Office (HSPO) regarding any potential problems that may delay review of the research by the convened board. Organize and assemble the submitted application materials for review by the convened Institutional Review Board (IRB). Maintain a database to track the progress of the pre-review process. New Application Review: Review of new human, investigator-initiated research applications that require review by the convened IRB. Confirm that the research has been assigned to the correct review category and evaluate the proposed research and assess the potential risks to potential participants. Communicate by written memo, email, and telephone conversation with staff and/or faculty regarding any issues and documentation that may be needed to complete the review. Provide assistance to the research team in revising/writing submitted protocols, recruitment materials, and consent documents. Communicate with Director and/or other members of the HSPO regarding any potential problems that may delay review of the research by the convened board. Organize and assemble the submitted application materials for review by the convened IRB and respond to email/telephone queries from Institutional Review Board members regarding the application packet prior to and/or during the convened IRB meeting. Maintain a database to track the progress of the pre-review process. Expedited/Exempt Research: Act as the primary or secondary reviewer of the submitted research protocol. Confirm that the research has been assigned to the correct category and evaluate the proposed research and assess the potential risks to potential participants. Communicate by written memo, email, and telephone conversation with staff and/or faculty regarding any issues and documentation that may be needed to complete the review. Provide assistance to the research team in revising/writing submitted protocols, recruitment materials, and consent documents. Approve the research once any outstanding issues are resolved. Maintain a database to track the progress of the expedited/exempt review and approval process Modification Requests: Analyze and evaluate proposed modifications, as assigned, for approved ongoing research investigations, including revisions to the protocol, consent forms, investigators, recruitment, enrollment and other proposed changes. Communicate by written memo, email, and telephone conversation with staff and/or faculty regarding any issues and documentation that may be needed to complete the review. Maintain a database to track the progress of protocol review from submission, document exchanges and final approval. Approve the modification request once any outstanding issues are resolved or determine that the changes requires review by the convened IRB. Organize and assemble the submitted application materials for review by the convened IRB if applicable. Maintain a database to track the progress of the pre-review.

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