Research Project Manager 3

Penn State University

Campus/Location:
College of Medicine at the Milton S. Hershey Medical Center
Campus City:
Hershey, PA
Date Announced:
07/09/2019
Date Closing:
07/15/2019
Job Number:
89035
Level/Salary Band:
03 – K – Exempt
Work Unit:
Penn State College of Medicine
Department:
OVDRGS
Full/Part Time:
Full–Time

Description

Reporting to the Vice Dean for Research and Graduate Studies through the Associate Dean for Clinical Research at the Penn State College of Medicine, this position acts as the daily operations and implementation lead on Penn State research policies and procedures at Penn State St. Joseph. In this capacity, this position is responsible for communicating procedural changes to ensure compliance with Penn State requirements, rolling out these changes, and conducting supervisory oversight to ensure policies are being followed across the Penn State St. Joseph enterprise. This position works closely with the COM HSPO team, the PSH Research Integration Team, the COM Clinical Trials Office, the COM Office of Research Affairs, and additional Penn State Health offices as the clinical enterprise needs dictate. As the lead on implementing Penn State policies and procedures around research on site at Penn State Health St. Joseph, this position also liaises and collaborates directly with various University Park enterprise offices, including the Office of Research Protections (ORP) and the Office of Research Information Systems (ORIS). Additional aspects to the position include a role acting as the primary manager of both the Institutional Review Board operations and the Clinical Research Operations Group (CROG) at Penn State St. Joseph. This role is responsible for the management of the Penn State Health St. Joseph Clinical Research Department and the administration of the Human Subjects Research Protection Program through management of the Penn State St. Joseph Institutional Review Board (IRB). On site at Penn State St. Joseph, the incumbent works with the Penn State St. Joseph IRB Chair and relevant COM and PSH parties to provide approval and oversight for all clinical trials, including investigational drug, device, procedure and data collection protocols, conducted at or associated with Penn State Health St. Joseph. This position is responsible for maintaining compliance with Food and Drug Administration (FDA), Federal Wide Assurance (FWA) and Office of Human Research Protections (OHRP) Policy and Procedure in accordance with Federal and State Law regarding human subject research. In addition, the incumbent works with the CROG Chair in providing leadership and oversight of the process for operationalizing all clinical trials conducted at Penn State St. Joseph. CROG responsibilities include, but are not limited to, knowledge and application of CMS clinical trial billing regulations, liaison for the Clinical Research Department among research staff, hospital departments, legal department, administration and external partners. In this role the incumbent also serves as a resource for Clinical Research inquiries and education. Liaises with Associate Dean for Clinical Research at PS COM, HSPO, PS COM Clinical Trials Office, Penn State Health, University Park Office for Research Protections and Research Information for development, roll-out, and adherence to Penn State research policies and procedures at Penn State St. Joseph. Develops, with Penn State Health Research Integration project manager, relevant training materials and process mapping materials for workflow. Provides operational and logistic support for transitioning existing paper-based procedures to computer-based documentation and processing. Acts as primary point of contact to report into PS COM Conflict of Interest for disclosures and submission for review. Acts as primary point of contact for initiation of new research projects across Penn State St. Joseph’s, directing questions to appropriate parties and necessary, filing requisite information to begin processes, and tracking and reporting outcomes to PS COM leadership. Coordinates IRB process for new protocol submissions, amendments, renewals, revisions, adverse events, protocol deviations, study closure and final reports. Reviews all applications to the IRB, including Informed Consent to determine completeness and consistency with federal guidelines and institutional requirements. Reviews complex scientific research protocol documents and identifies regulatory issues and communicates those issues to IRB Chairs, members and study staff with the goal of resolution. Collaborates with the Missions and Ministry Department to ensure all clinical trials conducted at Penn State Health-St. Joseph are aligned with the Catholic Directives in place at the hospital. Meets regularly with IRB Chair to perform expedited reviews and facilitate IRB administration. Coordinates IRB meetings and prepares electronic meeting documentation via Diligent Boards. Prepares IRB meeting minutes per FDA Guidance for Institutions and IRBs. Communicates results of IRB reviews to Principle Investigators via documentation written in an organized, clear, concise manner. Prepares invoices for IRB Administrative Services for payment from clinical trial Sponsors. Processes payments to IRB from Clinical Trial Sponsors. Facilitates completion of Regulatory documents with the NCI Central IRB for Oncology Cooperative Group trials. Maintains Regulatory files per FDA Guidelines. Maintains/updates/develop policy and procedures for the IRB consistent with SJMC directives and Government regulations. Assists IRB Chair with the selection, orientation and training of new IRB members, including maintenance of education/training files. Provides guidance and training to investigators and research staff regarding IRB procedural requirements and clinical research. Reports potential or actual compliance issues to Corporate Compliance Officer. Coordinates process for CROG review and approval of new clinical trials, amendments and study closures. Meets regularly with CROG Chair to perform clinical research expedited reviews and facilitate CROG administration. Reviews clinical trial study budgets and contracts for consistency with SJMC policy, Federal regulation and Good Clinical Practice guidelines. Communicates discrepancies or issues to research staff and CROG members with the goal of issues resolution. Works in conjunction with the revenue integrity department to ensure proper medical coding and CMS regulations have been applied to all research patient accounts. Maintains/updates/develop policy and procedures for the Clinical Research Department consistent with SJMC directives and Government regulations. Typically requires a Master's degree or higher plus four years of related experience, or an equivalent combination of education and experience.

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