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Research Compliance Manager

2 months ago

Philadelphia, United States Saint Joseph's University Full time

Position Title:

Research Compliance Manager
Time Type:

Full time
Position Summary and Qualifications:

The Research Compliance Manager works within the Office of Research Services and is responsible for managing the University’s research compliance program. This includes the administrative operations of the Institutional Review Board for the Protection of Human Subjects in Research (IRB), the Institutional Animal Care and Use Committee (IACUC), and the Institutional Biosafety Committee. This position is also responsible for administrating the Research Conflict of Interest and Export Control Programs, ensuring compliance with Federal regulations and institutional policies and procedures. This position coordinates the daily operations associated with the processing of human subjects, animal research, biosafety protocols, and all facets of protocol review and management, as well as the intake and review of Conflict of Interest and Export Control disclosures.

Essential Duties & Responsibilities:
Facilitate the accurate and timely processing and tracking of submissions to and actions by the IRB/IACUC/IBC committees.
Effectively communicating with Investigators, Sponsors, and Committee Members.
Work in conjunction with IRB, IACUC, and IBC chairpersons to ensure compliance with institutional policies and federal regulations governing the involvement of human subjects in research at the university.
Record IRB/IACUC/IBC meeting minutes in sufficient detail to document committee deliberations.
Set IRB/IACUC/IBC agendas and facilitate preparation of meeting materials for advance distribution to Board members.
Obtaining and distributing information required for IRB/IACUC/IBC review, maintaining files, preparing and distributing minutes.
Documenting communications with Sponsors, Investigators, regulatory entities, and others involved in the conduct of submitted research.
Maintaining a filing and archiving system that allows access to open and closed studies.
Issuing notifications of IRB/IACUC/IBC actions to investigators and appropriate entities.
Manage in-take and completion of conflict of interest and export control related disclosure and management plans.
Facilitate information sharing with the Office of General Counsel and other university offices as required.
Ability to analyze and apply Federal and State regulations regarding research compliance policies and procedures.
Working knowledge of and ability to interpret and apply ethical principles related to using human subjects and animals in research.
Review, update, and develop compliance policies and procedures.
Review and update submission forms.
Attend IRB/IACUC/IBC meetings and produce accurate committee meeting minutes.
Implement education and outreach programs for faculty, staff, and students.
Train and assist faculty and students on the use of IRBNet.
Monitor procedural updates announcements by federal agencies governing research.
Manage record-keeping practices, including organization reminders and communications.
Support performance of risk management and audit responsibilities.
Submit reports to federal agencies as required by regulations.
Maintain university assurances with federal agencies.
Able to manage multiple tasks
Secondary Duties & Responsibilities:
Work closely with ORS staff members to ensure compliance review with proposal submissions.
Update the compliance web page for external and internal users.
Presentations to a large audience.
Other duties as assigned.
Minimum Qualifications:
Required

Bachelor’s degree in the social or natural sciences, public administration, or related field.
At least three years experience working within a research compliance or research administration office, preferably in a university setting.
A basic understanding of federal and state laws and regulations governing human subjects, laboratory animal research, conflict of interest, and export controls is required.
Ability to communicate effectively in a training environment.
Experience with IRBNet or similar system.
Preferred

Certified IRB Professional (CIP) and/or Certified Professional IACUC Administrator (CPIA) preferred.
Physical Requirements and/or Unusual Work Hours:
Sitting for long periods
Working in front of a computer
Occasional light deliveries on campus
Occasional travel for educational seminars