The Research Compliance Manager supports the SJU research community in the design and conduct of innovative and ethical research by providing education, guidance and oversight with particular attention to adherence to commonly accepted federal, state and University policies, regulations and guidelines. Reporting to the Director of the Office of Research Services, the Research Compliance Manager serves as a principal resource for the SJU community and is instrumental in the administration of the Institutional Review Board for the Protection of Human Subjects in Research (IRB) so as to meet its primary responsibility of protecting the rights and welfare of human research subjects. This position is also responsible for the administration of the Institutional Animal Care and Use Committee (IACUC) in its review of protocols involving live vertebrate animals; ensuring compliance with applicable federal regulations, inspecting animal facilities, and overseeing training and educational programs. The Assistant Director works collaboratively with oversight committees, the Office of General Counsel and appropriate leadership, as needed, to design, develop, implement and monitor an effective program for education and compliance.
Duties and Responsibilities:
- Serves as expert on research involving human subjects from an operational, regulatory and strategic point of view.
- Gathers data, drafts and brings policies and/or revisions to leadership group (Director of ORS, IRB Chair, IACUC Chair) for further review and approval.
- Manage and maintain appropriate institutional assurances (current: FWA and USDA).
- Design, manage, implement and maintain training and education programs and track required certifications of research personnel (current: CITI)
- Analyze, interpret and apply federal, state and local regulations, policies and procedures related to research protections.
- Provide oversight for the ongoing work of the Institutional Review Board for Human Subjects in Research (IRB) including administrative operations, ensuring orientation and continuing education of IRB members, as well as development and implementation of policies and procedures of the board.
Provide oversight for the ongoing work of the Institutional Animal Care and Use Committee (IACUC) including administrative operations, ensuring orientation and continuing education of IACUC members, as well as development and implementation of policies and procedures of the committee.
- Advise investigators, students and administrators regarding federal regulations and institutional policies and procedures to ensure institutional compliance with ethical and regulatory requirements for research.
- Serve as resource to investigators offering support through the IRB and IACUC submission processes and providing counsel on research protections, ethics and integrity.
- Analyze and review all submissions to the IRBs web-based submission system to ensure completeness and compliance with applicable federal regulations, state laws and University policies. Corresponds with researchers, articulating necessary modifications/additions to study documentation to ensure completeness prior to IRB review.
- Determine whether protocols meet regulatory criteria for exemption and reviews and approves such protocols as “designated reviewer”. Correspond with researchers, articulating necessary modifications/additions to study documentation, including consent forms, in order to secure exemption.
- Review and assign Expedited/Full Board reviews to IRB members.
- Ensure that goals related to timely turnaround, accuracy and support of researchers are met.
- Maintain active knowledge of evolving laws, regulations, policies and ethical norms that are applicable to research activities through ongoing professional development.
- Facilitate the accurate and timely processing of submissions to and actions by the IRB/IACUC committees.
- Maintain effective communication with Investigators, Sponsors, and IRB and IACUC members.
- Work in collaboration with IRB chairperson to ensure compliance with institutional policies and federal regulations governing the involvement of human subjects in research.
- Work in collaboration with the IACUC chairperson to ensure compliance with federal regulations, both HHS and USDA, involving animal research.
- Work closely with the Animal Facilities Manager in facilitating the function of the IACUC committees.
- Set IRB/IACUC agendas and facilitate preparation of meeting materials for advance distribution to Board/Committee members.
- Record, prepare and distribute IRB/IACUC meeting minutes in sufficient detail to document committee deliberations.
- Obtain and distribute information required for IRB/IACUC review.
- Document communications with Sponsors, Investigators, regulatory entities, and others involved in the conduct of submitted research.
- Maintain an accurate and comprehensive record of reviewed and approved research.
- Implement and manage post-approval monitoring programs for human subjects and animal research programs.
Train and assist faculty and students on the use of IRBNet and CITI Program.
- Monitor procedural updates announcements by federal agencies governing research.
- Act as a voting member (regulatory expert) on the IRB committee.
- Facilitate bi-annual IACUC Program and Facility Review.
- Prepare and maintain reports and records for annual, unscheduled, USDA Inspection.
- Submit reports to federal agencies as required by regulations.
Analyze, interpret and apply international regulations, policies and procedures related to research protections.
Physical Requirements and/or Unusual Work Hours:
- Liaise and collaborate with university personnel as needed in regard to human and animal research compliance matters (i.e. General Counsel, Institutional Safety Officer, Biosafety Committee, Animal Facilities Manager, Facilities)
- Manage ORS web design and maintenance.
- Sitting for long periods of time
- Working on computer
- Occasional light deliveries on campus
- Occasional travel for educational seminars
- Bachelor’s degree.
- At least 5-years’ experience working in a university or research instiution setting, preferably in research compliance.
- Understanding of research compliance specifically related to IRB and IACUC
- Ability to communicate effectively in a training environment.
- CIP (Certified IRB Professional), or ability to obtain certification within 18 months after hire date.
- Basic knowledge of MS Office required.
- Ability to work independently, prioritize and work under constant deadlines
- Master’s Degree
- Prior experience with USDA regulations and inspections.
- Experience in developing policies and procedures
Experience with web-based research management system (IRBNet)
- Experience with Google G Suite
Position Classification: Professional Union: None Number of direct reports to this position: 0 Department: 281051 - Office of Research Services Band: 15 Date Open to Internal Applicants: 09/07/2018 Date Open to External Applicants: 09/12/2018 Job Close Date: Open Until Filled Yes