Associate Director for Research Compliance
Posted with Limited Access:
Associate Director for Research CompliancePosting Number:
Full-timeTypical Hours Per Week:
38.75Regular, Temporary or Term:
Sciences Technical Support ServicesLocation:
Middlebury, VT CampusHire contingent upon successful completion of the following post-offer screening:
Criminal Background CheckPosition Summary:
The Associate Director for Research Compliance: 1) oversees animal programs and programs in the sciences related to environmental, health, and safety; and 2) coordinates the administration, support, monitoring, and oversight for a range of non-ﬁscal research compliance functions, including protection of human subjects, animal care and use, export controls, and research involving radiation, biohazards, and other controlled substances.Essential Functions:
Offer is contingent upon successful completion of a criminal background check.
•Serves as the campus contact for information about best practices and government regulations related to research compliance and the responsible conduct of research.
•Oversees animal programs, working closely with IACUC chair and attending veterinarian to determine requirements and ensure full compliance with USDA, NIH-OLAW, AAALAC, and other regulations and standards applicable to animal care and welfare.
•Establishes policies and procedures related to animal care, vivarium operations, and environmental health and safety, in conjunction with IACUC, attending veterinarian, and Vivarium Manager.
•Coordinates activities related to achieving AAALAC reaccreditation.
•Hires and supervises Vivarium Manager, and contracts with the attending veterinarian.
•Oversees laboratory support functions related to laboratory safety, chemical hygiene, radiation safety, and hazardous waste management.
•Hires and supervises Laboratory Stores and Safety Manager, Senior Laboratory Technician, and Greenhouse Curator.
•Serves as Radiation Safety Officer.
•Provides guidance to faculty, students, and other administrators on requirements pertaining to the Institutional Review Board, Institutional Animal Care and Use Committee, and the Institutional Biosafety Committee, as well as institutional policies on Financial Conflict of Interest and Research Misconduct.
•Works in coordination with the Ofﬁce of Grants and Sponsored Programs and the Ofﬁce of Grant and Contract Administration.
•Committee-speciﬁc responsibilities include:
1.Institutional Review Board (IRB)
oMaintains all registrations with relevant federal agencies and keeps federal compliance summary current; monitors compliance between IRB protocols and grants.
oScreens all IRB applications and determines level of review; reviews and approves or exempts protocols as delegated by the IRB Chair; facilitates protocol modiﬁcations and Authorization Agreements.
oSets submission deadlines for applications, schedules committee meetings, assembles and distributes meeting packets, takes meeting minutes.
oSends formal approval letters; monitors status of pending and approved protocols and sends reminders to ensure that approval is timely and current; reports non-compliance and unanticipated events as required to the federal Ofﬁce of Human Research Protections.
oMaintains IRB website and online application form.
oFacilitates revisions and additions to Middlebury’s IRB policy.
2.Institutional Animal Care and Use Committee (IACUC)
oManages protocol and amendment submission and approval process including tracking expiration dates, sending reminders for annual reviews and third year renewals, and documenting post approval monitoring.
oOversees online system of required training for students, staff, and faculty and manages the occupational risk assessment program, coordinating with on-campus and outside health practitioners, assisting students, faculty, and staff through the process, issuing reminders and follow-up notices as needed, and maintaining required documentation.
oCoordinates IACUC meetings, including scheduling, preparation of agenda, packets and meeting minutes and follow-up Maintains the IACUC website, including updates to numerous documents, forms, policies, and procedures related to animal programs and committee operations.
oPrepares reports to the Institutional Ofﬁcial, government agencies and AAALAC and manages license and accreditation renewals and inspections.
3.Institutional Biosafety Committee (IBC).
oMaintains IBC records; maintains the IBC website and keeps its resources current, including the committee roster, biosketches, and the dates, times, and locations of upcoming meetings.
oOrganizes annual IBC meetings, plus others as required by College business; prepares meeting agendas and notes; takes minutes; redacts them as appropriate to share with the public on request; responds to public comments; forwards comments and responses to NIH’s Ofﬁce of Science Policy (OSP).
oCompiles and ﬁles the IBC’s annual report with NIH OSP; provides it to senior administration at Middlebury.
oReports signiﬁcant problems with, or violations of, the NIH Guidelines and any signiﬁcant research-related accidents or illnesses to OSP as required.
oProvides access to rDNA and biological safety training materials.
•Investigates and keeps up-to-date on research compliance laws, policies, and guidelines across institutional lines and sponsoring agencies.
•Serves the administration, the Director of Sciences, researchers, and staff as research compliance expert.
•Monitors developments and changes regarding statutes, rulings, rules, and regulations that affect compliance initiatives, communicates updates, and proposes changes in compliance practices as necessary.
•Maintains accurate and comprehensive records of research compliance activities and other reports as necessary to comply with appropriate regulations.
•Manages compliance with institutional policies on Financial Conﬂict of Interest (FCOI) for grant-funded (sponsored) research.
•Provides support to the institutional ofﬁcial responsible for Middlebury’s Research Misconduct Policy for responding to allegations of misconduct and reporting requirements.
•Develops and delivers educational programs related to research, research compliance and the responsible conduct of research to the Middlebury community.
•Identiﬁes areas of compliance vulnerability, performing risk assessments as necessary.
•Serves as the primary contact for faculty research involving:
oExport controls issues,
oMaterial Transfer Agreements,
oData Use Agreements.
•Manages the Research Compliance budget.
Exercises sound judgment, prioritizes, and manages time effectively, while working effectively under pressure.
Acts as a team player by working collaboratively and demonstrating initiative, creativity, sound judgment, discretion, and leadership.
Handles conﬁdential information in a discreet manner.
Periodically works extended hours, including weekends, in order to meet deadlines or attend conferences.
Performs other related duties as required.
A Bachelor’s degree (BA/BS) and three years of related experience are required. Master’s degree preferred.
Training or experience suitable for serving as Radiation Safety Officer (may be taken after hire).
Training in EPA and DOT requirements needed to be able to authorize or sign hazardous waste manifests.
Intermediate to advanced knowledge of Microsoft Outlook, Excel, and Word software and be familiar with other software products such as Microsoft Access or FileMaker Pro.
Experience in managing animal program compliance, ideally with some level of AALAS certification.
Exceptional organizational skills, attention to detail, and a strong work ethic.
The ability to thrive in a fast-paced environment with high volume production requirements and meet frequent deadlines under minimal supervision.
The ability to express thoughts in a clear, concise, and professional manner, both verbally and in writing, to audiences with widely varying experience in working with compliance issues.
Experience working in a human subject protection compliance position in a higher education setting preferred.Open Until Filled:
YesSpecial Instructions to Applicants:
Offer is contingent upon successful completion of a criminal background check.