Research Support Senior - Biosafety Program Manager

Duties and Responsibilities

(NOTE: ** denotes Essential Functions)

• **Manages implements and administers the system Biosafety Program at the University of Hawaii (UH) to ensure compliance and conformity with all pertinent government regulations and policies.
• **Serves as SME (subject matter expert) on regulatory and compliance issues which involve the use of genetically modified biological materials and other regulated biological materials.
• **Partners with and advises the UH Office of Research Services (ORS) on grant awards and/or initial project proposals to determine conformity and compliance with Institutional Biosafety Committee (IBC) approved protocols.
• **Assembles and authors annual progress reports to UH leadership on the status of the biosafety program with regard to research and training activities protocol review counts facility inspections personnel training and permit applications.
• **Oversees and ensures the proper evaluation review and audit of new and established facilities and programs using biological materials in the UH system for conformance with IBC procedures. Establishes corrective parameters as warranted by federal and/or state regulation.
• **Directs initiates and conduct investigations into complaints and alleged noncompliant activities which involve the use of biological materials used in research and teaching.
• **Serves as the Universitys Executive Secretary to the IBC. Including: formulation/ of policies administrative protocol reviews to ensure conformity with the Office of Science and Technology Policy (OSTP) National Institutes of Health (NIH) Centers for Disease Control and Prevention (CDC) and Occupational Safety and Health Administration (OHSA) regulations as described in the IBC Operating Policy and Procedures managing the electronic system used to submit and review IBC protocols (Topaz) and interagency correspondences on behalf of UH.
• **Networks collaborates and coordinates oversight activities with other UH compliance offices subject matter experts or representatives from other academic research institutions and government branches to exchange ideas on complex issues or problems.
• **Advises guides and interfaces with various UH departments faculty students and nonaffiliated UH agencies on matters which impact the IBC and stakeholders to prevent and resolve compliance issues.
• **Serves as Liaison with federal and state regulatory agencies and provides periodic updates and recommended actions to senior management as issues require institutional response.
• **Develops drafts and provides strategic direction and support to the Institutional Official in the preparation of reports to oversight agencies renewals of assurances and management of local policies and procedures.
• Partners with the UH Office of General Counsel (OGC) on matters of institutional policies (e.g. release of committee records sensitive/classified information agreements) affecting biological materials research and compliance.
• **Develops policies procedures and expectations consistent with industry standards and institutional needs with regard to microorganisms genetically modified biological materials and commodities used in research and teaching.
• **Disseminates introduces and provide updates to administration investigators and personnel on regulatory matters (e.g. developing/approved federal/state legislation recently enacted laws regulations/updates and funding agency new policies). Provides direction to ensure research requirements are clearly communicated and work with IT specialists to keep the biosafety program website current.
• **Directs supervises and manages a subordinate staff of professionals including subject matter experts and technical and clerical personnel in executing program assignments and work details.
• **Develops administers and controls operation budgets which may include Research and Training Revolving Fund (RTRF) and Research Corporation of the University of Hawaii (RCUH) accounts to support the activities of the program and IBC. Consult with executives on the management of longrange planning to address both current and anticipated needs of the Institutions compliance program.
• **Develops administers and controls cooperative agreements which define relationships and expectations for those nonaffiliated clientele who utilize the UH IBC for protocol review and oversight.
• Other Duties as Assigned

Minimum Qualifications

Education and Professional Work Experience

• Possession of a baccalaureate degree in science biological and health sciences occupational health and safety environmental health or related field and 9 year(s) of progressively responsible professional experience with responsibilities for regulatory compliance; or any equivalent combination of education and/or professional work experience which provides the required education knowledge skills and abilities as indicated.

Knowledge Skills and Abilities

• Advanced and comprehensive knowledge and understanding of a wide range of developing and emerging concepts principles and methodologies in the area of research safety and compliance.
• Comprehensive knowledge and understanding of a wide range of principles theories federal and state laws and systems associated with research safety and compliance.
• Demonstrated ability to understand problems from a broad interactive perspective and use reasoning to discern underlying principles and issues when problem solving and apply creative thinking to resolve problems in new and innovative approaches.
• Demonstrated written and verbal competence in presenting ideas concepts and models clearly using persuasion and negotiation to build consensus and cooperation.
• Demonstrated ability to establish and maintain effective working relationships with internal and external organizations groups team leaders and members and individuals.
• Demonstrated ability to operate a personal computer apply word processing software proficiency in Microsoft Office and Adobe applications.
• For supervisory work demonstrated ability to lead subordinates manage work priorities and projects and manage employee relations.

• Proven ability to identify and resolve complex safety and/or regulatory compliance issues in a timely manner.
• Proven experience in designing and delivering training programs for staff on biosafety regulatory compliance and/or laboratory safety protocols.
• Experience in developing and managing budgets related to safety and/or laboratory operations.
• Demonstrated strong analytical skills to interpret data related to safety incidents and compliance trends and the ability to generate comprehensive reports.
• Demonstrated commitment to maintaining high ethical standards and integrity in all aspects of safety and regulatory compliance.

Desirable Qualifications

• Possession of a Masters degree or equivalent collegelevel coursework in regulatory compliance or a closely related field.
• Professional certification in biosafety occupational health or related training.
• Experience in supervising administrative operations within a university setting.
• Five or more years of biological laboratory research experience.
• Experience managing or overseeing a Biosafety Level 3 Laboratory.
• Experience working with Topaz Software Management System.

To Apply:

Click on the Apply button on the top right corner of the screen to complete an application and upload required documents. Required documents include: 1 cover letter indicating how you satisfy the minimum and desirable qualifications; 2 resume; 3 the names and contact information of at least three professional references; and 4 transcripts showing degree and coursework to date appropriate to the position (original official transcripts will be required at the time of hire. NOTE: Please create a new account if this is your first time applying for a position using NEOGOV.

Inquiries:

Diana Blanco Director of Office of Research Compliance; email: