Organization:

OCRS - Sr. Staff

Job Summary:

JOB SUMMARY
Manage a comprehensive biological safety program for all research laboratories at Vanderbilt University Medical Center (VUMC) that use infectious microorganisms and/or biohazardous agents.


Department/Unit Summary:

Vanderbilt Environmental Health and Safety (VEHS) mission is to partner with the VUMC/VU community to facilitate and promote safety, health and environmental protection. VEHS accomplishes this task by providing expertise in the following EH&S technical disciplines: radiation safety; occupational safety, emergency preparedness; industrial hygiene; fire and life safety; training; hazardous materials management; and biological safety.

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MAJOR DUTIES AND RESPONSIBILITIES

Lead the Biosafety Section in administration/management of the VUMC Institutional Biosafety Committee (IBC) including:

• Assist research teams with preparing risk assessments for proposed new procedures that will require IBC review and approval.

• Manage all IBC registrations and maintain all IBC documentation.

• Maintain the IBC registration database.

• Set and maintain the IBC registration review schedule.

• Set and maintain the IBC meeting schedule including managing invitations.

• Maintain IBC membership including ensuring appropriate faculty, ad hoc, and community members are on the IBC.

• Prepare all IBC meeting materials including setting the agenda and keeping minutes.

• Prepare IBC registrations for review by the IBC and serve as liaison between research lab and IBC faculty reviewer.

• Maintain all IBC policies.

• Serve as liaison between IBC and regulatory agencies.

• Finalize IBC registrations after review and issue approval letters.

Serve as a voting member of the IBC.

Assist researchers and VUMC with compliance with all applicable standards and regulations under the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC) including:

• Serving as the Biological Safety Officer.

• Managing incident investigations and reporting.

• Managing compliance with select agent program.

• Managing compliance with import permit program.

• Managing compliance with "Biosafety in Microbiological and Biomedical Laboratories (BMBL)".

Maintain an inventory of all infectious, potentially infectious, and genetically engineered microorganisms being used throughout VUMC laboratories.

Provide direct oversight and manage regulatory compliance of all BL3 designated laboratories including:

• Develop and maintain operational profiles for each BSL-3 lab.

• Coordinate with Facilities Management and the BSL-3 Facility Managers to assure that operations and maintenance activities are carried out in accordance with BSL-3 standards of practice including coordination of annual shutdown and recertification activities.

• Provide input to departments and design teams regarding the construction of new, or modification of existing BSL-3 facilities.

• Provide guidance to research teams in developing procedural documents that conform to institutional BSL-3 standards of operations.

• Assist research teams with training and qualification activities required for deeming personnel prepared to work independently at BSL-3.

• Monitor and inspect BSL-3 labs on a periodic basis to determine corrective actions and document compliance with BSL-3 standards of practice.

Work with Occupational Health to develop and implement a comprehensive program to satisfy the requirements of the TOSHA Bloodborne Pathogen Standard including post-exposure evaluations of exposure incidents and thorough training of both researchers and lab workers on their responsibilities.

Oversee and facilitate programs designed to identify the hazards encountered by animal users and to develop facility, user, or investigator-specific plans to address those hazards.

• Serve as an "ex-officio" member of the Animal Use and Care Committee.

• Serve as the OCRS liaison to the Animal Care and Use Program (ACUP), Division of Animal Care (DAC), and the Office of Animal Welfare Assurance (OAWA).

Serve as a member on the Human Subjects IBC.

Work with Occupational Health and Infection control with medical surveillance issues for employees working with HIV and other biohazardous agents.

Assist research laboratories with safety and compliance related to working with and disposing of:

• Recombinant or synthetic nucleic acid molecules.

• Agents infectious to humans, animals, or plants.

• Human-derived materials.

• Non-human primate-derived materials.

• Biological toxins.

Develop and maintain central database of all Biosafety Level designated laboratories and research efforts.

Serve as liaison between VUMC and biosafety-related regulatory agencies including filling specific biosafety-related roles required by regulations such as "Responsible Official" for the select agent program.

Develop, implement, and maintain policies, training, and inspection program to support compliance with items listed above.

Must be capable of passing a Department of Justice/FBI security clearance for access to labs holding Select Agents, as defined by 42 CFR 73, "Possession, Use, and Transfer of Select Agents and Toxins".

Work collaboratively with the Vanderbilt University Biosafety Section in programmatic areas that overlap including the animal research program.

Manage the Biosafety Section including direct supervision of staff, mentoring the professional development of staff, establishing task distribution among staff, and maintaining a strong team mentality.

Supervisory Responsibility

Direct supervision of multiple professional staff members. Indirect supervision of interns, consultants, and vendors.

Budgetary Responsibility

Monitor expenditures against budget. Prepare necessary documentation for supervisory approval.

COMMUNICATION

Internal

Frequent contact with all levels of administration, faculty, and staff including the presentation of information where detailed explanation is required to obtain cooperation and approval.

External

Frequent contact with consultants and vendors. Potential for contact with the general public as VUMC's representative on biosafety matters. Official liaison for biosafety-related regulatory agencies.

Patient/Student Contact

Frequent contact with students as interns or in laboratories. Occasional contact with patients as consultant for HIV and TB patients.

PHYSICAL REQUIREMENTS

There are no unusual physical requirements.

WORKING ENVIROMENT

Frequent exposure to biological and infectious agents, hazardous chemicals, and ionizing radiation.

JOB SPECIFICATIONS

Education/Experience

A Master's degree in microbiology or the biological sciences and five years direct experience in biological safety program development and management are preferred. Two years of direct experience may be substituted for an advanced degree. A STRONG BACKGROUND IN MICROBIOLOGY IS ESSENTIAL.

Licensure/Certification

Professional biosafety certification is desirable.

Job related skills

Applicant must possess excellent written and verbal communication skills for effective report writing, training, and consulting.

Our professional administrative functions include critical supporting roles in information technology and informatics, finance, administration, legal and community affairs, human resources, communications and marketing, development, facilities, and many more.

At our growing health system, we support each other and encourage excellence among all who are part of our workforce. High-achieving employees stay at Vanderbilt Health for professional growth, appreciation of benefits, and a sense of community and purpose.

Core Accountabilities:

* Organizational Impact: Establishes key tactical and operational plans of a sub-function or multiple departments that has longer-term effect on results of the sub-function. * Problem Solving/ Complexity of work: Integrate knowledge and in-depth analysis from several areas to resolve complex problems that are both technical and operational. * Breadth of Knowledge: Applies comprehensive knowledge of professional/technical area and broad management knowledge of other professional areas to carry out objectives. * Team Interaction: Leads multiple departments with a function.

Core Capabilities :

Supporting Colleagues: - Develops Self and Others: Acts upon constructive feedback from all levels of the organization and initiates strategies to develop talent in others. - Builds and Maintains Relationships: Leverages relationships and insight to forecast potential future needs and influence delivery of work to exceed expectations. - Communicates Effectively: Anticipates difference audience concerns, styles and finds mutually beneficial solutions across conflicting and sensitive issues. Delivering Excellent Services: - Serves Others with Compassion: Demonstrates in-depth knowledge of broad-based issues and considers the interests of others to improve satisfaction of services. - Solves Complex Problems: Critically evaluates complex information and identifies trends/risks to make recommendations to improve processes across areas. - Offers Meaningful Advice and Support: Provides ongoing feedback and development discussions to motivate and support team members to maximize performance.Ensuring High Quality: - Performs Excellent Work: Anticipates problems or obstacles which may interfere with quality standards and develops plants to ensure area's quality standards are met. - Ensures Continuous Improvement: Routinely draws upon valuable learning from others, past experiences, and new information to determine key opportunities. - Fulfills Safety and Regulatory Requirements: Develops appropriate corrective actions for unsafe environments in order to ensure operational and safety compliance. Managing Resources Effectively: - Demonstrates Accountability: Identifies potential obstacles to goal achievement and develops solutions to address those obstacles. - Stewards Organizational Resources: Creates the appropriate systems and processes to effectively manage resources. - Makes Data Driven Decisions: Applies in-depth knowledge of data to recommend and implement new approaches to improve decision making capabilities. Fostering Innovation: - Generates New Ideas: Identifies opportunities and leads development of new initiatives that create value across areas. - Applies Technology: Creates the energy and drive for self/others to identify and leverage technology in new, innovative ways to drive greater efficiencies. - Adapts to Change: Anticipates the change process and clearly communicates impact on others/own team(s), assisting them in embracing the change.

Position Qualifications:

Responsibilities:

Certifications:

Work Experience:

Relevant Work Experience

Experience Level:

7 years

Education:

Master's

For a copy of the physical requirements of this position to determine if you can perform the duties with or without an accommodation or to request an accommodation, please contact VUMC Employee Relations at 615-343-4759 or employeerelations.vumc@vumc.org.