Ibc/Ire Program Coordinator - Active Security Clearance Required

Company Description

Join us and make YOUR mark on the World!

Are you interested in joining some of the brightest talent in the world to strengthen the United States' security? Come join Lawrence Livermore National Laboratory (LLNL) where our employees apply their expertise to create solutions for BIG ideas that make our world a better place.

We are committed to a diverse and equitable workforce with an inclusive culture that values and celebrates the diversity of our people, talents, ideas, experiences, and perspectives. This is important for continued success of the Laboratory's mission.

Pay Range

$107,550 - $133,524 Annually

Please note that the pay range information is a general guideline only. Many factors are taken into consideration when setting starting pay including education, experience, the external labor market, and internal equity

Job Description

We have an opening for an Institutional Biosafety Committee (IBC)/Institutional Review Entity (IRE) Program Coordinator at LLNL. In this role you will provide broad oversight for the LLNL IBC and Dual Use Research of Concern (DURC) Programs and ensure compliance with all Federal, state, local and institutional regulations, policies and procedures. You will work closely with the IBC Chair, Institutional Contact for Dual Use Research (ICDUR) and Biosafety & Biogovernance Functional Area Manager (BBFAM) to define, analyze, implement, and make recommendations for continuous improvement of IBC and IRE business processes. As the IBC/IRE Program Coordinator you will conduct technical and administrative reviews of IBC and IRE protocols, organize and support IBC/IRE committee meetings, develop and implement strategies for addressing process gaps in operations of the IBC/IRE Program office, streamline existing and develop new business operations policies and procedures, conduct outreach and training to the regulated community, and serve as a backup to the IACUC/IRB Program Coordinator. This position is in the Biosafety and Biogovernance Functional Area within the Environment, Safety and Health (ES&H) Directorate and reports to the Biosafety & Biogovernance Functional Area Manager.

You will

• Independently develop, implement and manage highly efficient business processes for end-to-end IBC and IRE protocol review cycle and workflow including serving as a technical resource for assisting researchers as they complete and submit protocols for review, identify activities requiring IBC and/or IRE review, perform rigorous preliminary administrative and technical reviews of submitted protocols, determine appropriate level/type of review for IBC and IRE protocols, and manage the full review and approval process.

• Ensure full compliance with all local, state, and federal regulations regarding work with biological materials, recombinant/synthetic nucleic acids, and dual use research of concern including coordinating and participating in audits and inspections by federal or state regulators and maintaining detailed records of all IBC and DURC regulatory compliance related activities.

• Contribute to the development and maintenance of data-driven performance measures and metrics to accurately reflect the health of the IBC and IRE program business operations.

• Work cross-functionally with the IACUC/IRB Program Coordinator to identify and evaluate overlapping business operations and collaboratively develop efficient, controlled, and documented business processes.

• Generate, review, and submit regulatory reports (e.g., annual NIH Report, semi-annual USG DURC Inventory Report, annual DOE biological etiologic agent inventory report) on behalf of the Institutional Official (IO), IBC Chair, and LLNL IBC and DURC Programs.

• Coordinate and support IBC and IRE meetings including scheduling meetings, preparing meeting packets, ensuring quorum for protocol reviews at convened meetings, taking notes and preparing meeting minutes, and communicating protocol review outcomes to Principal Investigators (PIs).

• Coordinate and participate in investigations of regulatory non-compliance including assisting the IBC Chair and BBFAM with drafting, filing, and submitting non-compliance reports to appropriate regulatory agencies and providing guidance and oversight to ensure corrective actions are completed.

• Lead the triennial NIH IBC Program Self-Assessment including preparing draft reports and submitting to the IBC for review, consolidating reviews/edits, and preparing final reports for submission to the BBFAM and IO.

• Ensure IBC and IRE committees are staffed and trained per regulations including recruiting new IBC members, developing, and providing orientation/training for new committee members, developing and providing ongoing education to committee members, and developing/providing outreach education to the broader LLNL community regarding the breadth of the IBC.

Qualifications

• This position requires an active Department of Energy (DOE) Q-level clearance or active Top Secret clearance issued by another U.S. government agency at the time of hire.

• Bachelor's degree in a relevant functional discipline or equivalent combination of education and related experience.

• Experience in IBC program administration, including development of effective and efficient business processes for IBC protocol management, documentation of business processes, and development and delivery of training on business operations.

• Significant experience and knowledge of federal laws, policies, and regulations governing research with biological materials (e.g., NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, USG Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, 10 CFR 851 Appendix A, Section 7 - Worker Safety & Health Functional Area - Biological Safety).

• Experience assessing current business processes and workflows for efficiency and developing and implementing improved business solutions. Experience developing business process documentation and training materials.

• Proficient verbal and written communication skills necessary to effectively collaborate in a multi-disciplinary team environment and present and explain technical and operational information.

• Exceptional organizational and project management skills, including the ability to plan, schedule, and successfully carry out multiple projects at the same time with minimal supervision.

Qualifications We Desire

• Working knowledge of and previous experience in IACUC and IRB program administration and operations.

• Significant experience in developing and managing protocol review/approval workflows using Microsoft Teams.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Position Information

This is a Career Indefinite position, open to Lab employees and external candidates.

Why Lawrence Livermore National Laboratory?

• Included in 2024 Best Places to Work by Glassdoor!

• Flexible Benefits Package

• 401(k)

• Relocation Assistance

• Education Reimbursement Program

• Flexible schedules (*depending on project needs)

• Inclusion, Diversity, Equity and Accountability (IDEA) - visit https://www.llnl.gov/diversity

• Our core beliefs - visit https://www.llnl.gov/diversity/our-values

• Employee engagement - visit https://www.llnl.gov/diversity/employee-engagement

Security Clearance

This position requires an active Department of Energy (DOE) Q-level clearance or active Top Secret clearance issued by another U.S. government agency at time of hire.

Pre-Employment Drug Test

External applicant(s) selected for this position must pass a post-offer, pre-employment drug test. This includes testing for use of marijuana as Federal Law applies to us as a Federal Contractor.

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Equal Employment Opportunity

We are an equal opportunity employer that is committed to providing all with a work environment free of discrimination and harassment. All qualified applicants will receive consideration for employment without regard to race, color, religion, marital status, national origin, ancestry, sex, sexual orientation, gender identity, disability, medical condition, pregnancy, protected veteran status, age, citizenship, or any other characteristic protected by applicable laws.

We invite you to review the Equal Employment Opportunity posters which include EEO is the Law and Pay Transparency Nondiscrimination Provision.

Reasonable Accommodation

Our goal is to create an accessible and inclusive experience for all candidates applying and interviewing at the Laboratory. If you need a reasonable accommodation during the application or the recruiting process, please use our online form to submit a request.

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