Job DescriptionWe have multiple openings for a
Research Compliance Specialist at LLNL. In this role you will provide advanced technical support and scientific expertise in life sciences research compliance in one or more of the following research compliance areas: biosafety, dangerous gain-of-function, international research of concern, animal ethics and/or human subjects research protections and support compliance with all applicable federal, state, local and institutional regulations, policies and procedures. In this role, you will combine scientific and technical expertise with regulatory analysis to support responsible research and institutional compliance. This position reports to the Research Compliance Manager in the Biosciences and Biotechnology Division within the Physical and Life Sciences Directorate.
This position may offer a hybrid schedule, which includes the flexibility to work from home one or more days per week, after a probationary period. The specifics of the hybrid schedule, including the exact number of days required in the office and virtual work options may vary based on the needs of the team and the organization.
You will- Develop and maintain advanced level knowledge of federal regulations applicable to research compliance in the areas of biosafety, dangerous gain-of-function, international research of concern, animal ethics and/or human subjects research protections.
- Provide technical interpretation of regulatory requirements to institutional research compliance programs, policies and procedures.
- Serve as a technical resource for researchers, research compliance staff, and management regarding research compliance requirements.
- Perform advanced level scientific, technical, and regulatory reviews of research compliance protocols to evaluate whether proposed research is in compliance with federal, state and local regulations, institutional policies and accreditation standards.
- Evaluate research objectives, experimental designs, methodologies, procedures and anticipated outcomes to identify potential risks and assess adequacy of safeguards, monitoring and mitigation measures.
- Interpret and apply relevant regulatory frameworks to novel or complex research scenarios and recommend appropriate compliance approaches, escalating novel or precedent-setting issues as appropriate.
- Generate, review, and support the preparation of regulatory reports and documentation for review and submission by the Institutional Official or designated authority.
- Participate in and support regulatory inspections and site visits including serving as a technical point of contact for assigned matters.
- Support investigations of regulatory non-compliance including drafting non-compliance reports and tracking corrective actions under the direction of the Research Compliance Manager or designee.
- Develop and deliver scientifically and technically grounded training, policies and guidance documents tailored to research disciplines and compliance responsibilities.
- Use electronic research administration systems and data analysis tools to maintain accurate records, assess program performance, identify emerging risks and improve compliance practices.
- May provide technical guidance to junior staff, students, or project teams within assigned areas of expertise
- Perform other duties as assigned.
Qualifications- Ability to secure and maintain a U.S. DOE Q-level security clearance which requires U.S. citizenship.
- PhD degree in a relevant scientific, clinical or life sciences research-related discipline (e.g., microbiology, virology, biology, animal science, veterinary science, public health, bioengineering or a closely related field) or equivalent combination of education and related experience.
- Advanced technical foundation in one or more relevant life sciences research areas, such as molecular biology, microbiology or biosafety, animal models and welfare, human research methods and participant protections, biological risk assessment or research security.
- Ability to critically evaluate scientific literature, research protocols, experimental methods, and technical documentation, including identifying methodological limitations and their implications for risk and compliance requirements.
- Demonstrated knowledge of relevant regulatory and ethical frameworks related to research compliance (e.g., NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, PHS Policy, Guide for the Care and Use of Laboratory Animals, Animal Welfare Act regulations, USG Policy for Stopping High-Risk Life Sciences Research, HHS Policy for Protection of Human Subjects) with the ability to research, interpret and apply complex and evolving regulatory requirements within established institutional processes.
- Strong analytical judgement and problem-solving skills, including the ability to assess risk, document defensible recommendations, manage sensitive information and recognize matters requiring escalation or additional expertise.
- Advanced written and verbal communication skills to explain and present complex scientific, technical, and regulatory concepts and provide recommendations to researchers, compliance staff, and management.
- Strong organizational and project-management skills, with the ability to prioritize and execute multiple complex assignments independently with minimal direction.
Qualifications We Desire- Relevant research compliance certification(s), such as Certified Professional IACUC Administrator (CPIA) certification, Certified IRB Professional (CIP) credential, Registered Biosafety Professional (RBP), or Certified Biosafety Professional (CBSP).
- Experience conducting or supporting scientific, technical, or regulatory reviews in one or more assigned research compliance areas.
- Experience developing technical guidance, training, or compliance-related procedures for scientific or research audiences.
- Experience using electronic research administration systems, databases, or data-analysis tools to manage compliance records and identify trends.
Pay Range$175,530 - $222,564 Annually
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting; pay will not be below any applicable local minimum wage. An employee's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, seniority, geographic location, performance, and business or organizational needs.
Additional Information#LI-Hybrid
Position InformationThis is a Career Indefinite position, open to Lab employees and external candidates.
