Research Compliance Specialist
Core
Provide advanced technical support and scientific expertise in life sciences research compliance, ensuring adherence to federal, state, local, and institutional regulations across biosafety, gain-of-function, international research, animal ethics, and human subjects research.
Role type
Senior IC research compliance specialist (life sciences)
Builds
Institutional research compliance programs, policies, and procedures
Domain
Life sciences research compliance and regulatory affairs
Deliverable
dashboards & analysis
Required skills
Regulatory analysis, risk assessment, scientific protocol review, training development, electronic research administration systems, complex regulatory interpretation, documentation generation, stakeholder consultation
Preferred skills
Relevant research compliance certifications (CPIA, CIP, RBP, CBSP), experience with electronic research administration systems, experience developing technical guidance
Technologies
Electronic research administration systems, data analysis tools
Responsibilities
Develop and maintain advanced knowledge of federal regulations; Provide technical interpretation of regulatory requirements; Perform advanced scientific, technical, and regulatory reviews of research protocols; Evaluate research objectives and experimental designs to identify risks; Generate and support regulatory reports; Participate in regulatory inspections and site visits; Support investigations of regulatory non-compliance; Develop and deliver training and guidance documents
Seniority
Senior, hands-on IC