Clinical Compliance Specialist
Neurocrine Biosciences
14 hours ago
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About The Role
Supports Clinical Operations (ClinOps) on clinical process compliance, continuous improvement, and inspection readiness. Key contributor to process-related tasks (e.g., study-specific training process, NBI consent document template management). Facilitates training and controlled document revisions and serves as ClinOps liaison to identify/support resolution of procedural gaps and improve ways of working.
Your Contributions (include, But Are Not Limited To)
- Support study teams on audit/inspection activities by guiding teams on findings and escalating to Clinical Compliance (CC) as needed; provide guidance on clinical processes and Good Clinical Practices (GCP)
- Create and revise ClinOps controlled documents (drafts, consolidate comments, schedule SME meetings)
- Maintain NBI consent document templates and associated documents
- Assist ClinOps training activities under direction of CC (schedule live training, manage training records, draft/distribute materials)
- Manage CC mailbox (redirect inquiries as needed)
- Manage distribution lists (e.g., distribute safety reports from Drug Safety/Pharmacovigilance to study teams)
- Support ClinOps training curricula review (retrieve reports, obtain current job descriptions, schedule meetings)
- Participate in departmental/cross-departmental meetings; provide administrative support (maintain CC tools, author minutes, create reports)
- Develop maintain working relationships outside Clinical Operations; demonstrate ongoing knowledge of applicable regulatory requirements and business standards
- Perform other duties as assigned
Requirements
- BS/BA in life science or related field + 2+ years in Clinical Compliance/Clinical Operations/related biopharma roles; Clinical Trial Specialist/Clinical Research Coordinator experience preferred OR Master’s + some related experience
- Demonstrated understanding of GCP, regulatory compliance, and inspection readiness
- Strong organizational and communication skills; ability to work with internal/external stakeholders
- Proficiency maintaining controlled documents, training activities, and distribution lists
- Commitment to staying updated on regulatory requirements
- Ability to work independently and in a team
- Good project management skills
- Excellent computer skills (Veeva Vault preferred)
- Working knowledge of clinical operations from start-up through close-out
- Meet multiple deadlines with accuracy and efficiency
- Excellent interpersonal skills and verbal/written communication
Supports Clinical Operations (ClinOps) on clinical process compliance, continuous improvement, and inspection readiness. Key contributor to process-related tasks (e.g., study-specific training process, NBI consent document template management). Facilitates training and controlled document revisions and serves as ClinOps liaison to identify/support resolution of procedural gaps and improve ways of working.
Your Contributions (include, But Are Not Limited To)
- Support study teams on audit/inspection activities by guiding teams on findings and escalating to Clinical Compliance (CC) as needed; provide guidance on clinical processes and Good Clinical Practices (GCP)
- Create and revise ClinOps controlled documents (drafts, consolidate comments, schedule SME meetings)
- Maintain NBI consent document templates and associated documents
- Assist ClinOps training activities under direction of CC (schedule live training, manage training records, draft/distribute materials)
- Manage CC mailbox (redirect inquiries as needed)
- Manage distribution lists (e.g., distribute safety reports from Drug Safety/Pharmacovigilance to study teams)
- Support ClinOps training curricula review (retrieve reports, obtain current job descriptions, schedule meetings)
- Participate in departmental/cross-departmental meetings; provide administrative support (maintain CC tools, author minutes, create reports)
- Develop maintain working relationships outside Clinical Operations; demonstrate ongoing knowledge of applicable regulatory requirements and business standards
- Perform other duties as assigned
Requirements
- BS/BA in life science or related field + 2+ years in Clinical Compliance/Clinical Operations/related biopharma roles; Clinical Trial Specialist/Clinical Research Coordinator experience preferred OR Master’s + some related experience
- Demonstrated understanding of GCP, regulatory compliance, and inspection readiness
- Strong organizational and communication skills; ability to work with internal/external stakeholders
- Proficiency maintaining controlled documents, training activities, and distribution lists
- Commitment to staying updated on regulatory requirements
- Ability to work independently and in a team
- Good project management skills
- Excellent computer skills (Veeva Vault preferred)
- Working knowledge of clinical operations from start-up through close-out
- Meet multiple deadlines with accuracy and efficiency
- Excellent interpersonal skills and verbal/written communication