Clinical Compliance Specialist

Neurocrine Biosciences • San Diego, CA

2d • $81,000 - $111,000 • Remote

About The Position

Supports Clinical Operations (ClinOps) on efforts related to clinical process compliance, continuous improvement, and inspection readiness activities. Key contributor to other process-related tasks (eg, study-specific training process, NBI consent document template management). Facilitate training and controlled document revisions and serves as ClinOps liaison to help identify and support resolution of procedural gaps and improved ways of working.

Requirements

• BS/BA degree in life science or related field AND 2+ years of experience in Clinical Compliance, Clinical Operations, or related areas within the biopharmaceutical industry.
• Master’s degree in life science or related field AND Some experience as noted above
• Demonstrated understanding of Good Clinical Practices (GCP), regulatory compliance and inspection readiness
• Strong organizational and communication skills, with the ability to work effectively in a team environment and collaborate with internal and external stakeholders
• Proficiency in maintaining controlled documents, managing training activities, and maintaining distribution lists
• Commitment to staying updated on regulatory requirements and standards in the biopharmaceutical industry
• Ability to work as part of a team and independently
• Good project management skills
• Excellent computer skills.
• Working knowledge of clinical operations, specifically conducting clinical studies from start-up through close-out
• Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
• Must have excellent interpersonal skills and excellent communication skills (verbal and written)

Nice To Haves

• Previous experience as a Clinical Trial Specialist or Clinical Research Coordinator, or equivalent, preferred.
• Experience with Veeva Vault preferred

Responsibilities

• Supports study teams on audit/inspection-related activities, by providing guidance on findings and escalating to Clinical Compliance (CC) Sr. Specialist(s), Managers and Directors as needed.
• Acts as ClinOps liaison by providing guidance on clinical processes and Good Clinical Practices (GCP)
• Supports creation and revision of ClinOps controlled documents by generating initial drafts, consolidating comments and scheduling meetings with Subject Matter Experts (SMEs)
• Maintains NBI consent documents templates, and associated documents.
• Supports study teams on SST activities, including maintenance of SST matrix templates, processing of document submissions for SST assignment, under Sr. CC Specialist, Manager(s) and Director(s) guidance
• Assists ClinOps training activities under direction of CC Sr. Specialist(s), Manager(s) and Director(s) (e.g., scheduling live training sessions, managing training records, drafting and distributing training materials)
• Manages CC mailbox, redirecting inquiries to CC Sr. Specialist(s), Manager(s) and Director(s), as needed
• Manages applicable distribution lists (e.g., internal distribution of safety reports from NBI Drug Safety and Pharmacovigilance to study teams)
• Supports ClinOps training curricula review (e.g., retrieves reports for current assignments, obtains current job descriptions, schedules meetings with group leads)
• Participates and promotes collaboration in departmental and cross-departmental meetings, as necessary
• Provides administrative support, including maintenance of CC tools, authoring meeting minutes, and creating reports
• Develops and maintains working relationships with other functional areas outside of Clinical Operations
• Demonstrates knowledge of applicable regulatory requirements, and business standards.
• Constantly maintains knowledge in an on-going manner
• Performs other duties as assigned

Benefits

• retirement savings plan (with company match)
• paid vacation, holiday and personal days
• paid caregiver/parental and medical leave
• health benefits to include medical, prescription drug, dental and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level