Clinical Compliance Assistant

4 days ago


San Diego, California, United States Neurocrine Biosciences Full time
About Neurocrine Biosciences

We are a neuroscience-focused, biopharmaceutical company dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, endocrine, and psychiatric disorders. Our diverse portfolio includes FDA-approved treatments for tardive dyskinesia, Parkinson's disease, endometriosis, and uterine fibroids, as well as clinical programs in multiple therapeutic areas.

About the Role

We are seeking a Clinical Compliance Assistant to support our Clinical Compliance team on operational tasks. The successful candidate will be responsible for creating and maintaining Clinical Compliance tools, scheduling meetings and training sessions, coordinating training recording activities, managing training records, drafting training materials, initiating Clinical Compliance documents, creating metric reports, managing email distribution lists, managing the Clinical Compliance mailbox, and redirecting inquiries to Clinical Compliance Specialists, Managers, and Directors as needed.

Responsibilities
  • Support Clinical Compliance team on operational tasks
  • Create and maintain Clinical Compliance tools
  • Schedule Clinical Compliance meetings and training sessions
  • Coordinate training recording activities
  • Manage training records
  • Draft training materials
  • Initiate Clinical Compliance documents
  • Create metric reports
  • Manage email distribution lists
  • Manage Clinical Compliance mailbox and redirect inquiries to Clinical Compliance Specialists, Managers, and Directors as needed
  • Manage Study-Specific Training activities, including maintenance of Study-Specific Training matrix templates and processing of document submission for Study-Specific Training assignment
  • Participate and promote collaboration in departmental and cross-departmental meetings as necessary
  • Develop and maintain working relationships with other functional areas outside of Clinical Operations
  • Perform other duties as assigned
Requirements
  • BS/BA degree in life science or related field or RN
  • Some relevant experience in clinical research or medical field
  • Some knowledge of clinical drug development process, including working knowledge of ICH, Good Clinical Practices (GCPs)
  • Some knowledge of Clinical Operations
  • Some trial management protocol and process knowledge
  • General understanding of Clinical Research industry and the relevant environments in which it operates
  • Clinical terminology and GCPs knowledge
  • Basic knowledge and understanding of applicable regulatory requirements
  • Ability to work as part of a team
  • Good computer skills (MS Office, Smartsheet, SharePoint)
  • Developing communications, problem-solving, analytical thinking, planning, and organization skills

We are an EEO/AA/Disability/Vets employer and are committed to building a diverse, equitable, and inclusive workplace. We recognize that there are a variety of ways to meet our requirements and encourage you to apply even if your experience or qualifications don't line up to exactly what we have outlined in the job description.



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