About the Role:Facilitates Clinical Compliance operational activities, manages the Study-Specific Training (SST) process, and assists with process improvement initiatives under the guidance of the Clinical Compliance Specialist, Manager, or Director.
Your Contributions (include, but are not limited to):- Supports Clinical Compliance (CC) team with operational tasks:
- Develops and maintains CC tools (e.g., trackers)
- Plans and schedules CC meetings and training sessions
- Coordinates training recording activities
- Manages training records
- Drafts training materials
- Initiates CC documents (e.g., templates)
- Compiles metric reports
- Administers email distribution lists
- Manages the CC mailbox and redirects inquiries to CC Specialists, Managers, and Directors as needed
- Manages the Study-Specific Training (SST) activities, including maintenance of SST matrix templates and processing document submissions for SST assignments
- Participates in and promotes collaboration during departmental and cross-departmental meetings as necessary
- Develops and maintains working relationships with other functional areas outside of Clinical Operations
- Performs other duties as assigned
Requirements:- BS/BA degree AND Some experience in Clinical Compliance, Clinical Operations, or related areas within the biopharmaceutical industry. Previous experience as a Clinical Trial Assistant/Associate, or equivalent, preferred
- Applies general knowledge of business developed through education or experience and begins to learn Neurocrine's business
- Has basic knowledge of practices and procedures within own discipline
- Developing skill and abilities with tools used in the job family or discipline
- Has conceptual knowledge of theories and practices and will learn procedures within own functional area
- Ability to work as part of a team
- Good computer skills
- Developing communications, problem-solving, analytical thinking, planning and organization skills
- Detail oriented
- Understands importance of meeting deadlines
- Basic knowledge of Good Clinical Practices (GCP), regulatory compliance and inspection readiness
- Commitment to staying updated on regulatory requirements and standards in the biopharmaceutical industry
- Experience with Veeva Vault preferred
- Basic knowledge of clinical operations
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The hourly rate we reasonably expect to pay is $35.35-$47.34. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 15% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.
