Specialist, Clinical Trials

Neurocrine Biosciences is a leading biopharmaceutical company dedicated to discovering, developing, and commercializing life-changing treatments for patients with under-addressed neurological, psychiatric, endocrine, and immunological disorders. The company's diverse portfolio includes FDA-approved treatments and a robust pipeline of compounds in mid- to late-phase clinical development. For more than three decades, Neurocrine has applied unique insights into neuroscience to treat complex conditions.

About The Role

Supports the operational activities for planning, initiation, conduct, and close-out of assigned Clinical Studies (domestic and global studies). Key contributor to clinical studies using Contract Research Organizations (CROs) and internally run studies. Manages essential document collection and Institutional Review Board (IRB) and Ethics Committee (IEC) submission and approval procedures from start-up through close-out for assigned trials.

Collaborates with clinical research colleagues within Neurocrine, at CROs, and at Investigator sites to conduct clinical trials adhering to Good Clinical Practice (GCP) and ensuring accurate data, subject safety, and impeccable documentation.

Responsibilities

• Works with Clinical Trial Managers (CTMs) to ensure clinical studies comply with FDA regulations, EU Directive, ICH guidelines, and NBI Standard Operating Procedures (SOPs) and policies.
• Serves as a team member for assigned clinical studies.
• Prepares data/information for technical and study design discussions.
• Provides administrative support, including ensuring invoices are paid, tracking metrics, and addressing issues for CROs and other contract service providers (CSPs).
• Participates in study team meetings and tracks study issues; creates study timelines under CTM direction.
• Assists with recruitment efforts.
• Participates in internally run studies, including updating monitoring plans, documenting on-site monitoring guidelines, and participating in on-site monitoring visits as necessary.
• Documents NBI standard processes across clinical programs.
• Develops relationships with investigator sites, IRBs/IECs, and CROs to ensure trial needs are met.
• Collaborates with CTM and team members to expedite study start-up processes and resolve quality issues with documents.
• Pre-populates essential document templates and creates essential document packets.
• Coordinates site essential document collection and maintains complete and accurate essential documents for the duration of the study.
• Performs IRB/IEC study-level submissions and manages site submissions to ensure compliance throughout assigned trials.
• Provides clinical document and IRB/IEC status updates in team meetings.
• Develops Consent Documents (CDs) and reviews site CDs following regulatory requirements and NBI SOPs.
• Manages the document translation process with vendors.
• Manages distribution of Dear Investigator Letters to clinical sites, IRBs/IECs, and CROs.
• Supports study monitors by providing updates on outstanding documents and addressing eTMF or IRB/IEC-related questions.
• Ensures eTMF documents are maintained in an organized manner per CRO and/or NBI SOPs, policies, and standards.
• Performs sponsor oversight eTMF QC or Inspection Readiness QC within the eTMF system and resolves findings with the study team.
• Ensures eTMF QC is performed according to the schedule outlined in the TMF Plan.
• Performs other duties as assigned.

Requirements

• BS/BA in a scientific field or equivalent AND 2+ years of clinical trials or operations experience; CRO/Vendor Management exposure preferred. Participation in monitoring clinical trials or related experience preferred.
• OR Master’s degree in a scientific field or equivalent AND some experience as noted above.
• Working knowledge of the clinical drug development process, including ICH, Good Clinical Practices (GCPs), FDA regulations, and EU Directive.
• Working knowledge of clinical operations, specifically conducting clinical studies from start-up through close-out.
• Trial management protocol and process knowledge.
• General understanding of the Clinical Research industry and relevant environments.
• Ability to plan activities and work well under changing circumstances; manages time effectively.
• Knowledge of best practices in the functional discipline and familiarity with broader underlying concepts of related business disciplines.
• Works to improve tools and processes within the functional area.
• Ability to work as part of a team.
• Strong computer skills.
• Good communication, problem-solving, and analytical thinking skills.
• Ability to meet multiple deadlines across a project/program with a high degree of accuracy and efficiency.
• Developing project management skills.
• Ability to analyze data and information to derive options/recommendations for management considerations.

Pay

The annual base salary range is $89,800.00–$123,000.00. Individual pay decisions depend on factors such as primary work location, role complexity, job duties, and relevant experience and skills. This position also offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in an equity-based long-term incentive program.

Benefits

• Retirement savings plan with company match.
• Paid vacation, holiday, and personal days.
• Paid caregiver/parental and medical leave.
• Health benefits, including medical, prescription drug, dental, and vision coverage.