Specialist, Clinical Trials
Neurocrine Biosciences
June 26, 2026
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About The Role
- Supports operational activities for planning, initiation, conduct, and closeout of assigned clinical studies (domestic and global).
- Contributes to studies using Contract Research Organizations (CROs) and internally run studies.
- Manages essential document collection and IRB/IEC submission and approval procedures from start-up through closeout.
- Collaborates with clinical research colleagues, CROs, and investigators to conduct trials in accordance with GCP while ensuring accurate data, subject safety, and impeccable documentation.
Your Contributions
- Work with Clinical Trial Managers (CTMs) to ensure compliance with FDA regulations, EU Directive, ICH guidelines, and NBI SOPs/policies.
- Prepare data/information for technical and study design discussions.
- Provide administrative support (e.g., invoices, metrics, issues for CROs/CSPs).
- Participate in study team meetings; track issues; help create study timelines and support recruitment.
- Support internally run studies (monitoring plan updates, on-site monitoring guidance/forms/tools; may co-monitor).
- Document NBI standard processes across clinical programs.
- Coordinate site essential document collection; maintain complete essential documents.
- Perform IRB/IEC study-level submissions and manage site submissions for ongoing compliance.
- Develop and review consent documents per regulatory requirements and NBI SOPs.
- Manage document translation; distribute Dear Investigator Letters.
- Support monitors with document/eTMF/IRB-IEC questions.
- Maintain organized eTMF documents; perform eTMF QC/inspection readiness QC and resolve QC findings.
- Perform eTMF QC per TMF Plan schedule (if available).
Requirements
- BS/BA in scientific field (or equivalent) + 2+ years clinical trials/operations experience (CRO/vendor management preferred; monitoring experience preferred) OR Master’s degree with relevant experience.
- Working knowledge of clinical drug development; ICH, GCP, FDA regulations, and EU Directive.
- Working knowledge of clinical operations from start-up through closeout.
- Some trial management protocol/process knowledge; general clinical research industry knowledge.
- Planning/time-management, teamwork, strong computer skills, and strong communication/problem-solving/analytical thinking.
- Ability to meet multiple deadlines with high accuracy/efficiency; developing project management skills; ability to analyze data to derive options/recommendations.
- Supports operational activities for planning, initiation, conduct, and closeout of assigned clinical studies (domestic and global).
- Contributes to studies using Contract Research Organizations (CROs) and internally run studies.
- Manages essential document collection and IRB/IEC submission and approval procedures from start-up through closeout.
- Collaborates with clinical research colleagues, CROs, and investigators to conduct trials in accordance with GCP while ensuring accurate data, subject safety, and impeccable documentation.
Your Contributions
- Work with Clinical Trial Managers (CTMs) to ensure compliance with FDA regulations, EU Directive, ICH guidelines, and NBI SOPs/policies.
- Prepare data/information for technical and study design discussions.
- Provide administrative support (e.g., invoices, metrics, issues for CROs/CSPs).
- Participate in study team meetings; track issues; help create study timelines and support recruitment.
- Support internally run studies (monitoring plan updates, on-site monitoring guidance/forms/tools; may co-monitor).
- Document NBI standard processes across clinical programs.
- Coordinate site essential document collection; maintain complete essential documents.
- Perform IRB/IEC study-level submissions and manage site submissions for ongoing compliance.
- Develop and review consent documents per regulatory requirements and NBI SOPs.
- Manage document translation; distribute Dear Investigator Letters.
- Support monitors with document/eTMF/IRB-IEC questions.
- Maintain organized eTMF documents; perform eTMF QC/inspection readiness QC and resolve QC findings.
- Perform eTMF QC per TMF Plan schedule (if available).
Requirements
- BS/BA in scientific field (or equivalent) + 2+ years clinical trials/operations experience (CRO/vendor management preferred; monitoring experience preferred) OR Master’s degree with relevant experience.
- Working knowledge of clinical drug development; ICH, GCP, FDA regulations, and EU Directive.
- Working knowledge of clinical operations from start-up through closeout.
- Some trial management protocol/process knowledge; general clinical research industry knowledge.
- Planning/time-management, teamwork, strong computer skills, and strong communication/problem-solving/analytical thinking.
- Ability to meet multiple deadlines with high accuracy/efficiency; developing project management skills; ability to analyze data to derive options/recommendations.