Specialist, Clinical Trials
Neurocrine Biosciences
August 15, 2026
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
About The Role
Supports planning, initiation, conduct and closeout of assigned Clinical Studies (domestic and global). Manages essential document collection and IRB/IEC submission and approval procedures from start-up through closeout. Collaborates with clinical colleagues, CROs, and investigator sites to conduct trials in accordance with GCP and to ensure accurate data, subject safety, and documentation.
Your Contributions (include, but are not limited to)
- Ensure clinical studies comply with FDA regulations, EU Directive, ICH guidelines, and NBI SOPs/policies.
- Serve as a team member for assigned clinical studies.
- Prepare data/information for technical and study design discussions.
- Provide administrative support (e.g., invoice/payment tracking, metrics tracking, issues for CROs/CSPs).
- Participate in study team meetings; track issues; create study timelines (under CTM direction); support recruitment efforts.
- Support internally run studies (update monitoring plans; document on-site monitoring guidelines/forms/tools; may assist with site monitoring).
- Coordinate site essential document collection and maintain complete/accurate essential documents.
- Perform IRB/IEC study-level submissions and manage site submissions to ensure compliance.
- Develop/review Consent Documents per regulatory requirements and NBI SOPs.
- Manage translation process; distribute Dear Investigator Letters.
- Support monitors with updates on outstanding documents and eTMF/IRB-IEC questions.
- Maintain eTMF organization; perform sponsor oversight eTMF QC/inspection readiness QC; resolve QC findings.
Requirements
- BS/BA in a scientific field (or equivalent) + 2+ years clinical trials/operations experience (CRO/vendor management preferred; monitoring experience preferred). OR Master’s degree (or equivalent) + some related experience.
- Working knowledge of clinical drug development; ICH, GCP, FDA regulations, EU Directive.
- Working knowledge of clinical operations from start-up through close-out.
- Some trial management/protocol process knowledge.
- General understanding of clinical research industry environments.
- Ability to plan, manage changing priorities, meet multiple deadlines, strong computer skills, and good communication/problem-solving/analytical skills.
- Ability to work in a team; developing project management skills.
Benefits (if applicable)
- Annual bonus (target 20%) and eligibility for equity-based long-term incentive; retirement savings plan (match); paid vacation/holidays/personal days; paid caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision).
Application instructions
- Not specified.
Supports planning, initiation, conduct and closeout of assigned Clinical Studies (domestic and global). Manages essential document collection and IRB/IEC submission and approval procedures from start-up through closeout. Collaborates with clinical colleagues, CROs, and investigator sites to conduct trials in accordance with GCP and to ensure accurate data, subject safety, and documentation.
Your Contributions (include, but are not limited to)
- Ensure clinical studies comply with FDA regulations, EU Directive, ICH guidelines, and NBI SOPs/policies.
- Serve as a team member for assigned clinical studies.
- Prepare data/information for technical and study design discussions.
- Provide administrative support (e.g., invoice/payment tracking, metrics tracking, issues for CROs/CSPs).
- Participate in study team meetings; track issues; create study timelines (under CTM direction); support recruitment efforts.
- Support internally run studies (update monitoring plans; document on-site monitoring guidelines/forms/tools; may assist with site monitoring).
- Coordinate site essential document collection and maintain complete/accurate essential documents.
- Perform IRB/IEC study-level submissions and manage site submissions to ensure compliance.
- Develop/review Consent Documents per regulatory requirements and NBI SOPs.
- Manage translation process; distribute Dear Investigator Letters.
- Support monitors with updates on outstanding documents and eTMF/IRB-IEC questions.
- Maintain eTMF organization; perform sponsor oversight eTMF QC/inspection readiness QC; resolve QC findings.
Requirements
- BS/BA in a scientific field (or equivalent) + 2+ years clinical trials/operations experience (CRO/vendor management preferred; monitoring experience preferred). OR Master’s degree (or equivalent) + some related experience.
- Working knowledge of clinical drug development; ICH, GCP, FDA regulations, EU Directive.
- Working knowledge of clinical operations from start-up through close-out.
- Some trial management/protocol process knowledge.
- General understanding of clinical research industry environments.
- Ability to plan, manage changing priorities, meet multiple deadlines, strong computer skills, and good communication/problem-solving/analytical skills.
- Ability to work in a team; developing project management skills.
Benefits (if applicable)
- Annual bonus (target 20%) and eligibility for equity-based long-term incentive; retirement savings plan (match); paid vacation/holidays/personal days; paid caregiver/parental and medical leave; health benefits (medical, prescription drug, dental, vision).
Application instructions
- Not specified.