Specialist, Clinical Trials
Neurocrine Biosciences
5 hours ago
Remote friendly (San Diego, CA)
United States
Clinical Research and Development
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 IRB/IEC submission and approval procedures from start up through closeout. Collaborates with clinical research colleagues and investigator sites to conduct clinical trials adhering to Good Clinical Practice (GCP), ensuring accurate data, subject safety, and impeccable documentation.
Your Contributions (include, But Are Not Limited To)
- Ensure studies are conducted in compliance with FDA regulations, EU Directive, ICH guidelines, and NBI SOPs/policies (with CTMs)
- 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, escalating issues to CROs/CSPs)
- Participate in study team meetings; track issues; create study timelines (under CTM direction); help with recruitment
- Support internally run studies (monitoring plan updates, on-site monitoring guidelines/forms/tools; may support monitoring visits)
- Document NBI standard processes across clinical programs
- Develop relationships with investigator sites, IRBs/IECs, and CROs to meet trial needs
- Expedite study start-up processes and resolve document quality issues
- Pre-populate essential document templates; create essential document packets
- Coordinate and maintain complete and accurate site essential documents through study duration
- Perform IRB/IEC study-level submissions and manage site submissions to ensure compliance
- Provide clinical document and IRB/IEC status updates to ClinOps
- Develop and review Consent Documents per regulatory requirements and NBI SOPs
- Manage document translation with vendors
- Manage distribution of Dear Investigator Letters
- Support study monitors with outstanding-document updates and eTMF/IRB-IEC questions
- Maintain and QC eTMF documents (organized per CRO/NBI SOPs); perform sponsor oversight eTMF QC/inspection readiness QC; resolve eTMF QC findings
- Ensure eTMF QC follows the TMF Plan schedule (if available)
- Other duties as assigned
Requirements
- BS/BA in a Scientific field (or equivalent) AND 2+ years of clinical trials/operations experience; CRO/Vendor Management exposure preferred; monitoring experience preferred
OR
- Master’s degree in a Scientific field (or equivalent) AND some experience as noted above
- Knowledge of best practices in the functional discipline and familiarity with broader business concepts
- Ability to improve tools/processes in 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 with high accuracy/efficiency
- Developing project management skills
- Ability to analyze data/information to derive options/recommendations
- Working knowledge of the clinical drug development process (ICH, GCP, FDA regulations, EU Directive)
- Working knowledge of clinical operations (start-up through close-out)
- Some trial management protocol/process knowledge
- General understanding of the Clinical Research industry
- Ability to plan activities, manage time effectively, and work well under changing circumstances
Benefits (as stated)
- Annual base salary: $89,800.00–$123,000.00
- Annual bonus target: 20% of earned base salary; eligibility for equity-based long-term incentive program
- Retirement savings plan with company match; paid vacation/holidays/personal days
- Paid caregiver/parental and medical leave
- Health benefits: medical, prescription drug, dental, and vision
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 IRB/IEC submission and approval procedures from start up through closeout. Collaborates with clinical research colleagues and investigator sites to conduct clinical trials adhering to Good Clinical Practice (GCP), ensuring accurate data, subject safety, and impeccable documentation.
Your Contributions (include, But Are Not Limited To)
- Ensure studies are conducted in compliance with FDA regulations, EU Directive, ICH guidelines, and NBI SOPs/policies (with CTMs)
- 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, escalating issues to CROs/CSPs)
- Participate in study team meetings; track issues; create study timelines (under CTM direction); help with recruitment
- Support internally run studies (monitoring plan updates, on-site monitoring guidelines/forms/tools; may support monitoring visits)
- Document NBI standard processes across clinical programs
- Develop relationships with investigator sites, IRBs/IECs, and CROs to meet trial needs
- Expedite study start-up processes and resolve document quality issues
- Pre-populate essential document templates; create essential document packets
- Coordinate and maintain complete and accurate site essential documents through study duration
- Perform IRB/IEC study-level submissions and manage site submissions to ensure compliance
- Provide clinical document and IRB/IEC status updates to ClinOps
- Develop and review Consent Documents per regulatory requirements and NBI SOPs
- Manage document translation with vendors
- Manage distribution of Dear Investigator Letters
- Support study monitors with outstanding-document updates and eTMF/IRB-IEC questions
- Maintain and QC eTMF documents (organized per CRO/NBI SOPs); perform sponsor oversight eTMF QC/inspection readiness QC; resolve eTMF QC findings
- Ensure eTMF QC follows the TMF Plan schedule (if available)
- Other duties as assigned
Requirements
- BS/BA in a Scientific field (or equivalent) AND 2+ years of clinical trials/operations experience; CRO/Vendor Management exposure preferred; monitoring experience preferred
OR
- Master’s degree in a Scientific field (or equivalent) AND some experience as noted above
- Knowledge of best practices in the functional discipline and familiarity with broader business concepts
- Ability to improve tools/processes in 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 with high accuracy/efficiency
- Developing project management skills
- Ability to analyze data/information to derive options/recommendations
- Working knowledge of the clinical drug development process (ICH, GCP, FDA regulations, EU Directive)
- Working knowledge of clinical operations (start-up through close-out)
- Some trial management protocol/process knowledge
- General understanding of the Clinical Research industry
- Ability to plan activities, manage time effectively, and work well under changing circumstances
Benefits (as stated)
- Annual base salary: $89,800.00–$123,000.00
- Annual bonus target: 20% of earned base salary; eligibility for equity-based long-term incentive program
- Retirement savings plan with company match; paid vacation/holidays/personal days
- Paid caregiver/parental and medical leave
- Health benefits: medical, prescription drug, dental, and vision