Specialist, Clinical Trials – In House Studies
Neurocrine Biosciences
8 days ago
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 domestic and global clinical studies. Key contributor to studies using 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 investigator sites to conduct trials in compliance with GCP and to ensure accurate data, subject safety, and impeccable documentation.
Your Contributions (include, but are not limited to)
- Assist CTMs to ensure compliance with FDA/EU/ICH and NBI SOPs and policies
- Prepare data/information for technical and study design discussions
- Provide administrative support (invoices, metrics tracking, issues for CRO/CSP)
- Participate in study meetings; track issues; help create timelines; support recruitment
- Support internally run studies (monitoring plan updates; site monitoring guidelines/forms/tools; may co-monitor)
- Document NBI clinical operations processes
- Coordinate with investigator sites, IRBs/IECs, and CROs to meet trial needs
- Expedite study start-up; resolve document quality issues
- Pre-populate essential document templates and create essential document packets
- Coordinate site essential document collection; maintain complete essential documents
- Conduct IRB/IEC study-level submissions and manage site submissions for compliance
- Develop consent documents and review site versions per regulatory requirements and NBI SOPs
- Manage document translation process; distribute Dear Investigator Letters
- Support monitors with outstanding document updates; address eTMF/IRB/IEC questions
- Maintain eTMF organization; perform sponsor oversight eTMF QC/inspection readiness QC; resolve eTMF QC findings
Requirements
- BS/BA in scientific field or equivalent + 2+ years clinical trials/operations experience (CRO/vendor management preferred; monitoring experience preferred) OR Master’s + some related experience
- Knowledge of best practices and functional discipline; ability to improve tools/processes
- Teamwork, strong computer skills, good communications/problem-solving/analytical skills
- Ability to meet multiple deadlines accurately/efficiently; developing project management skills
- Working knowledge of clinical drug development (ICH, GCP, FDA, EU Directive) and clinical operations start-up to closeout
- Some trial management protocol/process knowledge; general understanding of clinical research industry
Supports operational activities for planning, initiation, conduct, and closeout of assigned domestic and global clinical studies. Key contributor to studies using 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 investigator sites to conduct trials in compliance with GCP and to ensure accurate data, subject safety, and impeccable documentation.
Your Contributions (include, but are not limited to)
- Assist CTMs to ensure compliance with FDA/EU/ICH and NBI SOPs and policies
- Prepare data/information for technical and study design discussions
- Provide administrative support (invoices, metrics tracking, issues for CRO/CSP)
- Participate in study meetings; track issues; help create timelines; support recruitment
- Support internally run studies (monitoring plan updates; site monitoring guidelines/forms/tools; may co-monitor)
- Document NBI clinical operations processes
- Coordinate with investigator sites, IRBs/IECs, and CROs to meet trial needs
- Expedite study start-up; resolve document quality issues
- Pre-populate essential document templates and create essential document packets
- Coordinate site essential document collection; maintain complete essential documents
- Conduct IRB/IEC study-level submissions and manage site submissions for compliance
- Develop consent documents and review site versions per regulatory requirements and NBI SOPs
- Manage document translation process; distribute Dear Investigator Letters
- Support monitors with outstanding document updates; address eTMF/IRB/IEC questions
- Maintain eTMF organization; perform sponsor oversight eTMF QC/inspection readiness QC; resolve eTMF QC findings
Requirements
- BS/BA in scientific field or equivalent + 2+ years clinical trials/operations experience (CRO/vendor management preferred; monitoring experience preferred) OR Master’s + some related experience
- Knowledge of best practices and functional discipline; ability to improve tools/processes
- Teamwork, strong computer skills, good communications/problem-solving/analytical skills
- Ability to meet multiple deadlines accurately/efficiently; developing project management skills
- Working knowledge of clinical drug development (ICH, GCP, FDA, EU Directive) and clinical operations start-up to closeout
- Some trial management protocol/process knowledge; general understanding of clinical research industry