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About the Role
Latigo is seeking a Clinical Trial Associate to provide operational and administrative support for clinical trials. This role supports study start-up, maintenance, and close-out activities, including document tracking, Trial Master File support, meeting coordination, vendor and site communication, and study systems support. The associate will work closely with clinical trial leads and cross-functional team members, vendors, and trial sites to ensure trials are conducted in accordance with protocols, SOPs, ICH-GCP, and regulatory requirements.
Responsibilities
- Assist with study start-up activities, including eTMF index/structure review, eTMF set-up, collection and tracking of essential documents, site contact information, regulatory documents, training documentation, and review of study-specific materials.
- Oversee the maintenance of the electronic Trial Master File (eTMF) for assigned studies, ensuring timely and accurate filing by the CRO and performing interim quality checks.
- Organize and maintain the internal study Sharepoint site for assigned studies.
- Maintain study trackers, contact lists, meeting action item logs, training trackers, vendor trackers, and other study management tools.
- Schedule study meetings, prepare agendas, draft meeting minutes, distribute follow-up items, and track action items through resolution.
- Support clinical trial systems and portals, including access requests, user tracking, document uploads, and follow-up on system-related issues.
- Assist with review and reconciliation of study documents, site correspondence, monitoring documentation, safety-related documentation, and vendor deliverables.
- Coordinate logistics for investigator meetings, study team meetings, site training, vendor meetings, and other clinical trial activities.
- Assist with tracking clinical trial milestones, deliverables, risks, issues, and decisions, escalating delays or issues to the Clinical Trial Manager or study lead.
- Support backroom operations during regulatory inspections.
- Support invoice, budget, contract, and work order tracking.
- Maintain awareness of applicable clinical research regulations, ICH-GCP guidelines, study protocols, SOPs, and project-specific plans.
- Perform other clinical operations duties as assigned.
Requirements
- Bachelor’s degree or equivalent, preferably in a scientific discipline or health-related field.
- Minimum of 2 years of relevant industry experience.
- Working knowledge of clinical trial conduct, study start-up, maintenance, and close-out activities.
- Familiarity with ICH-GCP, CFR, and other applicable regulatory requirements for clinical trial conduct.
- Experience supporting Trial Master File activities preferred.
- Strong organizational skills, attention to detail, and ability to manage multiple priorities in a fast-paced, cross-functional environment.
- Excellent written and verbal communication skills.
- Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and Teams.
- Ability to collaborate effectively with internal study teams and vendors.
- Demonstrated ability to follow established processes, identify issues, escalate appropriately, and support timely resolution of action items.
Skills
- eTMF
- Trial Master File
- Sharepoint
- Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, Teams)
- Clinical trial conduct
- Study start-up
- Study maintenance
- Study close-out
- ICH-GCP
- Regulatory requirements
- Communication skills
- Organizational skills
- Attention to detail
- Collaboration
Location
- Thousand Oaks, CA
- San Francisco, CA
Work Type
- Hybrid
- Office-based
- Occasional travel
Experience Level
- Minimum of 2 years of relevant industry experience
Education Level
- Bachelor’s degree or equivalent, preferably in a scientific discipline or health-related field
About the Company
- Latigo is seeking a highly organized and detailed oriented Clinical Trial Associate to provide operational and administrative support for Latigo-sponsored clinical trials.