Clinical Trials Operations Specialist

Latigo Bio; Thousand Oaks (CA); Hybrid; USD 65,000 - 75,000; Full time

Job summary

Latigo Bio is seeking a Clinical Trial Associate to provide operational and administrative support for Latigo-sponsored trials. You will assist with start-up, maintenance, and close-out activities, manage eTMF and study documents, coordinate meetings, and support trial systems.

You will work with cross-functional teams, vendors, and trial sites to ensure compliance with ICH-GCP, regulatory requirements, and study plans, while maintaining strong organizational discipline and effective

Qualifications

• Bachelor’s degree or equivalent in a scientific discipline or health-related field.
• Minimum of 2 years of relevant industry experience.
• Working knowledge of clinical trial conduct, start-up, maintenance, and close-out activities.
• Familiarity with ICH-GCP, CFR, and other regulatory requirements.
• Experience supporting Trial Master File activities preferred.
• Strong organizational skills, attention to detail, and ability to manage multiple priorities.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook, Teams).
• Ability to collaborate with internal study teams and vendors.
• Follow established processes, escalate issues, and support timely resolution.

Responsibilities

• Assist with study start-up activities and eTMF setup, collect and track essential documents.
• Oversee eTMF maintenance and perform interim quality checks.
• Organize and maintain the internal study SharePoint site.
• Maintain study trackers, contact lists, meeting minutes, and action item logs.
• Schedule meetings, prepare agendas, draft minutes, and track follow-up items.
• Support clinical trial systems and portals, including access requests and uploads.
• Review and reconcile study documents, site correspondence, monitoring docs, and vendor deliverables.
• Coordinate logistics for investigator meetings and vendor meetings.
• Track milestones, deliverables, risks, issues, and decisions; escalate delays.
• Support backroom operations during regulatory inspections.
• Track invoices, budgets, contracts, and work orders.
• Maintain awareness of applicable clinical research regulations and SOPs.
• Perform other clinical operations duties as assigned.

Skills

Organizational skills

Attention to detail

Communication skills

Multitasking

Collaboration

Education

Bachelor’s degree in a scientific discipline

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Outlook

Teams

Job description

Latigo Bio is seeking a Clinical Trial Associate to provide operational and administrative support for Latigo-sponsored trials. You will assist with start-up, maintenance, and close-out activities, manage eTMF and study documents, coordinate meetings, and support trial systems.

You will work with cross-functional teams, vendors, and trial sites to ensure compliance with ICH-GCP, regulatory requirements, and study plans, while maintaining strong organizational discipline and effective