Early-Phase Clinical Trial Operations Specialist

Latigo Bio; Thousand Oaks (CA); Hybrid; USD 70,000 - 90,000; Full time

Job summary

Latigo Bio is seeking a highly organized Clinical Trial Associate to provide operational and administrative support for Latigo-sponsored trials. This role supports start-up, maintenance, and close-out activities, including eTMF set-up, document tracking, meeting coordination, and site and vendor communications.

The candidate will work with clinical trial leads and cross-functional teams to ensure adherence to study plans, ICH-GCP, CFRs, and regulatory requirements.

Qualifications

• Bachelor’s degree or equivalent, preferably in a scientific discipline or health-related field.
• Minimum of 2 years of relevant industry experience and familiarity with clinical trial processes.
• 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 (Word, Excel, PowerPoint, Outlook, Teams).

Responsibilities

• Assist with study start-up activities, including eTMF index/structure review and set-up, collection and tracking of essential documents, site contact information, regulatory documents, training documentation, and review of study materials.
• Oversee the maintenance of the electronic Trial Master File (eTMF) for all assigned studies, ensure timely and accurate filing by the CRO, and perform interim quality checks.
• Organize and maintain the internal study Sharepoint site and maintain study trackers, contact lists, meeting action item logs, training trackers, vendor trackers, and other study management tools.
• Schedule study meetings, prepare agendas, draft 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, and vendor meetings.
• Track clinical trial milestones, deliverables, risks, issues, and decisions; escalate delays or issues as needed.
• Support backroom operations during regulatory inspections and handle invoice, budget, contract, and work order tracking.
• Maintain awareness of applicable clinical research regulations, ICH-GCP guidelines, study protocols, SOPs, and project-specific plans.

Skills

Organizational skills

Attention to detail

Communication skills

Multitasking

Team collaboration

Microsoft Office

Education

Bachelor’s degree or equivalent

Tools

Microsoft Office

Job description

Latigo Bio is seeking a highly organized Clinical Trial Associate to provide operational and administrative support for Latigo-sponsored trials. This role supports start-up, maintenance, and close-out activities, including eTMF set-up, document tracking, meeting coordination, and site and vendor communications.

The candidate will work with clinical trial leads and cross-functional teams to ensure adherence to study plans, ICH-GCP, CFRs, and regulatory requirements.