Clinical Trial Associate – Early Phase

Jobtailor; Thousand Oaks (CA); On-site; USD 60,000 - 90,000; Full time

Job summary

Jobtailor seeks an organized Clinical Trial Operations Coordinator to support Latigo-sponsored trials in Thousand Oaks, CA. You will manage study start-up, maintenance, and close-out, review eTMF structures, and ensure compliance with ICH-GCP and CFR guidelines.

You will coordinate document review, meeting logistics, and vendor interactions, while tracking milestones and budgets. Strong collaboration across time zones and MS Office proficiency are essential.

Qualifications

• 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 regulatory requirements for clinical trials.
• Experience supporting Trial Master File activities preferred.
• Strong organizational skills and attention to detail.
• 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.
• Ability to follow established processes, elevate issues, and support timely resolution of actions.
• Effective collaboration across time zones with internal and external stakeholders.

Responsibilities

• Provide operational and administrative support for Latigo-sponsored clinical trials.
• Support study start-up, maintenance, and close-out activities.
• Review eTMF index and structure and support eTMF setup.
• Collect and track essential documents, site contact information, regulatory documents, and training documentation.
• Oversee electronic Trial Master File maintenance and perform interim quality checks.
• Organize and maintain internal study SharePoint sites.
• 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 system issue follow-up.
• Review and reconcile 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.
• Track clinical trial milestones, deliverables, risks, issues, and decisions; elevate 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 clinical research regulations, ICH-GCP guidelines, study protocols, SOPs, and project-specific plans.
• Perform other clinical operations duties as assigned.

Skills

Clinical Trial Ops

ICH-GCP Compliance

Trial Master File

MS Office Proficiency

Organizational Skills

Education

Bachelor’s degree in science

Tools

SharePoint

eTMF

Clinical Trial Systems

MS Teams

MS Outlook

Job description

• Provide operational and administrative support for Latigo-sponsored clinical trials
• Support study start-up, maintenance, and close-out activities
• Review eTMF index and structure and support eTMF setup
• Collect and track essential documents, site contact information, regulatory documents, and training documentation
• Oversee electronic Trial Master File maintenance and perform interim quality checks
• Organize and maintain internal study SharePoint sites
• 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 system issue follow-up
• Review and reconcile 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
• Track clinical trial milestones, deliverables, risks, issues, and decisions; elevate 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 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 and attention to detail
• 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
• Ability to follow established processes, identify issues, elevate appropriately, and support timely resolution of action items
• Effective collaboration across time zones with internal and external stakeholders

Core Competencies

Demonstrates expertise in clinical trial operations, including study start-up, maintenance, and close-out activities, while ensuring compliance with ICH-GCP guidelines and regulatory requirements. Proficient in managing documentation, tracking milestones, and facilitating effective communication among study teams and vendors.

Highest-signal resume keywords

• Clinical Trial Operations
• ICH-GCP Compliance
• Trial Master File Management
• Microsoft Office Proficiency
• Organizational Skills

Hard Skills

• Clinical Trial Conduct
• Study Start-Up Activities
• Study Maintenance
• Study Close-Out Activities
• Document Review and Reconciliation
• Quality Checks
• Regulatory Document Management
• Meeting Coordination
• Budget Tracking
• Invoice Tracking

Soft Skills

• Attention to Detail
• Effective Collaboration
• Strong Communication Skills
• Ability to Manage Multiple Priorities
• Problem-Solving

Industry Keywords

• Clinical Research Regulations
• CFR Compliance
• SOPs
• Project-Specific Plans
• Study Protocols

Tools & Technologies

• Electronic Trial Master File
• SharePoint
• Clinical Trial Systems
• Microsoft Teams
• Microsoft Outlook