Clinical Trial Associate – Late Phase

Jobtailor; San Francisco (CA); On-site; USD 70,000 - 95,000; Full time

Job summary

Jobtailor is seeking an organized clinical operations professional to provide operational and administrative support across Latigo-sponsored clinical trials. You will assist study start-up, maintenance, and close-out, review eTMF index, and manage regulatory documents and training records.

This role requires strong communication, attention to detail, and experience with Microsoft Office and SharePoint. You’ll collaborate across study teams and vendors to keep trials on track and compliant with

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 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
• Demonstrated ability to follow established processes, identify issues, elevate appropriately, and support timely resolution of action items
• Effective collaboration across time zones and with internal and external stakeholders

Responsibilities

• Provide operational and administrative support for Latigo-sponsored clinical trials
• Support clinical operations across study start-up, maintenance, and close-out activities
• Review eTMF index/structure and perform eTMF set-up activities
• Collect and track essential documents, site contact information, regulatory documents, and training documentation
• Oversee maintenance of the electronic Trial Master File 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
• Support clinical trial systems and portals, including access requests, user tracking, document uploads, and 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; escalated delays or issues
• Support backroom operations during regulatory inspections
• Track invoices, budgets, contracts, and work orders
• Maintain awareness of applicable clinical research regulations, ICH-GCP guidelines, study protocols, SOPs, and project-specific plans
• Perform other clinical operations duties as assigned

Skills

Clinical Trial Operations

ICH-GCP Compliance

Trial Master File Management

Microsoft Office Proficiency

Organizational Skills

Education

Bachelor’s degree or equivalent

Tools

SharePoint

Clinical Trial Systems

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Microsoft Teams

Job description

• Provide operational and administrative support for Latigo-sponsored clinical trials


• Support clinical operations across study start-up, maintenance, and close-out activities


• Review eTMF index/structure and perform eTMF set-up activities


• Collect and track essential documents, site contact information, regulatory documents, and training documentation


• Oversee maintenance of the electronic Trial Master File 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


• Support clinical trial systems and portals, including access requests, user tracking, document uploads, and 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; escalated delays or issues


• Support backroom operations during regulatory inspections


• Track invoices, budgets, contracts, and work orders


• 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 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


• Demonstrated ability to follow established processes, identify issues, elevate appropriately, and support timely resolution of action items


• Effective collaboration across time zones and 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

ATS Optimization Keywords

Hard Skills

• Clinical Trial Conduct


• Study Start-Up Activities


• Study Maintenance


• Study Close-Out Activities


• ETMF Set-Up


• Document Tracking


• Regulatory Document Review


• Quality Checks


• Budget Tracking


• Invoice Management

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


• Study Protocols


• Regulatory Inspections

Tools & Technologies

• SharePoint


• Clinical Trial Systems


• Microsoft Word


• Microsoft Excel


• Microsoft PowerPoint


• Microsoft Outlook


• Microsoft Teams