About the Role

You will be the operational backbone of our clinical trials. You'll own the systems, documents, and workflows that keep sites compliant, queries moving, and trial data clean. This means maintaining our Trial Master File, coordinating with CROs and sites, managing documentation across multiple programs, and ensuring every submission to FDA is inspection-ready.

What makes this different: you won't just manage documents. You'll work alongside our clinical AI systems, identify where automation can accelerate workflow, and scale operations without adding headcount. Your attention to detail and knowledge of trial structure will be the foundation that lets Pathos compress timelines and move faster than traditional biotech.

Key Responsibilities:

Trial Operations & Documentation

• Maintain the Trial Master File and electronic Trial Master File across all active oncology programs, ensuring completeness, accuracy, and compliance with ICH-GCP Section 8
• Review site documentation for completeness and accuracy before study initiation and during ongoing monitoring
• Coordinate document distribution to sites, investigators, and regulatory partners
• Track Case Report Forms, data queries, and clinical data flow from submission through resolution

Site & Vendor Coordination

• Serve as the primary point of contact between Pathos and CRO Clinical Research Associates for day-to-day trial communications
• Coordinate with Clinical Trial Supply vendors and manage tracking systems for investigational product distribution
• Liaise with equipment vendors and third-party service providers to resolve operational issues and track resolution
• Prepare and update Investigator and Pharmacy site files before study initiation

Regulatory & Compliance

• Contribute to key study documents including protocols, informed consent forms, case report forms, and clinical study reports
• Understand and implement ICH-GCP, ISO 14155, and applicable local requirements across trials
• Prepare audit and inspection documentation in collaboration with clinical leadership
• Track regulatory commitments and timelines to ensure on-time execution

Systems & Process

• Identify gaps in current clinical workflows and recommend automation or tool improvements
• Maintain organized filing systems (physical and digital) according to standard operating procedures
• Support payment processing for study-related costs and vendor invoices
• Complete all required training on schedule and stay current on regulatory and company-specific requirements

Who You Are

• Undergraduate degree in nursing, life sciences, or medical documentation preferred
• 1 to 2 years of clinical trial experience preferred
• Proficiency with Excel, Word, PowerPoint, etc.. Comfort learning new tools and systems quickly
• Strong organizational skills and attention to detail. You catch errors others miss and prevent problems before they happen
• Ability to work independently and as part of a team. You manage your own workload, hit deadlines, and communicate proactively when something is off track
• Clear written and verbal communication. You explain complex regulatory concepts simply and document decisions so others understand your reasoning
• Working knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. You'll deepen this through company training
• Genuine curiosity about how Pathos's AI systems work and how they apply to clinical operations.

Location
Hybrid, 3 days per week onsite at our NYC headquarters.