Clinical Trial Associate (Late Phase)

Location: Thousand Oaks, California or San Francisco, California; hybrid or office-based expectations. Occasional travel may be required for study team meetings, vendor meetings, site visits, and other clinical trial activities.

Company

hirify.global develops biotherapeutic medicines and conducts company-sponsored clinical trials.

What you will do

• Support clinical trial start-up, maintenance, and close-out activities, including essential document collection and tracking.
• Maintain electronic Trial Master Files, review filing quality, perform interim checks, and support final eTMF transfer.
• Maintain study trackers, contact lists, training records, vendor trackers, and study management tools.
• Coordinate study meetings, investigator meetings, site training, vendor meetings, agendas, minutes, and action items.
• Support clinical trial systems, portals, document uploads, access requests, and issue follow-up.
• Track milestones, deliverables, risks, issues, invoices, budgets, contracts, and work orders, escalating delays as needed.

Requirements

• Bachelor’s degree or equivalent, preferably in a scientific discipline or health-related field.
• At least 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 applicable clinical research regulations.
• Strong organizational, communication, collaboration, and prioritization skills.
• Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and Teams.

Nice to have

• Experience supporting Trial Master File activities.

Culture & Benefits

• Work in a cross-functional clinical operations environment with internal teams, vendors, and trial sites.
• Collaborate across time zones with internal and external stakeholders.
• Participate in occasional travel for clinical trial activities.