Clinical Trial Associate

Responsibilities

• Support study start-up activities including site feasibility, selection documentation, and site activation deliverables
• Coordinate collection, review, and filing of site regulatory documents such as CVs, medical licenses, and FDA 1572
• Maintain study tracking tools for site activation, enrollment, monitoring visits, and IRB/EC approvals
• Coordinate study communications, meetings, agendas, and distribution of materials to sites, CROs, and vendors
• Manage the electronic Trial Master File (eTMF) including document processing, metadata quality, and periodic QC
• Partner with CROs and vendors to ensure timely exchange and filing of essential study documents
• Collaborate cross-functionally with Regulatory, Clinical Supplies, Data Management, Safety, and Quality teams

Requirements

• B.S. in Life Sciences, Nursing, or a related field
• Minimum of 2 years of biotech or pharmaceutical industry clinical research experience
• Working knowledge of ICH-GCP and relevant regulatory requirements
• Hands-on experience managing trial documentation and TMF/eTMF processes
• Experience working with CROs, vendors, and investigative sites
• Proficiency with Microsoft Office

Preferred Qualifications

• Oncology clinical trial experience
• Experience supporting audits and inspections
• Familiarity with Veeva Vault eTMF or CTMS
• Experience with site regulatory document collection and IRB/EC submission support
• Proficiency in Smartsheet

About the Company

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies, including antibody-drug conjugates.