Senior Clinical Trial Associate

Company Overview Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugate therapies. Our pipeline includes varegacestat, a late-clinical stage GSI; IM-1021, a clinical-stage ROR1 ADC; and IM-3050, a FAP-targeted radiotherapy that recently received IND clearance. We are also advancing a broad portfolio of early stage ADCs pursuing undisclosed solid tumor targets. Position Overview Immunome is seeking a Senior Clinical Trial Associate (Sr. CTA) to support the operational execution of clinical studies across our oncology portfolio. This role partners with Clinical Operation Managers and cross-functional study teams to coordinate study start-up, trial conduct, and closeout activities while ensuring inspection-ready documentation and compliance with ICH-GCP and internal SOPs. The successful candidate is highly organized, detail-oriented, and proactive, with the ability to manage multiple priorities in a fast-paced biotech environment. The level (CTA vs. Sr. CTA) will be determined based on experience and demonstrated independence in clinical operations responsibilities. Occasional travel may be required. Responsibilities Study Start-Up and Site Activation * Support study start-up activities including site feasibility, site selection documentation, and site activation deliverables (regulatory packets, essential documents, training records). * Coordinate collection, review, and filing of site regulatory documents (e.g., CVs, medical licenses, FDA 1572/financial disclosures, delegation logs) in alignment with study requirements. * Track site start-up progress, action items, and timelines; escalate risks or delays to the Clinical Operations Manager as appropriate. Trial Execution and Site Management Support * Maintain study tracking tools for key operational activities (e.g., site activation, enrollment, monitoring visit status, IRB/EC approvals, safety letter distribution). * Coordinate study communications and meetings, including agendas, minutes, follow-up actions, and distribution of study materials to sites, CROs, and vendors. * Support site maintenance and closeout activities, including collection of outstanding documents, reconciliation of logs, and facilitation of site/vendor queries. * Participate in the data cleaning activities as directed by Clinical Operations Manager. Vendor and System Coordination * Partner with CROs and vendors to ensure timely exchange and filing of essential study documents; support access, permissions, and troubleshooting for study systems as needed. * Maintain accurate study information in clinical systems (e.g., eTMF, CTMS, eISF portals) by ensuring timely updates, quality checks, and completeness. * Participate in the system UAT, as needed. Documentation, TMF Quality, and Inspection Readiness * Manage the electronic Trial Master File (eTMF) for assigned studies, including document processing, metadata quality, periodic QC, and completeness checks. * Support development, review, and distribution of study documents such as study plans, trackers, templates, and site communication packages. * Assist with audit/inspection readiness activities including TMF remediation, file reconciliation, and preparation of study documentation for internal or external reviews. Collaboration and Continuous Improvement * Collaborate cross-functionally with Regulatory, Clinical Supplies, Data Management, Safety, and Quality to align on timelines and operational deliverables. * Ensure day-to-day activities follow Immunome SOPs, GCP, and applicable regulations; identify and communicate compliance risks and propose mitigations. * Contribute to process improvements by helping develop or refine trackers, templates, and SOPs, and by sharing best practices across study teams. Qualifications * Bachelor's in Life Sciences, Nursing, or a related field (or equivalent combination of education and experience). * A minimum of 2-3+ years of biotech/pharmaceutical industry Clinical Research experience with increasing responsibility. * Working knowledge of ICH-GCP and relevant regulatory requirements; experience supporting audits/inspections is a plus. * Hands-on experience managing trial documentation and TMF/eTMF processes; familiarity with common systems (e.g., Veeva Vault eTMF/CTMS or similar) preferred. * Experience supporting study start-up, including site regulatory document collection and IRB/EC submission support, is strongly preferred. * Experience working with CROs, vendors, and investigative sites; ability to coordinate deliverables across multiple stakeholders. * Oncology clinical trial experience and/or experience in a biotech environment is strongly preferred. Knowledge and Skills * Strong understanding of clinical trial documentation standards and the purpose/structure of the Trial Master File (TMF). * Excellent organizational skills and attention to detail; able to maintain accurate trackers and manage competing deadlines. * Ability to communicate effectively with internal teams and external partners (sites, CROs, vendors) in a professional, service-oriented manner. * Proficiency with Microsoft Office (Word, Excel, PowerPoint) and comfort learning new clinical systems and processes. Proficiency in Smartsheet is preferred. * Demonstrated ability to proactively identify issues, follow through on action items, and escalate appropriately. * Ability to work independently while also thriving in highly collaborative, cross-functional teams. * Strong problem-solving skills and a continuous-improvement mindset in a dynamic, fast-paced environment. * Commitment to quality and compliance, with a strong sense of ownership for maintaining inspection-ready documentation. Washington State Pay Range $95,000 - $135,000 USD E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. E-Verify Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish). Create a Job Alert Interested in building your career at Immunome, Inc.? 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Created: 2026-04-15