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, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. S.

FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets. Position Overview Immunome is seeking a Clinical Trial Associate (CTA) to support the operational execution of clinical studies across our oncology portfolio.

This role will partner 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. 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).

Requirements

Track site start-up progress, action items, and timelines; escalate risks or delays to the Clinical Operations Manager as appropriate. , 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.

, 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