Immunome, Inc.·Bothell, Washington
The CTA supports the operational execution of oncology clinical studies, focusing on study start-up, site activation, and trial conduct. Key duties include managing the electronic Trial Master File (eTMF) and coordinating with CROs and vendors to ensure inspection readiness.
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.
Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.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.
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.
B.S. in Life Sciences, Nursing, or a related field. A minimum of 2 years of biotech / pharmaceutical industry; clinical research experience with increasing responsibility required. Oncology clinical trial experience is strongly preferred. 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. Knowledge and Skills Strong understanding of clinical trial documentation standards and the 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 (e.g., 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 $80,842—$102,175 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).
Requires a B.S. in Life Sciences or Nursing and at least 2 years of biotech or pharmaceutical clinical research experience. Strong knowledge of ICH-GCP and experience with TMF processes, preferably within oncology trials, is required.
Market context
In Washington, operations roles often draw interest from candidates with clerical, scheduling, or process-support experience, especially in education and healthcare settings. These positions can be competitive because employers look for reliable organization, clear communication, and, in this case, current University of Washington enrollment with the required credit load plus at least 6 months of clerical work experience. Review the AI-summarized requirements and benefits on this platform to save time, then confirm your enrollment status and clerical experience before applying.