Senior Clinical Trial Associate

Immunome, Inc.•Bothell, WA

3d•$95,000 - $135,000

About The Position

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.

Requirements

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.
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.

Nice To Haves

Oncology clinical trial experience and/or experience in a biotech environment is strongly preferred.

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.