Position OverviewImmunome 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.
ResponsibilitiesStudy 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- 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
