Senior Clinical Trial Associate

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.