Immunome, Inc.

Clinical Trial Associate

Bothell, Washington, United States

Sponsorship not specifiedDetected 14 days ago

GCPExcelClinical TrialsClinical ResearchFDA RegulatoryResearchLeadershipCommunicationCollaborationOrganizational SkillsMicrosoft Office

About the role

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

Support study start-up activities including site feasibility, site selection documentation, and site activation deliverables (regulatory packets, essential documents, training records).
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).
Support site maintenance and closeout activities, including collection of outstanding documents, reconciliation of logs, and facilitation of site/vendor queries.
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.
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.
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.

A minimum of 2 years of biotech / pharmaceutical industry
clinical research experience with increasing responsibility required.
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).
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.
B.S. in Life Sciences, Nursing, or a related field.
Experience supporting study start-up, including site regulatory document collection and IRB / EC submission support is strongly preferred.
Excellent organizational skills and attention to detail

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.
Proficiency in Smartsheet is preferred.

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.

This listing is sourced directly from Immunome, Inc.'s careers page and normalized into a canonical job model.