Senior In-House Clinical Research Lead

Immunome, Inc.; Bothell (WA); On-site; USD 128,000 - 156,000; Full time

Job summary

Immunome, Inc. in Bothell, WA is seeking a Senior In-house Clinical Research Associate to support day-to-day trial execution.

You will ensure adherence to ICH-GCP, SOPs, and protocol requirements across assigned trials, sites, and vendors, under CPD/CSTO guidance. Responsibilities include maintaining study timelines, supporting data review and TMF integrity, coordinating site activation, IP and supply management, and aiding in vendor communications.

Qualifications

• Bachelor's degree with 3 years of clinical project or trial management experience in biotechnology or pharmaceutical industry.
• Demonstrated experience with site management and vendor management activities, including CROs and central labs.
• Demonstrated experience with trial documentation and Trial Master File management.

Responsibilities

• Assist with completion of assigned project delivery and clinical trial operational tasks in compliance with ICH-GCP, SOPs, and protocols.
• Help implement various study tracking tools and contribute to the development of study-level documents.
• Maintain study timelines as assigned.
• Assist with data review, protocol deviation review, and the query process as assigned
• Contribute to the development, maintenance and quality control of trial documentation, including study manuals, plans, protocols, instructions, trackers, worksheets, and presentations.
• Help ensure completeness, maintenance, and quality of the Trial Master File.
• Support site management and monitoring activities as assigned, including site activation and IP management.
• Help develop, distribute, review, track, and file essential documents and study binder documents.

Skills

Site management

Vendor management

Trial documentation

Education

Bachelor's degree

Job description

Immunome, Inc. in Bothell, WA is seeking a Senior In-house Clinical Research Associate to support day-to-day trial execution.

You will ensure adherence to ICH-GCP, SOPs, and protocol requirements across assigned trials, sites, and vendors, under CPD/CSTO guidance. Responsibilities include maintaining study timelines, supporting data review and TMF integrity, coordinating site activation, IP and supply management, and aiding in vendor communications.