Senior In-House Clinical Trials Associate

Immunomeinc; Bothell (WA); On-site; USD 128,000 - 156,000; Full time

Job summary

Immunome, Inc. in Washington state seeks a Senior In-house Clinical Research Associate (Sr. IHCRA) to support day-to-day trial execution across sites and vendors, in compliance with ICH-GCP and SOPs.

You will work under CPD/CSTO guidance to help ensure timely, compliant trial delivery. The role requires a Bachelor’s degree with 3 years of clinical project or trial management in biotech or pharma, plus experience with site and vendor management, trial documentation, and cross-functional

Qualifications

• Bachelor’s degree with 3 years of clinical project or trial management experience in biotech 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 study tracking tools and contribute to study-level documents.
• Maintain study timelines as assigned.
• Assist with data review, protocol deviation review, and the query process.
• Contribute to development, maintenance and quality control of trial documents and TMF files.
• Help ensure completeness and quality of the Trial Master File.
• Support site management and monitoring activities including site activation and IP management.
• Develop, distribute, review, track, and file essential documents and study binder documents.
• Maintain site- and participant-level tracking.
• Support data cleaning activities.

Skills

Clinical trial management

Site management

Vendor management

ICH-GCP

Documentation & data integrity

Cross-functional collaboration

Communication skills

Education

Bachelor’s degree with 3 years of clinical project or trial management experience in biotech or pharma

Job description

Immunome, Inc. in Washington state seeks a Senior In-house Clinical Research Associate (Sr. IHCRA) to support day-to-day trial execution across sites and vendors, in compliance with ICH-GCP and SOPs.

You will work under CPD/CSTO guidance to help ensure timely, compliant trial delivery. The role requires a Bachelor’s degree with 3 years of clinical project or trial management in biotech or pharma, plus experience with site and vendor management, trial documentation, and cross-functional