Senior In-House Clinical Research Associate

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

SeniorIn-House Clinical Research Associate

Bothell, Washington, United States

Company Overview

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 accepted by the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-1617, a clinical-stage solid tumor ADC; and IM-3050, a clinical-stage FAP-targeted radioligand therapy. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.

Position Overview

The SeniorIn-house Clinical Research Associate (Sr. IHCRA) provides hands-on support for the day-to-day execution of clinical trial activities as assigned by Clinical Project Delivery (CPD) and/or Clinical Site and Trial Operations (CSTO).They operate in compliance with protocols, ICH-GCP, and applicable regulation, and Standard Operating Procedures (SOPs).

This role supports functional activities across assigned trials, sites, and vendors throughout the trial lifecycle, under the guidance and oversight of CPD and CSTO to help ensuretimely, compliant trial execution.

The person in this position mayparticipatein cross-trial process improvement initiatives and may also provide guidance to new or more junior team members.

Responsibilities

Project Delivery and Trial Execution Support

• Assist with completion of assigned project delivery and clinical trial operational tasks in compliance with ICH-GCP, applicable 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.

Site Management and Monitoring Support

• Support site management and monitoring activities as assigned, including tasks related to site selection and activation, investigational product (IP) and clinical supplies management, site monitoring visit preparation, site-level Informed Consent review, and site contracts management.
• Help develop, distribute, review, track, and file essential documents and study binder documents, troubleshooting related issues to ensure on time delivery at all stages.
• Maintain site- and participant-level tracking.
• Support data cleaning activities as assigned
• Assist with day-to-vendor management activities including tracking and workflow management of vendor contracts.
• Support change order and change notification tracking, as assigned.
• May serve as day-to-day vendor contact for assigned activities.
• Participate in vendor teleconferences, record meeting minutes, track action items and decisions.
• Assist with invoice review and budget tracking.

Cross-Functional Collaboration

• Collaborate with the clinical study team members as assigned to support consistency and efficiency of trial execution.
• Develop and maintain positive, effective, and collaborative working relationships with team members and vendors.
• Help onboard and guide new or junior team members.

Qualifications

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

Knowledge and Skills

• Working knowledge of clinical trial processes, and ICH-GCP.
• Strong organizational skills with the ability to manage multiple competing tasks.
• Ability to effectively work cross-functionally and build relationships with stakeholders without direct authority.
• Strong communicationand interpersonal skills.
• Detail-oriented with an analytical approach to problem-solving.
• Able to prioritize and manage multiple tasks and projects in a fast-paced, dynamic environment.
• Highly professional, adaptable, and accountable.

Washington State Pay Range

$127,890 - $155,682 USD

E/E/O

Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.