Clinical Research Monitor II

Fred Hutchinson Cancer Center•Seattle, WA

1d•Hybrid

About The Position

The Clinical Research Monitor II supports the quality and regulatory compliance of investigator‑initiated oncology clinical trials conducted within the Cancer Consortium. This role performs remote monitoring activities on behalf of the institution to ensure research is conducted in accordance with protocol requirements, Good Clinical Practice (GCP), institutional policies, and applicable regulatory requirements. The Clinical Research Monitor partners closely with investigators, research coordinators, data managers, and regulatory staff to promote data integrity, participant safety, and continuous quality improvement across the clinical research portfolio. This role reports to the Assistant Director of Clinical Research Monitoring within Clinical Research Support (CRS). Most Fred Hutch jobs require some on-campus work. However, there may be flexibility for certain positions. Please check with the recruiter if you are an out-of-state applicant interested only in working outside of the Seattle area.

Requirements

Bachelor's or advanced degree.
Strong knowledge of clinical research with exceptional written, verbal, and interpersonal skills.
Minimum of 7+ years of experience in clinical research monitoring (oncology experience preferred).

Nice To Haves

In-depth knowledge of FDA regulations, GCP guidelines, and other relevant regulatory requirements governing clinical trials.
Experience with electronic data capture (EDC) systems and electronic regulatory platforms.
Effectively partners with cross‑functional teams and external stakeholders to support study goals.
Excellent organizational, analytical, and problem-solving abilities.
Clinical research-related certification.
Experience working in an NCI-designated cancer center or academic consortium environment.

Responsibilities

Independently conduct routine and for‑cause monitoring of oncology clinical trials.
Manage several priorities within multiple complex trials.
Document monitoring observations, prepare written reports, and oversee issues through resolution.
Apply seasoned judgment to identify compliance risks and trends; escalate concerns as appropriate.
Work collaboratively with Principal Investigators and study teams to resolve findings and improve study conduct, including supporting the development of corrective and preventive actions (CAPAs).
Contribute to the development, refinement, and maintenance of standard operating procedures (SOPs), tools, and templates.
Participate in institutional research quality initiatives and process improvement efforts.
Support onboarding, mentoring, and co-monitoring by modeling best practices and reinforcing quality expectations.
Other duties as assigned.