Greater Chicago Midwest HERC

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington.

With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.

At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems.

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.

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.

Qualifications

MINIMUM QUALIFICATIONS:

• 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).

PREFERRED QUALIFICATIONS:

• 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.

The annual base salary range for this position is from $97,822 to $146,681, and pay offered will be based on experience and qualifications.Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.Fred Hutchinson Cancer Center offers employees a comprehensive benefits package designed to enhance health, well-being, and financial security. Benefits include medical/vision, dental, flexible spending accounts, life, disability, retirement, family life support, employee assistance program, onsite health clinic, tuition reimbursement, paid vacation (12-22 days per year), paid sick leave (12-25 days per year), paid holidays (13 days per year), and paid parental leave (up to 4 weeks).

Additional Information