Regulatory Assistant

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.

We are actively expanding our central teams to support our Principal Investigators (PIs) and research study teams who are focused on our mission-critical trials programs.

The Regulatory Assistant supports regulatory compliance measures and clinical trials by assisting with regulatory submissions, regulatory management, quality control, and the resolution of compliance issues as a member of the Central Regulatory team in Clinical Research Support.

This position will support our GUMO, Gyn Onc and Neuro Onc teams and will be primarily a remote position.

Responsibilities

The Regulatory Assistant demonstrates initiative and sound judgment in problem solving and will be primarily focused on ensuring all regulatory and training documentation is signed, managed, and filed. May have significant interaction with faculty, other team members, internal departments, and external organizations and agencies.

Responsibilities include:

• Assist with preparation and submission of regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional, and federal regulations.
• Maintain study regulatory binders and files within electronic and/or paper binders by ensuring consistent filing of documents for ease of access within binders.
• Manage and maintain protocol training documents.
• Support Principal Investigators (PIs) and Regulatory Coordinators by reviewing drafted trial materials (e.g. informed consent forms).
• Assist with study start-up by preparing required regulatory documents for new study applications.
• Assist in preparing and creating materials for monitoring visits; participate in visits as requested.
• Assist with follow-up and issue resolutions related to regulatory concerns identified during monitoring visits.
• Assist with the preparation and submission modifications/amendments and continuing renewals for ongoing study maintenance.
• Report noncompliance and unanticipated problems to IRB of record.
• Support tracking and reporting of key metrics.
• Support central inbox maintenance and response/escalation to inquiries.

Qualifications

MINIMUM QUALIFICATIONS:

• High school diploma or equivalent.

PREFERRED QUALIFICATIONS:

• Associate's or Bachelor's degree
• Ability to adapt and adjust priorities based on changing needs, strong written and verbal communication skills, problem-solving skills, and the ability to review and reconcile data in reports.
• Ability to use discretion and maintain confidentiality.
• Proficiency with MS Office suite.

The hourly pay range for this position is from $25.72 to $36.62 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).