Regulatory Affairs Associate

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. These values are grounded in and expressed through the principles of diversity, equity and inclusion. 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. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

The Regulatory Affairs Associate will work with faculty and staff within the IIRC, along with regulatory bodies and other departments at Fred Hutch to ensure all clinical trials are supported for regulatory and patient enrollment compliance.

Responsibilities

The role combines both regulatory duties and clinical coordination duties to support the protocols in the program. The primary focus will be regulatory compliance by coordinating regulatory submissions and monitoring as well as assisting with the resolution of compliance issues. The incumbent is expected to work independently within a framework of established regulations and guidelines and demonstrate initiative and sound judgment in problem solving and providing regulatory guidance. Clinical research studies in the program include both investigator-initiated and industry-initiated protocols. The incumbent will prepare IRB documents and FDA correspondence, maintain regulatory files, and facilitate regulatory oversight of safety reporting. The role includes some facilitation of the clinical monitoring of studies for compliance. This position requires independent decision making in all aspects of the research study start up process as well as ongoing regulatory study maintenance. This position will be responsible for expeditious coordination of the regulatory submissions in the study start-up phase to meet sponsor and institutional timelines.

Regulatory Affairs Associate may perform some or all of the following responsibilities:

• Independently prepare IRB documents, draft consent form and study documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting. (30%)
• Manage study start-up: prepare and submit all required regulatory documents for new study applications and successfully open new studies from inception to accrual. (25%)
• Maintain study regulatory binders and electronic files in accordance with institutional and sponsor requirements. Assist in the facilitation of routine study monitoring. (15%)
• Direct the clinical team to ensure all facets of each protocol are compliant and fully covered. (15%)
• Report non-compliances and unanticipated problems to the IRB as applicable. (10%)
• Provide administrative support for federal data reporting requirements, queries and required follow-up from the CRS CT.gov office. (5%)

Qualifications

MINIMUM QUALIFICATIONS:

• Bachelor’s degree or equivalent combination of education and experience. 
• Minimum 2 years of regulatory/IRB related experience in a clinical research environment, relating to:
  • Preparing and reviewing Human Subjects Research applications, and Non-Human Subject Determinations and IRB exemptions.
  • Communications with the IRB, and communications with FDA occasionally and preparing for FDA inspections.
  • Assessing risk in the conduct of clinical research.
  • Designing tools for the regulatory management of clinical trials.
  • Interpreting federal regulations and guidelines.
  • Working with all levels of a research team.
  • Familiarity with process improvement principles.
  • Knowle