Regulatory Affairs Associate, Senior

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 Senior Regulatory Affairs Associate will work with faculty and staff in the program to ensure all clinical trials are covered for regulatory and patient enrollment compliance, ensure proper regulatory oversight of clinical trials involving investigational new drugs (INDs) and lead a team of Regulatory Affairs Associates and Coordinators.

Responsibilities

The Senior Regulatory Affairs Associate works independently in acting as a liaison for PI(s)/study team and various internal/external regulatory oversight groups for clinical trials involving INDs and in providing internal training related to regulatory policies, procedures, and best practices.

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 coverage 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.

May perform some or all of the following responsibilities:

• Lead Regulatory Affairs Associates and Coordinators in the regulatory management of clinical trial portfolio
• Independently prepare IRB documents, draft consent form and study documents, maintain regulatory files, and facilitate regulatory oversight of safety reporting.
• In concert with IND Sponsors, prepare and review IND submissions, communicate with the FDA, and prepare for FDA audits.
• Lead study start-up: prepare and submit all required regulatory documents for new study applications and successfully open new studies from inception to accrual.
• Maintain study regulatory binders and electronic files in accordance with institutional and sponsor requirements.
• Direct the clinical team to ensure all facets of each protocol are compliant and fully covered.
• Report non-compliances and unanticipated problems to the IRB as applicable.
• Serve as liaison for PI/study team, IND oversight committee, medical monitor and the FDA
• Independently draft FDA correspondence and review correspondence drafted by PI/study team
•  Prepare, ship, maintain and archive all submissions to FDA
•  Develop policies, procedures, templates, etc. associated with IND oversight committee/charter serious adverse event (SAE) reporting requirements (template language for protocols, reporting forms, instructions, etc.)
• Maintain investigator regulatory f