Regulatory Affairs Associate

Cures Start Here. At Fred Hutchinson Cancer Research Center (Fred Hutch), home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first and largest cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.

The Vaccine and Infectious Disease Division (VIDD), one of five scientific divisions at Fred Hutch, addresses the growing need for treatment and prevention strategies for infectious diseases worldwide. VIDD is comprised of three research programs—Biostatistics, Bioinformatics & Epidemiology (BBE), Immunology & Vaccine Development (IVD), and Infectious Disease Sciences (IDS). The IVD Program is a large and diverse program, supporting the research of more than 20 faculty, more than 75 active grants and a research staff of more than 200. This program supports a complex portfolio of clinical trials in infectious diseases including HIV vaccine trials, COVID-19 vaccine trials, and related observational studies. The IVD Program currently has a vacancy for a Regulatory Affairs Associate.

The Regulatory Affairs Associate is responsible for providing support and guidance to investigators on regulatory issues and requirements related to the conduct of clinical trials and use of investigational products. This role ensures proper oversight of clinical trials involving investigational new drugs (INDs). The Regulatory Affairs Associate serves as a liaison for PI(s)/study team and various internal/external regulatory oversight groups. This role is also responsible for coordinating submissions to local regulatory bodies including the Institutional Review Board (IRB) and Institutional Biosafety Committee (IBC) under the supervision of the Regulatory Affairs Manager.

 

Primary responsibilities:

• Provide regulatory support to IVD Principal Investigators (PIs) working in multiple clinical trials units including the Vaccine Trials Unit (VTU), the Prevention Center (PC), the COVID Clinical Ressearch Center (CCRC) and other mobile locations
• Write and prepare regulatory submissions including applications, renewals, amendments, consent forms, safety reports, study updates, etc. in accordance with required timelines
• Prepare and coordinate site registration materials/submissions and assist with communications with sponsors and contract research organizations (CROs)
• Assist in the development of project/study policies and procedures. Administer policies and procedures according to protocol, regulatory, and lab safety policies.
• In partnership with the PI, prepare and track all clinical activity documents including IRB/IBC/site registration approvals, safety reports, deviations, laboratory certifications, staff training & licenses, monitoring notices and reports, inspections & compliance, etc.
• Assist with sponsor monitoring visits remotely and onsite as needed
• Create, maintain, and audit systems for tracking and implementing regulated activities at the clinical locations
• Assure the proper management, retention, and version control of all applicable regulatory documentation including master files and amendments
• Assist in the coordination of project activities to ensure they follow timelines and meet deadlines
• Assist in the development of research materials
• Perform information searches related to studies and projects
• Provide clear and concise professional communication in response to reviewing bodies and regulatory agencies
• Use judgment to interpret and apply federal and local regulations regarding clinical research
• Perform other responsibilities as assigned

Required:

• Bachelor’s degree
• 3-5 years of experience working in regulatory affairs or related field
• Previous experience in clinical trials regulatory operations with an emphasis on IND trials in a pharmaceutical, biotechnology, or academic clinical research setting
• Experience preparing and reviewing regulatory applications, communicating with the regulatory committees, preparing for monitoring visits or audits, and assessing risk in the conduct of clinical research
• Understanding and interpreting Good Clinical Practice and Human Subjects regulations
• Excellent verbal and written communication skills
• Highly organized, exhibit strong attention to detail and be able to manage multiple tasks and deadlines

Preferred:

• Ability to work collaboratively
• Successful candidate should be proficient in Microsoft Office Suite, Adobe, and Clinical Trials Management Systems
• Able to work with minimal supervision and within a team environment
• Regulatory Affairs, IRB Professional or Clinical Research certification

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism in your career or that will be made through work at Fred Hutch is requested of all finalists.

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at hrops@fredhutch.org or by calling 206-667-4700.