Regulatory Affairs Associate, Lead

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 Clinical Research Regulatory Affairs Associate, Lead is responsible for preparing and managing documentation for investigator-initiated clinical trials. The position will review IRB documents, prepare FDA correspondence, maintain regulatory files, and facilitate regulatory oversight of safety reporting. Supports ongoing trials and study initiation for the Clinical Research Support (CRS) Institution-Sponsored IND team.

At Fred Hutchinson Cancer Center, all employees are expected to demonstrate a commitment to our values of collaboration, compassion, determination, excellence, innovation, integrity, and respect.

Cover letters are required from all applicants in order to be considered.

This role will have the opportunity to work partially at our campus and remotely.

Prepares and submits FDA correspondence including IND/IDE applications, relevant study documents, annual reports, and modifications.
• Prepares and submits routine FDA correspondence for investigator-initiated trials.
• Liaises with Investigators and Consortium study teams to ensure accuracy of documentation.
• Maintains regulatory files including IND, Manufacturing, and Trial Master Files (Sponsor).
• Collaborate with data teams to extract data from study databases for scheduled and ad hoc reports for ongoing review of subject accrual data, safety data, and IND annual reports.
• Ensure sponsor oversight and reporting.
• Coordinates monitoring and auditing visits with Clinical Research Support (CRS), industry sponsors, and third-party auditors.
• Other duties as assigned.

MINIMUM QUALIFICATIONS:

• Bachelor's degree in a related field or equivalent combination of education and experience.
• 3 years of clinical research regulatory coordinator experience.
• Knowledge of FDA, ICH/GCP guidelines.
• Experience reviewing IRB documentation and research protocols.
• Experience writing technical documents.
• Strong verbal and written communication skills.
• Excellent time management skills.
• Advanced knowledge of MS Word and Excel.

PREFERRED QUALIFICATIONS:

• Master's degree in regulatory affairs.
• Clinical research related certification.

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

The annual base salary range for this position is from $78,894 to $118,310, and pay offered will be based on experience and qualifications.

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), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).