United States onlyOverview
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 Assistant is part of our central team providing regulatory support to Principal Investigators (PIs) and research study teams focused on mission-critical clinical trials programs. The role will be responsible for regulatory management of trials, which may cover submissions in the study startup phase through closeout. The incumbent will report to the Assistant Director of Regulatory Operations.
This is a remote position
Responsibilities
- 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.
- 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.
PREFERRED QUALIFICATIONS
- Associate’s or Bachelor’s degree
- Preferred experience with research in a work or academic setting
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 hourly pay range for this position is from $24.48 to $34.86 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).
