Regulatory Assistant
Fred Hutchinson Cancer Center is an independent, nonprofit organization focused on cancer treatment and research. The Regulatory Assistant will support regulatory compliance measures and clinical trials by assisting with regulatory submissions, quality control, and compliance issue resolution as part of the Central Regulatory team in Clinical Research Support.
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
Skills
- High school diploma or equivalent
- Associate's or Bachelor's degree
- 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
Benefits
- 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)
Company Overview