Regulatory Coordinator II — Hybrid (Remote-Friendly)

Fred Hutchinson Cancer Research Center; Seattle (WA); Hybrid; USD 80,172 - 104,250; Full time

Benefits offered by this job

Tuition reimbursement

Paid vacation and holidays

Health benefits

Onsite health clinic

Job summary

Fred Hutchinson Cancer Center in Seattle is seeking a Regulatory Coordinator II to support investigators within the Infectious Disease Sciences Program on regulatory issues for clinical trials and human subjects research. The role involves coordinating IRB submissions, maintaining regulatory binders, and serving as the primary contact during monitoring visits, with partial on-site and remote work options.

A minimum two years of regulatory experience is required, with preferred associates or

Qualifications

• High school diploma or equivalent.
• Demonstrated knowledge of regulatory guidelines (IRB, IACUC, MUA, etc.).
• Knowledge of FDA, GCP and NIH requirements.
• Ability to interpret and synthesize regulations and guidelines.
• Ability to adapt and adjust priorities based on changing needs, strong written and verbal communication skills, problem solving skills and the ability to reach and reconcile data in reports.
• Ability to use discretion and maintain confidentiality.

Responsibilities

• Prepare, track and maintain all correspondence and regulatory documentation required by the IRB, FDA, sponsors, and other committees.
• Submit regulatory documents to IRB and governing bodies to maintain study compliance with GCP and regulations.
• Maintain study regulatory binders and electronic files (e.g., SharePoint, Florence, OneDrive, OnCore).
• Perform internal audit and quality assurance checks on regulatory documents.
• Lead study start-up: prepare and submit regulatory documents for new studies from inception to accrual.
• Prepare and present materials for monitoring visits and serve as primary contact during visits.
• Prepare and submit modifications/amendments and continuing renewals for ongoing studies.
• Conduct study close-out and archive regulatory records for off-site storage.
• Report non-compliance and unanticipated problems to the IRB as applicable.
• Serve as primary regulatory resource for PIs and sponsors regarding approvals and patient consent.
• Coordinate with fiscal team on funding proposals and annual progress reports.
• Coordinate regulatory documents from participating sites where IDS serves as IRB of record.
• Perform other tasks as assigned.

Skills

Regulatory guidelines knowledge

FDA/NIH/GCP knowledge

Regulatory documentation

Written and verbal communication

Discretion and confidentiality

Education

High school diploma

Associate or Bachelor’s degree preferred

Tools

SharePoint

OnCore

OneDrive

Florence

Job description

Fred Hutchinson Cancer Center in Seattle is seeking a Regulatory Coordinator II to support investigators within the Infectious Disease Sciences Program on regulatory issues for clinical trials and human subjects research. The role involves coordinating IRB submissions, maintaining regulatory binders, and serving as the primary contact during monitoring visits, with partial on-site and remote work options.

A minimum two years of regulatory experience is required, with preferred associates or