Clinical Trials Regulatory Coordinator II

Direct Jobs; Seattle (WA); Hybrid; USD 80,172 - 104,250; Full time

Job summary

Fred Hutchinson Cancer Center in Seattle, WA, seeks a Regulatory Coordinator II to support the Infectious Disease Sciences Program on regulatory issues for clinical trials and human subjects research. You will prepare, submit and track IRB, FDA and sponsor documents and coordinate with the IRO and study teams.

This role offers partial campus and remote work, requires at least two years of regulatory experience, knowledge of FDA/GCP, MS Office, and strong communication.

Qualifications

• Two years of regulatory, human research protection or related experience.
• Knowledge of FDA, GCP and NIH requirements and guidelines.
• Ability to interpret and synthesize regulations and adapt to changing priorities.
• Strong written and verbal communication with ability to maintain confidentiality.

Responsibilities

• Prepare, track and maintain regulatory documentation for IRB, FDA, sponsors and other committees.
• Submit regulatory documents to IRB and governing bodies to ensure compliance with GCP and regulations.
• Maintain study regulatory binders and electronic files (SharePoint, Florence, OneDrive, OnCore).
• Lead study start-up: prepare and submit documents for new studies from inception to accrual.
• Prepare and present materials for monitoring visits and coordinate follow-up of regulatory issues.

Skills

Regulatory knowledge

Communication skills

Problem solving

Confidentiality

MS Office proficiency

Education

High school diploma or equivalent

Associate or Bachelor's degree preferred

Tools

IRB/Regulatory platforms

Clinical trial management platforms

Job description

Fred Hutchinson Cancer Center in Seattle, WA, seeks a Regulatory Coordinator II to support the Infectious Disease Sciences Program on regulatory issues for clinical trials and human subjects research. You will prepare, submit and track IRB, FDA and sponsor documents and coordinate with the IRO and study teams.

This role offers partial campus and remote work, requires at least two years of regulatory experience, knowledge of FDA/GCP, MS Office, and strong communication.