Clinical Trials Regulatory Coordinator II

Fred Hutch; Seattle (WA); Hybrid; USD 80,172 - 104,250; Full time

Job summary

Fred Hutchinson Cancer Center in Seattle seeks a Regulatory Coordinator II to support the Infectious Disease Sciences Program with regulatory submissions and documentation for clinical trials. This role works with IRB, FDA and sponsors, coordinating start-up activities and ongoing compliance across sites.

The position requires 2+ years in regulatory environments, knowledge of FDA/GCP/NIH guidelines and strong communication. Hybrid work options and a collaborative team culture are offered.

Qualifications

• High school diploma or equivalent.
• Minimum of two years of regulatory, human research protection or related experience in a research environment.
• 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.
• Proficiency with MS Office suite.

Responsibilities

• Prepare, track and maintain all correspondence and regulatory documentation required by the IRB, FDA, sponsors, and other institutional and federal oversight committees, including drafting and reviewing content as appropriate.
• Submit all regulatory documents to the IRB and other governing bodies to maintain study compliance with GCP, institutional and federal regulations.
• Maintain study regulatory binders and electronic files e.g., SharePoint, Florence, OneDrive, OnCore, etc.
• Perform internal audit and quality assurance checks on regulatory documents.
• Lead study start-up: prepare and submit all required regulatory documents for new study applications; open new studies from inception to accrual.
• Prepare and present materials for monitoring visits; serve as primary point of contact during visits. Independently follow-up and resolve all issues related to regulatory concerns identified during monitoring visits.
• Prepare and submit modifications/amendments, and continuing renewals for ongoing study maintenance in a timely manner.
• Conduct study close-out. Be responsible for archiving regulatory documents/records, ensuring that all files are prepared for off-site storage in accordance with FDA, other applicable regulatory guidelines and program SOP.
• Report non-compliance and unanticipated problems to the IRB as applicable.
• Serve as primary regulatory resource for PIs, sponsors, a study team, providing guidance on regulatory statuses, approvals and instructions regarding patient consent.
• Work with fiscal team/PI/study team regarding funding proposals, annual progress reports.
• Coordinate and manage the regulatory documents from each participating site for studies where IDS serves as the IRB of record (coordinating center). Track sites’ annual continuing reviews and alert sites to upcoming expirations to prevent lapses from occurring.
• Perform other tasks as assigned.

Skills

Regulatory guidelines

FDA/GCP/NIH knowledge

MS Office

Communication skills

Prioritization

Education

High school diploma or equivalent

Associate or Bachelor’s degree (preferred)

Tools

MS Office suite

Job description

Fred Hutchinson Cancer Center in Seattle seeks a Regulatory Coordinator II to support the Infectious Disease Sciences Program with regulatory submissions and documentation for clinical trials. This role works with IRB, FDA and sponsors, coordinating start-up activities and ongoing compliance across sites.

The position requires 2+ years in regulatory environments, knowledge of FDA/GCP/NIH guidelines and strong communication. Hybrid work options and a collaborative team culture are offered.