The Regulatory Coordinator II is responsible for providing support to investigators and staff within the Infectious Disease Sciences (IDS) Program in the Vaccine and Infectious Disease Division on regulatory issues and requirements both prior and during the conduct of clinical trials and human subjects’ research. The incumbent will oversee communications with the industry sponsors, Fred Hutch IRB and provide direct support to study teams and other regulatory staff in IDS in the preparation of regulatory documentation. This position will interact with the Institutional Review Office (IRO) for the Infectious Disease Sciences Program to the division, Center departments and Cancer Consortium. The incumbent will work under the direction of the Senior Project Manager in the IDS Program.

This role will have the opportunity to work partially at our campus and remotely.

Please submit a cover letter explaining your interest in this position when applying to be considered for this role.

• 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.

MINIMUM 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.

PREFERRED QUALIFICATIONS:

• Associate or Bachelor’s degree.
• Previous clinical research regulatory coordinator experience working within Fred Hutchinson Cancer Center, University of Washington, or Seattle Children’s institutional regulatory system.
• Previous experience working with online/web-based platforms for clinical trial management.
• Knowledge of regulations and guidelines that govern clinical research, including but not limited to FDA regulations and Good Clinical Practice.

The annual base salary range for this position is from $80,172 to $104,250, and pay offered will be based on experience and qualifications.Although Fred Hutch is not sponsoring most H-1B visas at this time, candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.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), and paid parental leave (up to 4 weeks).