Regulatory Coordinator II

Fred Hutchinson Cancer Center•Seattle, WA

5d•Hybrid

About The Position

Fred Hutchinson Cancer Center is an independent, nonprofit organization providing adult cancer treatment and groundbreaking research focused on cancer and infectious diseases. Based in Seattle, Fred Hutch is the only National Cancer Institute-designated cancer center in Washington. With a track record of global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy and COVID-19 vaccines, Fred Hutch has earned a reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality. At Fred Hutch we value collaboration, compassion, determination, excellence, innovation, integrity and respect. Our mission is directly tied to the humanity, dignity and inherent value of each employee, patient, community member and supporter. Our commitment to learning across our differences and similarities make us stronger. We seek employees who bring different and innovative ways of seeing the world and solving problems. 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.

Requirements

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.

Nice To Haves

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.

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.