Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutchs pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nations first cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
The Regulatory Coordinator works with faculty and staff in the Infectious Disease Sciences Program in the Vaccine and Infectious Disease Division to ensure all regulatory compliance measures are followed for clinical trials by coordinating regulatory submissions and monitoring as well as assisting with the resolution of compliance issues.
The Regulatory Coordinator works on the Infectious Disease Sciences Programs IRB and Regulatory team reporting to the team manager/supervisor. The position is expected to work independently within a framework of established regulations and guidelines, and demonstrate initiative and sound judgment in problem solving, providing regulatory guidance and developing policies and procedures. This position has significant interactions with the PI(s), other team members, internal departments and external organizations and agencies.
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 g. SharePoint, OneDrive, OnCore.
Perform internal audit and quality assurance checks on regulatory documents.
With input from PIs, study team, draft initial clinical research informed consent forms and study documents.
Lead study start-up; prepare and submit all required regulatory documents for new study applications; successfully open new studies from inception to accrual.
Prepare and present materials for monitoring visits; may 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.
Process IND external safety reports, maintain documentation of PI review and submit safety reports to the IRB as appropriate.
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.
Serve as liaison for internal regulatory bodies (IRB, Clinical Research Support, Regulatory Affairs, etc.)
Stay abreast of new impacts/areas of knowledge and regulatory changes and disseminate this knowledge to the study/operations team. Work with IRB team and IDS leadership to develop standard operating procedures (SOPs).
Identify, develop and implement any necessary revisions to related policies and procedures.
Work with fiscal team/PI/study team regarding funding proposals, annual progress reports.
Coordinate and manage the regulatory documents from each participating sites for studies where IDS serves as the IRB of record (coordinating center). Also track sites annual continuing reviews and alert sites to upcoming expirations to prevent lapses from occurring.
Associates or Bachelors degree and a minimum two years of regulatory, human research protection or related experience in a research environment.
Demonstrated knowledge of regulatory guidelines (IB, 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.
Certified IRB Professional (CIP) certification
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At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.