Regulatory Coordinator II/Regulatory Affairs Assc

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. These values are grounded in and expressed through the principles of diversity, equity and inclusion. 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. Fred Hutch is in pursuit of becoming an anti-racist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, anti-racism and inclusion.

The Research Coordinator II/Regulatory Affairs Associate 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 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.

Regulatory Coordinator II 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.
• Process IND external safety reports, maintain documentation of PI review and submit safety reports to the IRB as appropriate.
• Perform other tasks as assigned.

Additional Responsibilities at Regulatory Affairs Associate level:

• Provides proactive regulatory consultation and support throughout the lifecycle of clinical trials and human subjects research projects.
• Participates in and provides regulatory expertise interpretation to IDS investigators, clinical research staff and finance team.
• Stay abreast of new impacts/areas of knowledge and regulatory changes and disseminate this knowledge to the study/operations team. Work with IRB team to develop internal guidelines and standard operating procedures (SOPs) to ensure the IDS Program conducts its regulatory activities in accordance with FDA/ICH regulations.
• Advises IDS investigators, clinical research staff and regulatory support staff on processes, guidelines and best practices related to regulatory affairs.
• Provides representation and direct support to sponsor-investigators, clinical investigators, and staff with FDA communications including support during FDA inspections, as needed.

MINIMUM QUALIFICATIONS:

Research Coordinator II:

• High school diploma or equivalent
• A minimum one year of regulatory, human research protection or related experience in a research environment.
• Previous work experience preparing and/or reviewing study start-up documents, including IRB documentation and research protocols.
• Knowledge of FDA, NIH, ICH/GCP guidelines.
• Strong verbal and written communication skills working across multiple disciplinary teams.
• Ability to adapt and adjust priorities based on changing needs, and the ability to troubleshoot and utilize problem-solving skills.
• Excellent time management skills and meet different deadlines.
• Attention-to-detail is critical.
• Ability to use discretion and maintain confidentiality.
• Working knowledge of Microsoft Suite, SharePoint, Adobe Suite, Clinical Trials Management System(s).
• Ability to use discretion and maintain confidentiality.

Regulatory Affairs Associate:

• Bachelor's degree or equivalent combination of education and experience.
• Minimum 2 years of regulatory/IRB related experience in a clinical research environment, relating to:
  • Preparing and reviewing Human Subjects Research applications, and Non-Human Subject Determinations and IRB exemptions.
  • Communications with the IRB, and communications with FDA occasionally and preparing for FDA inspections.
  • Assessing risk in the conduct of clinical research.
  • Designing tools for the regulatory management of clinical trials.
  • Interpreting federal regulations and guidelines.
  • Working with all levels of a research team.

PREFERRED QUALIFICATIONS:

Research Coordinator II:

• Associate or Bachelor's degree.
• Two or more years of experience in regulatory, human subjects or related experience.
• Certified IRB Professional (CIP) certification.
• Previous clinical research regulatory coordinator experience working within Fred Hutchinson Cancer Center or University of Washington's institutional regulatory system.
• Previous experience working with online/web-based platforms for clinical trial management systems.
• Knowledge of regulations and guidelines that govern clinical research, including but not limited to FDA regulations and Good Clinical Practice

Regulatory Affairs Associate:

• Clinical research related certification.
• Familiarity with process improvement principles
• Knowledge of regulations and guidelines that govern clinical research and human subjects research compliance, including, but not limited to FDA and Good Clinical Practice regulations.
• Prior experience working with E-Binders (e.g., Florence)

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Regulatory Coordinator II: The annual base salary range for this position is from $68,162 to $102,211, and pay offered will be based on experience and qualifications.
Regulatory Affairs Associate: The annual base salary range for this position is from $75,151 to $112,673, and pay offered will be based on experience and qualifications.

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), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).