Startup Regulatory Coordinator

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 Startup Regulatory Coordinator will provide and manage support for comprehensive startup in the Cancer Consortium. The incumbent will work closely with CRS managers, startup team members, internal and external study teams, central offices, clinic partners, faculty members and research collaborators to ensure regulatory requirements are met.

The Startup Regulatory Coordinator will be a resource to CRS Startup Team members relative to central startup standard practices, generation and submission of regulatory documents and consents in support of larger CRS strategic goals initiatives.

The Startup Regulatory Coordinator will be responsible for expeditious coordination of the regulatory submissions in the study startup phase to support key metrics reported to institutional leadership. This position requires specific understanding of the research process for industry-sponsored clinical trials, advanced institutional knowledge of startup requirements, and dependencies, site specific clinic implementation processes and requirements, regulatory requirements, financial requirements and resources required to conduct clinical research.

JOB DUTIES:

Manage startup timeline, ensuring that all regulatory requirements are executed in parallel with financial, clinic and contractual milestones accurately and expeditiously. Engage stakeholders throughout the study startup lifecycle to ensure adherence to timeline goals.
• Manage required internal and external submissions including but are not limited to: Institutional Review Board (central or local), Institutional Biosafety Committee(s), Human Subjects Division, Institutional Review Office, Radiation Safety Committee, Scientific Review Committee, etc.
• Create informed consent forms in accordance with GCP and FDA guidelines, ensuring all appropriate elements of informed consent; explain complicated research protocol requirements to research participants using easily understood language
• Integrate information from multiple sources and use specialized knowledge of institutional, state, and federal requirements to ensure compliance with those entities.
• Ensure regulatory documentation is accurate and compliant by working proactively with central offices, clinic partners, faculty members and research collaborators.
• Create and manage 1572s, financial disclosures, laboratory accreditations, laboratory reference ranges, CVs, medical licensures, delegation of authority logs, and required training documentation on behalf of study teams to ensure continuity with best practices.
• Serve as a subject matter expert in central startup intake, clinical trial regulatory startup operations and resource allocation.
• Collaborate with pharmaceutical sponsors, institutional sponsors, and study teams to integrate and implement regulatory oversight and review.
• Manage source documentation and records practices throughout the startup process for continuity with CRS standards and best practices in support of IRB, FDA and other institutional and federal oversight.
• Support communications and trackers to maximize transparency and efficiency from intake to handoff.
• Report startup progress to Investigators, study teams, internal and external stakeholders to ensure transparency throughout the startup process in support of larger strategic initiatives.
• Support CRS initiatives that will maximize efficiencies in startup and intake.
• Other duties as assigned

SCOPE OF RESPONSIBILITY:

• Serve as a subject matter expert in central startup intake, clinical trial regulatory startup operations and resource allocation.
• Collaborate with pharmaceutical sponsors, institutional sponsors, and study teams to integrate and implement regulatory oversight and review.
• Manage source documentation and records practices throughout the startup process for continuity with CRS standards and best practices in support of IRB, FDA and other institutional and federal oversight.
• Support communications and trackers to maximize transparency and efficiency from intake to handoff.
• Report startup progress to Investigators, study teams, internal and external stakeholders to ensure transparency throughout the startup process in support of larger strategic initiatives.
• Support CRS SSU initiatives that will maximize efficiencies in startup and intake.

MINIMUM QUALIFICATIONS:

• Bachelor's Degree or equivalent years of experience.
• 3 years' experience working in clinical research environment.
• Experience using central and local IRBs.
• FDA, GCP, and NIH requirements relating to research involving human subjects.
• Demonstrated ability to write informed consent documents.
• Demonstrated ability to work as part of an integrated team.
• Demonstrated ability to deliver a high standard of work.
• Ability to interpret and apply local, state, and federal requirements.
• Strong organizational and document management skills.
• Strong and effective verbal and written communication skills.
• Strong analytical and problem-solving skills.
• Excellent time management skills.
• Advanced knowledge of MS Word and Acrobat

PREFERRED QUALIFICATIONS:

• Clinical research related certification.
• Startup experience.
• Ability to balance changing and competing priorities.

The annual base salary range for this position is from $77,976 to $102,211, 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).