Crs Industry Startup Regulatory Operations Manager

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.

 

This position will manage Startup Regulatory coordinators and leads on the centralized clinical trial startup team within Clinical Research Support (CRS). The incumbent will be responsible for managing and overseeing startup tasks including the preparation and submission of regulatory documents in the study startup phase to support key metrics reported to institutional leadership. The Regulatory Operations Manager is responsible for understanding, planning and executing regulatory requirements needed to conduct compliant clinical research. This position requires knowledge of timeline dependencies and best practices associated with industry-sponsored oncology clinical trial startup.

The Industry Startup Regulatory Operations Manager will manage regulatory startup team members and facilitate or support operational training in alignment with centralized study startup standard practices, essential regulatory documents, consent form writing, and regulatory submissions in support of larger CRS strategic goals initiatives. This position will also work with internal and external regulatory and fiscal specialists, to oversee and manage Industry Startup workflow.

 

The Industry Startup Regulatory Operations Manager will develop and continue to refine best practices for a centralized industry study startup model. This position will be a subject matter expert for research processes and industry-sponsored oncology clinical trial startup. The incumbent will maintain instititutional knowledge of regulatory startup, workflow dependencies, FDA, GCP, and NIH requirements relating to research involving human subjects.

 

Most Fred Hutch jobs require some on-campus work. However, there may be flexibility for certain positions. Please check with the recruiter if you are an out-of-state applicant interested only in working outside of the Seattle area.

• Prioritize and proactively implement standardization of startup services to support fully centralized Industry Startup services.
• Oversee Regulatory Startup team facilitating centralized startup on behalf of study teams.
• Manage and oversee operations to ensure continuity with central startup metric goals, best practices and standards in support of larger CRS strategic initiatives to reduce startup times.
• Assess new clinical trial documents impacts; identify and anticipate regulatory requirements.
• Serve as a subject matter expert in identifying regulatory requirements and developing informed consents in accordance with institutional, GCP and FDA guidelines.
• Serve as a subject matter expert in preparing internal and external submissions required for site activation including but are not limited to: Institutional Review Board, the Institutional Biosafety Committees, the Radiation Safety Committee, Scientific Review Committee, Human Subjects Division and Institutional Review Office.
• Manage integration of information from multiple sources; maintain specialized knowledge of institutional, state, and federal requirements to ensure compliance with those entities.
• Manage and oversee the preparation and submissions of new clinical trials to internal financial, regulatory and clinical offices.
• Initiate and manage meetings with industry sponsors, study teams and central office partners in support of centralization, timeline reduction, workflow and process improvement goals.
• Provide management and oversight of central team source documentation maintenance and recordskeeping practices throughout the startup process; ensure continuity with CRS standards and best practices for optimal transparency.
• Oversee and optimize weekly startup progress reporting to industry sponsors, Investigators and study teams to ensure transparency and accurate expectations throughout the startup process.
• Work closely with Asst Director of Clinical Trial Startup to ensure process continuity, transparency, and efficiency in support of consortium startup metrics; determine and improve operational process standards based on feedback and data from internal and external partners.
• Work closely with Consortium members and study teams to support comprehensive industry study startup plan, goals and deadlines.
• Work professionally and proactively with central offices, clinic partners, faculty members, funding sponsors, and research collaborators in support of the overall research plan.
• Maintain current understanding of industry study startup operations, timelines, and market trends in clinical research; make recommendations to Asst Director of Clinical Trial Startup.
• Participate in continuing education opportunities to support and advance professional development of project management, clinic trial implementation and budget development skills.
• Participate and facilitate process improvement efforts on behalf of the Consortium including implementation of technology solutions and/or workflow improvements.

 

MINIMUM QUALIFICATIONS:

• Bachelor’s Degree and 4 years experience
• Experience managing oncology clinical trials startup processes
• Understanding and application of local, state, FDA regulations and GCP guidelines
• Mentoring/training staff and team building
• Working across different academic institutions to facilitate research projects
• Working with multi-disciplinary teams
• Managing regulatory startup of industry sponsored clinical trials
• Forecasting and meeting deadlines
• Communicating with all levels of a research organization
• Proficiency in use of CTMS and electronic regulatory binder system
• Proficiency in use of systems to support workflow & metrics
• Proficiency in use of MS Word and Acrobat

PREFERRED QUALIFICATIONS:

• Clinical research related certification preferred
• Strong verbal and written communication skills
• Strong attention to detail and ability to work according to Standard Operating Procedures (SOPs)
• Excellent interpersonal skills and ability to build strong relationships with stakeholders
• Effective communication, troubleshooting, change management and conflict resolution skills within a remote setting.

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.

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The annual base salary range for this position is from $94,702 to $149,656, 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). 

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to Human Resources at hrops@fredhutch.org or by calling 206-667-4700.