Startup Operations Manager – Non Industry Startup
Seattle, WA, United States
Overview
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.
We are actively expanding our central research teams to support Principal Investigators (PIs) and study teams who are focused on mission-critical clinical trials programs.
This position will provide and manage support for centralized clinical trial start-up in Clinical Research Support. The incumbent will be responsible for assessing the operational logistics of new non-industry oncology clinical trials and creating startup plans, review requirements and timelines. Non industry clinical trials include studies sponsored by foundations, federal agencies, and other non-industry funding sources.
This position will manage CRS Non-Industry Startup Team and train Startup Operations & Budget Specialists relative to centralized study startup standard practices, negotiation and clinic implementation in support of larger CRS strategic goals initiatives. This position will work with internal and external regulatory and fiscal specialists, to oversee and manage non-industry startup workflow.
This position will develop and continue to refine best practices for a centralized non-industry study startup model. This position will be a subject matter expert for research processes, non-industry-sponsored oncology clinical trials, and maintain instititutional knowledge of startup requirements, dependencies, site-specific clinic implementation, pre and post-award requirements.
Responsibilities
Prioritize and proactively implement standardization of startup services to support non-industry clinical trials.
Oversee Startup Operations & Budget Specialists & regulatory specialists facilitating centralized non-industry startup activities on behalf of study teams.
Closely partner with protocol writing services for Investigator Initiated Trials (IITs) to help ensure operational and financial feasibility considerations are taken into account during the protocol development process.
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.
Review and assess new clinical trial documents to identify and anticipate operational and resource requirements.
Serve as subject matter expert in identifying research costs, reviewing study calendars & billing grids, developing and negotiating budgets, coordinating contracting processes in accordance w/protocol and institutional requirements.
Manage and oversee the preparation and submissions of new clinical trials to internal financial, regulatory and clinical offices.
Initiate and facilitate meetings with investigators, 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 record keeping practices throughout the startup process; ensure continuity with CRS standards and best practices for optimal transparency.
Oversee and optimize weekly startup progress reporting to Investigators, study teams, internal and external stakeholders 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 non-industry study startup plan, goals and deadlines.
Work professionally and proactively with central offices, clinic partners, faculty members and research collaborators in support of the overall research plan.
Maintain current understanding of non-industry study startup operations, timelines and budgeting trends; 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.
Qualifications
MINIMUM QUALIFICATIONS:
Bachelor's degree and 4 years of experience
Starting and managing oncology clinical trials, startup processes and study budgets
Mentoring/training staff and/or teams
Working across different academic institutions to facilitate research projects
Working with multi-disciplinary teams
Forecasting and meeting deadlines
Communicating with all levels of a research organization
Team building and management
CTMS Knowledge & Experience
Proficiency in use of systems to support workflow & metrics
Strong verbal and written communication skills
Knowledge of applicable local, state and federal regulations and guidelines
Preferred Qualifications
Clinical research related certification
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.
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).
Our Commitment to Diversity
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 [email protected] or by calling 206-667-4700.
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