Location: Seattle, Washington
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 Clinical Research Operations Specialist will facilitate and manage study startup for oncology clinical trials in the Cancer Consortium. The incumbent will be responsible for assessing the operational logistics, financial and implementation requirements and managing startup timelines of new industry-sponsored clinical trials. This position will work closely with internal and external regulatory and fiscal specialists to manage startup tasks including the preparation of industry-sponsored clinical trial budgets and will work closely with study teams, central offices, clinic partners, faculty members and research collaborators to ensure implementation needs are met. This position will facilitate centralized study startup standard practices, budget negotiation and clinic implementation in support of larger CRS strategic goals initiatives. This position requires understanding of project and timeline management, understanding of the research process, operationalizing industry-sponsored clinical trial protocols, and knowledge of financial resources required to conduct clinical research.
- Project manage the study startup timeline and operations (including budget development, negotiations and clinic implementation) in continuity with centralized study startup teams standards and practices in support of larger consortium and department strategic initiatives.
- Review and assess new clinical trial documents to identify operational and resource requirements.
- Identify research costs, develop comprehensive budgets and maximize negotiation of industry sponsored clinical trials that support protocol implementation and institutional requirements (i.e. institutional fees, procedure and administrative costs, study team effort, etc.).
- Prepare, submit, and manage internal financial and clinic implementation processes on behalf of the study team.
- Initiate and facilitate meetings with industry sponsors and study teams (i.e., review of startup timelines goals, dependencies, milestones and comprehensive integration of protocol requirements for study implementation).
- Maintain source documentation, correspondence and startup records throughout the startup process (i.e. from study kickoff to study handoff) in alignment with centralized study startup standard practices.
- Monitor and maintain standard internal trackers, timelines and logs to maximize transparency and efficiency among central startup members.
- Work closely with Startup Operations Manager, CRS Startup Team members, consortium members and study teams to support comprehensive study startup process, goals and deadlines.
- Work proactively with central offices, clinic partners, faculty members and research collaborators to ensure protocol requirements can be met upon study activation.
- Report startup progress to industry sponsors, investigators and study teams weekly to ensure transparency throughout the startup process.
- Bachelor's Degree
- Minimum 2-3 years' experience coordinating industry-sponsored clinical trials, preferably oncology trials
- Preparing and/or reviewing study startup documents
- 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
- Clinical research related certification preferred
- Familiarity with project management tools and techniques
- Strong verbal and written communication skills
- Knowledge of applicable local, state and federal regulations and guidelines
- Basic knowledge of clinical trial budgets
- Knowledge of Outlook, MS Teams, Microsoft Office
**Please submit a cover letter when completing the application for this position**
This position is patient facing and/or requires access to Fred Hutch clinical facilities. As such, full COVID-19 vaccination is required as a condition of employment, without exception. Booster doses are strongly recommended but not required. If declining a booster, completion of the COVID-19 Vaccination Status Form Questionnaire and COVID-19 Booster Declination Training is required. Because of our immunocompromised patient population, there are no medical or religious accommodations available for any employee who is patient facing and/or requires access to Fred Hutch clinical facilities. Only employees whose positions are fully remote, who are not patient facing and/or require no access to clinical facilities, may apply for medical or religious accommodations. As a condition of employment, newly hired employees must provide proof of vaccination before their first day of employment.
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 $65,484 to $96,349 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 our Employee Services Center at [email protected]
or by calling 206-667-4700.