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.

The Clinical Research Operations Manager (CROM) will manage the Clinical Research Program for chronic lymphocytic leukemia (CLL), and multiple myeloma. This active program encompasses translational research protocols, interventional clinical protocols and involves supervision of a talented team of 12 Research Staff. The incumbent works under the direct supervision of the Principal Investigators (PIs) to address research questions proactively and independently in cooperation with internal and external stakeholders within the scope of applicable federal, state, and institutional guidelines.

Responsibilities

In collaboration with the PIs, the CROM will manage program operations, including full lifecycle management of clinical studies, ensuring oversight from study start-up to project completion; balance study staff workloads; oversight of regulatory issues and development of process improvement for trial conduct and compliance. The incumbent will interact with patients, caregivers, physicians, laboratory researchers and other clinical providers and support staff within and outside of the Cancer Consortium, and will be expected to create, foster, and maintain cross-functional working relationships with internal teams and external partners.

Program Management:

• Maintain up to date working knowledge of all research studies and projects within the portfolio.
• Lead a clinical research team of data, regulatory, and clinical research coordinators. Assign and adjust workloads according to program needs.
• Perform all Personnel Management & Human Resources activities for direct reports: hiring, evaluating performance, and onboarding/offboarding.
• Provide opportunities for initial and ongoing training, mentorship, and professional development, ensuring all study staff are properly trained and supervised within their role.
• Identify and resolve operational issues; develop, implement, and maintain program policies, procedures, and systems to ensure safety, compliance, quality, and maximum efficiency.
• Represent the program on institutional committees and working groups, participate in consortium and division research meetings, regularly attend research and clinical meetings with PIs, and join study-specific meetings as needed.
• Partner with PIs to manage translational research projects, such as specimen repositories, retrospective chart reviews, disease-specific data reviews and requests, and serve on institutional committees to represent Fred Hutch clinical research interests.
• May perform other duties in support of overall program goals as assigned by PIs.

Protocol Implementation & Study Conduct:

• Complete feasibility questionnaires for new trials, arrange for and conduct site qualification visits, coordinate with clinical teams on early feasibility.
• Lead and manage the study Start-Up and amendment processes, including protocol intake and assessment, CTMS submission, review of billing grid/coverage analysis, orders, and fact sheets, and communication with internal stakeholders and study sponsors/CROs.
• Identify implementation and operational study challenges and resolve in collaboration with study team, PIs, and study sponsors.
• Facilitate interactions between the study team and clinical sites of practice, to include interacting with a variety of internal and external departments. Collaborate with and maintain ongoing communication with all research partners.
• Assist in the development of data acquisition forms and databases for investigator-initiated studies, partnering with data collection resources, as applicable.
• Collaborate with Financial Manager to support contract and budget negotiations and amendments to existing contracts, as needed. Make recommendations for study budget in accordance with protocol requirements.
• When required, partner with internal and outside laboratories for sample collection, transport, processing, and storage. Ensure sample management is performed per protocol requirements and sample data is accurately tracked.

Regulatory Oversight:

• Identify regulatory risk and implement mitigation strategies.
• Support external and internal regulatory audit activities and communications, in collaboration with the Regulatory Affairs department as appropriate.
• Assist in the coordination of onsite monitoring visits, attending the visit when needed. Ensure all follow-up work is completed in accordance with monitoring letter.
• Complete External Audit Report for FH Board of trustees twice yearly.
• May serve as primary regulatory manager for repository protocols.
• Provide coverage for program regulatory coordinator when needed.

This position requires routine on-site work. Work hours may exceed 40 hours per week and may be deadline dependent. There may be deadlines that require a flexible schedule in order to accommodate, such as patient coordination needs, study sponsor deadlines, research program needs, grant deadlines, and faculty needs. A hybrid working arrangement is possible once incumbent is fully established within the role.

Qualifications

Required Experience

• Bachelor's degree or equivalent experience
• 5 years' experience in all phases of clinical trial/protocol management
• Minimum 1 year of staff management or supervisory experience
• Significant experience with regulatory oversight of clinical research
• Strong communication and organizational skills
• Knowledge of medical terminology
• Demonstrated ability to create and build collaborative relationships, problem-solve, prioritize multiple competing tasks in a dynamic environment, and work independently
• Proficient in MS office

Preferred Experience:

• Advanced Degree (Master's level or higher)
• Certified Clinical Research Coordinator (ACRP), Certified Clinical Research Professional (SOCRA), or equivalent research certification
• Prior exposure to Oncology
• Experience in CTMS/Oncore/REDCap/WorkDay systems
• Pharmaceutical industry experience desired
• Compliance-focused and familiar with building quality systems
• Ability to work with limited supervision and ambiguous direction

Please include a cover letter with your application.

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 $106,427 to $168,223 and pay offered will be based on experience and qualifications.

This position may be eligible for relocation assistance.

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 hrops@fredhutch.org or by calling 206-667-4700.