Overview:
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 Director of Clinical Trial Coordination provides leadership and oversight to oncology clinical trial management activities across the Fred Hutch, University of Washington, and Seattle Children’s Cancer Consortium (“Cancer Consortium”). The position is responsible for directing the work of 4+ clinical research teams that support the Phase I Program trial portfolio and disease-based program portfolios that include phase I-IV therapeutic, multi-site industry trials, investigator-initiated trials, and national cooperative group trials. As a key leader in the Cancer Consortium’s central clinical trials office, Clinical Research Support (CRS), the Director is responsible for driving strategic initiatives, fostering collaboration, and ensuring operational success across multiple research programs. The position reports to the Vice President of Clinical Research and works in close collaboration with the Clinical Research Program Medical Director.
Responsibilities:
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 Director of Clinical Trial Coordination provides leadership and oversight to oncology clinical trial management activities across the Fred Hutch, University of Washington, and Seattle Children’s Cancer Consortium (“Cancer Consortium”). The position is responsible for directing the work of 4+ clinical research teams that support the Phase I Program trial portfolio and disease-based program portfolios that include phase I-IV therapeutic, multi-site industry trials, investigator-initiated trials, and national cooperative group trials. As a key leader in the Cancer Consortium’s central clinical trials office, Clinical Research Support (CRS), the Director is responsible for driving strategic initiatives, fostering collaboration, and ensuring operational success across multiple research programs. The position reports to the Vice President of Clinical Research and works in close collaboration with the Clinical Research Program Medical Director.
- In partnership with the Program Medical Director, formulate and implement operational strategies for oncology clinical research programs that align with individual program goals and organizational priorities.
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Oversee study management activities ensuring efficient trial activation and conduct in compliance with applicable regulations, guidelines, institutional policies, and standard operating procedures (SOPs).
- Mentor, support, and develop staff, including direct management of research managers across the UW and Fred Hutch.
- Direct work to align team structure, processes, and systems across teams.
- Foster culture of collaboration with clearly defined engagement models between research, clinic, and administrative staff.
- Direct program resource planning and management based on trial portfolio, direction and growth; partner with finance team to ensure adherence to budgets and adjust resourcing plans accordingly.
- Identify opportunities to improve efficiency, and enhance the overall quality of clinical trial operations, recommend solutions, and lead changes that may include team structure, processes improvements, or adoption of technology solutions.
- Work in close partnership with other central teams including protocol development, study startup, regulatory affairs, and compliance to ensure integrated, compliant, and efficient end-to-end trial management.
- Define and report-out program metrics and key performance indicators for institutional and Cancer Consortium leadership, and faculty.
- Establish strong relationships and effective collaborations with Cancer Consortium stakeholders (e.g., investigators, clinical, research, and administrative staff and leadership) working across the institutions, and external partners (e.g., sponsors, CROs, vendors).
- Lead, provide guidance, and assist departmental and Cancer Consortium clinical research initiatives and operations as needed.
MINIMUM QUALIFICATIONS:
- Bachelor's degree or equivalent qualification or experience
- Minimum three years of staff management experience and five years of experience in all phases of clinical trial/protocol management
- Ability to identify and resolve complex clinical trial issues
- Demonstrated knowledge of clinical trial design, operations, and regulatory requirements
- Working understanding of applicable regulations and guidelines including FDA, ICH GCP, and HHS
- Strong leadership, organizational, and multitasking skills are essential
- Excellent written and verbal communication skills
- Proven ability to develop effective, collaborative relationships at all levels
- Ability to train and mentor staff
PREFERRED QUALIFICATIONS:
- Advanced degree preferred
- Clinical research-related certification preferred
- Experience overseeing study teams in an academic research institution preferred
- Deep understanding of therapeutic oncology clinical trial operations and phase I trial requirements preferred
- Experience working in Epic preferred
- Experience working with clinical trial software including an electronic regulatory binder system, electronic data capture systems (EDCs), and a Clinical Trial Management System (CTMS) preferred
The annual base salary range for this position is from $161,450 to $269,048, and pay offered will be based on experience and qualifications. This position may be eligible for relocation assistance. This position may be eligible for sign on bonus.
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), and paid parental leave (up to 4 weeks).
Additional Information: We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. 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 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.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), and paid parental leave (up to 4 weeks).
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