Associate Director, Clinical Trial Coordination

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 worlds 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 worlds 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 Associate Director of Clinical Trial Coordination provides leadership and oversight to oncology clinical trial management activities across the Fred Hutch University of Washington and Seattle Childrens Cancer Consortium (Cancer Consortium). The position is responsible for directing the work of up to four 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 Consortiums central clinical trials office Clinical Research Support (CRS) the Associate Director is responsible for driving strategic initiatives fostering collaboration and ensuring operational success across multiple research programs. The position reports to the Senior Director of Clinical Trial Coordination and works in close collaboration with the Clinical Research Medical Director(s) of the relevant program(s).

• In partnership with the CTC Sr. Director and Clinical Research Medical Directors formulate and implement operational strategies for oncology clinical research programs that align with individual program goals and organizational priorities.
• 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 to align with documented best practices and standards.
  • Foster culture of collaboration with clearly defined engagement models between research clinic and administrative staff.
• With input from the Clinical Research Medical Directors and the CTC Sr. Director 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 or co-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.
• Track and report-out program metrics and key performance indicators (KPIs) for institutional and Cancer Consortium leadership and faculty; recommend metrics and KPIs to be standardized across teams.
• 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:

• Bachelors degree or equivalent education or experience
• Minimum six years of clinical trial management with three years of staff management experience
• 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 $149365 to $248913 and pay offered will be based on experience and qualifications.

This position may be eligible for relocation assistance.
This position is not eligible for H-1B sponsorship at this time.

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).