Clinical Trial Preceptorship Lead - QC

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 Trial Coordination (CTC) QC and Preceptorship Lead works closely with clinical research teams, directly supporting the development and delivery of training, resources, and educational materials. Reporting to the Clinical Trial Coordination (CTC) Onboarding and Preceptorship Manager this role is key in ensuring that all clinical research coordinators and staff are equipped with the necessary tools, knowledge, and guidance to successfully perform their duties. The Training Coordinator will provide on-the-ground support, monitor the application of training in real-world settings, troubleshoot complex cases, and assist in the development of training resources and standard operating procedures. This role is designed for someone who is hands-on and enjoys directly engaging with research staff to identify needs and drive improvements in clinical research practices.'

This position will be onsite.

Cover letters are optional but highly encouraged.

Onboarding and Leadership of new team members.

Lead the onboarding and training of new hires, ensuring they are fully equipped with the tools, knowledge, and resources needed to succeed during onboarding and throughout continued education.
• Provide hands-on leadership by shadowing coordinators during initial study visits to ensure strict adherence to processes and protocols, addressing any challenges in real-time.
• Monitor and evaluate coordinators' work ensuring accuracy, efficiency, and protocol compliance. Take immediate action to correct any deviations through targeted coaching or escalation to study team managers.
• Directly troubleshoot and guide coordinators on complex tasks, including regulatory compliance, patient management, data collection, and protocol implementation, ensuring seamless execution.
• Ensure coordinators are aligned with the most current guidance documents, reinforcing best practices during onboarding and through continued education.
• Deliver targeted, real-time feedback during early participant and protocol coordination, driving immediate improvements in performance, and understanding.
• Set the bar for leadership during onboarding focusing on structured training and immediate integration into clinical practices.
• Collaborate with investigators, team managers, and leads to identify and correct trends across teams.
• Design and implement standardized evaluation of clinical research competencies to confirm staff understanding and implementation of complex research tasks.
• Mentor and coach clinical research coordinators, providing leadership that fosters professional growth and operational excellence.

Resource and Process Development

• Drive the development and continuous improvement of training resources, working closely with the Manager of Training and Preceptorship to ensure they align with evolving needs and best practices.
• Design and implement new training and operational tools to ensure CRCs maintain familiarity with basic and complex research tasks.
• Review, update, and create standardized tools, templates, and checklists to enhance operational efficiency and consistency across the team.
• Take ownership of the development of a Clinical Research Coordinator Handbook, ensuring it remains up-to-date and serves as an authoritative resource for all team members.

Team Collaboration and Resource Development

• Lead strategic discussions with team members and stakeholders to identify gaps in training, resources, and operational processes.
• Collaborate with the Manager of Training and Preceptorship and other leaders to ensure that resource development is closely aligned with the overall training strategy and organizational goals.

Continuous Improvement and Reporting

• Provide actionable feedback and recommendations to the Manager of Training and Preceptorship based on observations and team performance, driving ongoing improvements in training programs.
• Monitor the effectiveness of corrective actions (CAPAs), ensuring that improvements are fully integrated into future training and team operations.
• Leverage performance metrics to identify and address new training opportunities, continually evolving the training approach depending on departmental needs.
• Serve as an on-going mentor for newer CRCs for managing and working with computer application specialists to ensure consistency between paper and electronic data systems.

Other Responsibilities

• Support audits and assessments to ensure that training standards and regulatory compliance are consistently met across the team.

MINIMUM QUALIFICATIONS:

• Bachelor's degree in Life Sciences, Social Sciences, Healthcare, or a related field.
• Minimum 5 years of experience in clinical research, research, or healthcare work, or related fields with a preferred focus onclinical trial coordination, monitoring, or training.
• Proficiency in content creation, including expertise in writing, content design, and user experience.
• Experience working directly with clinical research coordinators, including observation of their work, troubleshootingcomplex cases, and providing hands-on support.
• Previous experience in the development or implementation of training programs or resources is highly desirable.
• Strong knowledge of clinical research processes, GCP (Good Clinical Practice), and regulatory requirements.

PREFERRED QUALIFICATIONS:

• Certification in Clinical Research (e.g., CCRC, CCRP)
• ACRP-CCRC or SOCRA-CCRC
• Experience working directly with clinical research coordinators, including observation of their work, troubleshooting complex cases, and providing hands-on support

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 $77,976 to $112,674, 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).