Clinical Research QC and Preceptorship Lead

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 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 Clinical Research Quality Control (QC) and Preceptorship Lead partners closely with clinical research teams to support the development implementation and continuous improvement of training programs educational resources and operational tools. Reporting to the Clinical Research Training and Preceptorship Manager this role is key in ensuring that all clinical research coordinators and personnel have the knowledge skills and guidance needed to successfully conduct high-quality research in compliance with institutional regulatory and study-specific requirements. The Clinical Research QC and Preceptorship Lead 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 position is well suited for an individual who enjoys mentoring others fostering professional growth collaborating across teams and driving continuous improvement through direct engagement with research personnel and day-to-day operations.

At Fred Hutchinson Cancer Center all employees are expected to demonstrate commitment to our values of collaboration compassion determination excellence innovation integrity and respect.

Responsibilities

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 Tools and Resources ensuring they remain up-to-date and serves as authoritative resources 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.
• Maintain an active portfolio of clinical research studies or assume responsibility for assigned studies as determined by departmental needs in order to support operational coverage maintain subject matter expertise and inform training and quality improvement activities.
• Other duties as assigned.

Qualifications

MINIMUM QUALIFICATIONS:

• Education: Bachelors degree in Life Sciences Social Sciences Healthcare or a related field.
• Minimum 3 years of experience in clinical research research or healthcare work with a focus on clinical trial coordination monitoring or training.
• Experience working directly with clinical research coordinators including observation of their work troubleshooting complex cases and providing hands-on support.
• Strong knowledge of clinical research processes GCP (Good Clinical Practice) and regulatory requirements.

PREFERRED QUALIFICATIONS:

• Certification in Clinical Research (e.g. CCRC CCRP) preferred.
• Previous experience in the development or implementation of training programs or resources is highly desirable.

The annual base salary range for this position is from $80172 to $117811 and pay offered will be based on experience and qualifications.

Although Fred Hutch is not sponsoring most H-1B visas at this time candidates who already hold an H-1B sponsored by another organization and are currently in the U.S. may be eligible for this position.

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 or by calling .