Description
Hope. Care. Cure. These three simple words capture what we do at Seattle Children’s – to help every child live the healthiest and most fulfilling life possible. Are you ready to engage with a mission-driven organization that is life-changing to many, and touches the hearts of all? #HOPECARECURE
Responsibilities
Under supervision, coordinate and manage the planning, implementation and completion of single and multi-site clinical trials for Seattle Children's. Ensure research projects are conducted in compliance with applicable federal and local regulations, ICH/GCP, organization policies, and institutional/ departmental guidelines. Manage and monitor clinical sites and oversee vendor activities as assigned. Development and maintain study documents including protocols, plans, manuals, subject materials and forms. Support trials to meet Sponsor obligations for clinical trial implementation, including determined timelines for key milestones and deliverables. Identify and implement process improvement ideas in collaboration with department staff. Assist with development of department infrastructure as required.
Required Education/Experience
- Bachelor’s Degree in biological sciences or health-related field or equivalent experience.
- Minimum of two (2) years’ experience as a clinical research associate or equivalent position, including at least one (1) year managing clinical studies for a sponsor organization, or equivalent application of research methodology in a clinical research setting.
- Experience working in a matrixed environment.
- Experience in Phase 1 & 2 clinical research.
- Experience developing study materials (eg, protocols, plans, manuals).
- Experience evaluating site performance against established criteria.
Preferred
- Five (5) years of related experience in an FDA-GCP regulated industry.
- Clinical Research Associate certification.
- Masters Degree in biological sciences or health-related field.
- Experience with complex oncology clinical trials.
- Experience working with vendor(s), eg,Contract Research Organization (CRO).
- Experience with pediatric clinical trials.
- Experience working in an academic setting.
- Experience working with Lean or Six Sigma principles.
