Clinical Trial Manager II

Found in: Resume Library US A2 - 1 week ago


Seattle Washington, United States Seattle Children's Hospital Full time
Responsibilities:
Coordinate and manage the planning, implementation and completion of single and multi-site clinical trials for Seattle Children's Immunotherapy Integration Hub. 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, resources, and oversee vendor activities(s) as assigned and/or applicable. Development and maintain study documents including protocols, plans, manuals, subject materials and forms. Support and train and mentor junior staff. Ensure trials to meet 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.

Requirements:
Required Education/Experience:

Bachelor’s Degree in biological sciences or health-related field.

Minimum of three (3) years’ experience as a clinical research associate or equivalent position, including at least two (2) years managing clinical studies for a sponsor organization, or equivalent application of research methodology in a clinical research setting.

Experience in lead roles 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.

Required Credentials:

N/A.

Preferred:

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 managing components of complex oncology clinical trials.

Experience overseeing vendor(s), eg,Contract Research Organization (CRO).

Experience with managing components of pediatric clinical trials.

Experience working in an academic setting.

Experience working with Lean or Six Sigma principles.

Min to Max Hourly Salary:
$48.91 - $73.36 /hr

Min to Max Annual Salary:
$(phone number removed) - $(phone number removed) /yr

Salary Information:
This compensation range was calculated based on full-time employment (2080 hours worked per calendar year). Offers are determined by multiple factors including equity, skills, experience, and expertise, and may vary within the range provided.

Disclaimer for Out of State Applicants:
This compensation range is specific to Seattle, positions located outside of Seattle may be compensated differently depending on various factors.

Benefits Information:
Seattle Children’s offers a generous benefit package, including medical, dental, and vision plans, 403(b), life insurance, paid time off, tuition reimbursement, and more. for more information.

About Us:
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

 

As one of the nation's top five pediatric research centers, Seattle Children's Research Institute is dedicated to providing hope, care, and cures to help every child live the healthiest and most fulfilling life possible.

 

Our investigators are involved in hundreds of projects that cover every phase of research, from studying how diseases work to improving investigational therapies. They have pioneered groundbreaking cystic fibrosis treatments and cutting-edge cancer therapies that help a child's immune system defeat cancer, and made other major contributions to pediatric medicine. 

 

Researchers work in close collaboration with one another, their colleagues at partner institutions including the  and  and our healthcare providers at Seattle Children's Hospital, one of  top children's hospitals. This collaboration is one of our key strengths, allowing our faculty to draw on a variety of disciplines and techniques as they pursue solutions to some of medicine's most complex problems.

 

We are committed to not only treating disease but to eliminating it. Help us achieve our vision of being a worldwide leader in pediatric research aimed to improve the health and well-being of children. If you are interested in a challenging career aimed at groundbreaking research, Seattle Children's Research Institute is the place for you.

Our Commitment to Diversity:
Our community welcomes diverse experiences, backgrounds, and thoughts as this is what drives our spirit of inquiry and allows us to better connect with our increasingly diverse patients and families. Our organization recruits, employs, trains, compensates, and promotes without regard to race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

The people who work at Seattle Children's are members of a community that seeks to respect and celebrate all the qualities that make each of us unique. Each of us is empowered to be ourselves within this community, which cultivates and promotes equity, diversity, and inclusion at all levels.

Seattle Children's is proud to be an Equal Opportunity Workplace and Affirmative Action Employer.



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