The Department of Laboratory Medicine and Pathology serves as a regional resource for clinical laboratory services required for patient care, research and educational programs in laboratory medicine and pathology. The department now employs 900 people who work at the award-winning University of Washington Medical Center (ranked among the top medical centers in the United States as rated by U.S. News & World Report), Harborview Medical Center (the region's only Level I Trauma center, known for innovations and excellence in trauma care and its centers of emphasis: Trauma, Burn, Neurosciences, AIDS/STD CARER, and mentally- and medically- vulnerable populations.), and many other clinical and research facilities in the area. The University of Washington (UW) is proud to be one of the nation’s premier educational and research institutions. Our people are the most important asset in our pursuit of achieving excellence in education, research, and community service. Our staff not only enjoys outstanding benefits and professional growth opportunities, but also an environment noted for diversity, community involvement, intellectual excitement and natural beauty.
Our Laboratory Medicine and Pathology department has an outstanding opportunity for a Full-time (100%) Clinical Trials Project Manager . The Clinical Trials Project Manager will serve as project manager for all clinical trials and research studies performed in the Virology Laboratory in Laboratory Medicine. This position plays a key role in the management of the clinical trials and research studies, including regular communication with laboratory faculty and staff, and frequent interaction with study investigators and project staff. This position will provide oversight to ensure completion of defined timelines and milestones of each study. There are many moving parts that require exceptional organization and management to ensure successful execution of the studies with full compliance to institutional and regulatory agency policies.
RESPONSIBILITIES Study Initiation Duties
Coordinate with study sponsors (UW and external) regarding research and service agreements, including statements of work, legal terms, budget approval, etc.
Monitor the approval process for agreements at UW and outside sponsors.
Coordinate the execution of Material Transfer Agreements (MTAs) between outside parties and UW.
Assist with preparation of budget estimates for studies.
Oversee the successful execution of each study by monitoring and analyzing project plans and implementing project initiatives and timelines.
Understand research timelines and milestones goals and ensure that projects are executed successfully and completed within time frames.
Conduct weekly meetings with sub-teams on their progress.
Conduct weekly meetings with outside sponsors on the status of the projects.
Effectively liaise between and across Investigators, study staff, participant sites, and funders to communicate research objectives, priorities, and/or changes based on analysis of project plans and progress.
Work with QA Manager to establish GCLP infrastructure and maintain compliance in performance of studies.
Work with Division Administrator to understand research fiscal management policies and practices.
Effectively manage project budget(s) as delegated.
Work collaboratively with study sponsors, Virology faculty and staff, Specimen Processing, and Laboratory Medicine and Pathology IT.
Manage disposition of study materials (sample disposition and record archiving).
Responsible for developing internal and external reporting on project milestones, spending, and outcomes.
Accurately track reports per sponsor guidelines.
Initiate and compile necessary documents and progress report materials.
Bachelor’s Degree in Biology, Molecular Biology, Microbiology, Chemistry or a related field AND 2-3 years experience.
An equivalent combination of education and experience may substitute for stated requirements.
Experience working in a clinical laboratory testing and workflow environment.
Experience with Laboratory Information Systems (LIS)
The ideal candidate will be self-motivated, with the ability to adjust to evolving program needs, use available resources to solve problems, and take initiative regarding ideas, suggestions, or solutions to best meet PI, program, and unit goals.
Excellent time-management and organizational skills and the ability to independently manage work priorities across multiple complex projects, meeting stringent timelines.
Ability to perform tasks independently with precision, accuracy, and meticulous attention to detail in an intense work environment.
Strong interpersonal and collaborative skills to work with large, diverse groups, strong interpersonal skills, excellent written and oral communication.
Experience with Good Clinical Laboratory Practice (GCLP) standards
Experience with standard office software (e.g., Word, Excel, Access), email, financial modeling and budget preparation in Excel.
CONDITIONS OF EMPLOYMENT
It will be necessary to work in other departmental locations in order to meet patient service requirements, especially at Harborview Medical Center. In addition, less frequent work effort will be required at other UW School of Medicine locations (e.g., South Lake Union) and Seattle-area healthcare institutions.
Will be considered essential staff and as such will be required to report to work when scheduled despite inclement weather.
Must be able to meet with all shifts on a regular basis
Founded in 1861, the University of Washington is one of the oldest public institutions in the west coast and one of the preeminent research universities in the world. The University of Washington is a multi-campus university comprised of three different campuses: Seattle, Tacoma, and Bothell. The Seattle campus is made up of sixteen schools and colleges that serve students ranging from an undergraduate level to a doctoral level. The university is home to world-class libraries, arts, music, drama, and sports, as well as the highest quality medical care in Washington State and a world-class academic medical center. The teaching and research of the University’s many professional schools provide undergraduate and graduate students the education necessary toward achieving an excellence that will serve the state, the region, and the nation. As part of a large and diverse community, the University of Washington serves more students than any other institution in the Northwest.