LABORATORY OPERATIONS MANAGER

University of Washington   Seattle, WA   Full-time     Engineering
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Posted on July 8, 2020
Req #: 177701
Department: GLOBAL HEALTH: ICRC
Job Location: Harborview Medical Center
Posting Date: 03/09/2020 
Closing Info: Open Until Filled 
Salary: Salary is commensurate with experience and education 
Shift: First Shift 
Notes: As a UW employee, you will enjoy generous benefits and work/life programs.  For detailed information on Benefits for this position, click here.  

As a UW employee, you have a unique opportunity to change lives on our campuses, in our state and around the world. UW employees offer their boundless energy, creative problem solving skills and dedication to build stronger minds and a healthier world.

UW faculty and staff also enjoy outstanding benefits, professional growth opportunities and unique resources in an environment noted for diversity, intellectual excitement, artistic pursuits and natural beauty. All of which has allowed the UW to be nationally recognized as a “Great College to Work For” for six consecutive years. 

The Department of Global Health was established in 2007, bridging the schools of Medicine and Public Health, with a mandate to harness the expertise and interdisciplinary power of all UW schools and colleges. Our mission is to improve health for all through research, education, training, and service; to understand and address the causes of disease and health inequities at multiple levels; and to collaborate with partners to develop and sustain locally-led, quality health systems, programs and policies. Driven by tremendous interest among both students and faculty, the Department has grown explosively to more than 400 graduate students and hundreds more undergraduates. We have more than 380 faculty and 1,000 staff working on projects across 130 countries with our deepest ties in United States, Kenya, Uganda, Peru, Mozambique, India, South Africa, Tanzania, Ethiopia, and Nicaragua. At the Department of Global Health at the University of Washington, diversity is integral to excellence. The Department recognizes that disparities in health around the globe stem from inequity. The Department encourages and supports the multiple identities of staff, faculty and students including, but not limited to, socioeconomic status, race, ethnicity, language, nationality, sex, sexual orientation, gender identity and expression, culture, spiritual practice, geography, mental and physical disability and age. The Department strives to become a local, national, and international leader in developing and maintaining increased representation and recognition of each of these dimensions of diversity among its faculty, staff, and students.

The University of Washington International Clinical Research Center (ICRC) was established within the Department of Global Health in 2007. The Center currently has nineteen productive faculty members, approximately 30 highly competent staff who specialize in study operations, regulatory affairs, data management and analysis, and specimen repository operations. The overarching goals of the ICRC are to: 1) Conduct clinical research on HIV and other infectious diseases of public health significance, 2) Evaluate interventions to reduce the burden of disease, 3) Conduct observational analyses and translational research on pathogenesis and new intervention targets, and 4) Mentor graduate students and international collaborators in clinical research.

The University of Washington International Clinical Research Center is seeking a Laboratory Operations Manager to lead the laboratory and operational aspects of international multi-site research studies including clinical trial and observational studies. This role is responsible for clinical sample management and biobanking and will oversee coordination of operational activities along the value chain to ensure appropriate collection, delivery, and analysis of bio-samples globally with the highest standards of quality and procedural requirements. In this capacity, the Laboratory Operations Manager will work collaboratively with international collaborators, investigators, research personnel, contractors and vendors. This position demands a comprehensive understanding of regulatory requirements, international operations and research laboratory sample chain of custody and specimen preservation in a rapidly changing environment. This position reports to the Managing Director.

RESPONSIBILITIES:

Under direction from the Center’s Managing Director, the Laboratory Operations Manager will be responsible for the following activities, including, but not limited to:
Leadership and Management:
• Work as an integral part of the research team on multiple, varied research projects, supporting Principal Investigators and other research staff by providing timely and complete information about laboratory status and research activities
• Work independently to communicate with diverse stakeholders, internal and external to ICRC, interact closely with study research labs abroad, coordinate biological material shipments; respond to inquiries regarding specimens from internal and external departments; make decisions independently to prioritize requests
• Under minimal supervision, successfully lead laboratory activities forward from conceptual design through implementation to completion
• Establish site performance measures and reporting mechanisms designed to monitor progress toward objectives
• Supervise one staff, Repository Coordinator

Laboratory Operations
• Develop research implementation plans for all phases of lab activities including timelines, deliverables, and milestones. Oversee progress on these milestones.
• Organize research training plan and materials for laboratory sites, including Good Clinical Laboratory Practice (GCLP), study-specific training, IATA and others.
• Travel to sites in sub-Saharan Africa, and elsewhere as required, to provide laboratory monitoring and technical assistance.
• Manage specimen inventories, labeling, shipments from research sites, and distribution to laboratory collaborators
• Work closely with the Data and Operations team to spearhead development of specimen labeling systems, to ensure that specimens can be linked in FreezerWorks
• Resolve issues of supply procurement, labeling, shipment, and inventory to ensure uninterrupted activities
• Ensure that specimen shipments from study sites occurs at required times and to maintain a tracking system to monitor repository inputs and outputs
• Coordinate the development of templates for SOPs for site adaptation as appropriate
• Responsible for safely and correctly handling and processing clinical specimens and purified DNA for subsequent testing and analysis. This will include sub-aliquoting clinical specimens and purified DNA, safely and accurately processing the specimens while maintaining specimen integrity
• Oversee the work of the Repository Coordinator, who is responsible for receiving, scanning and coordinating shipment of specimen to contract labs. Troubleshoot problems with shipping labs, reviewing charges incurred for specimen shipping
• Updating and curating the specimen tracking database, spreadsheets and other computer applications to enter and retrieve data

Quality Assurance
• Participate in quality management system and continuous improvement endeavors, including laboratory certification and accreditation management activities, audit preparation, and team member recruitment activities, participate in customer and regulatory reviews; follow departmental work instructions, SOP’s, safety regulations and standards to perform assigned tasks
• Maintain quality control and quality assurance records including media preparation, temperature charts and instrument calibration when needed
• Operate, calibrate and maintain laboratory equipment such as conductivity meter, pH meter, pipettors and thermometers.
• Perform general laboratory maintenance including washing and autoclaving glassware, receiving and sending packages, maintaining temperature logs/charts of laboratory equipment
• Work with building engineers, maintenance personnel and service providers, and University, state and federal regulatory officials, to maintain certifications and authorizations needed for uninterrupted activities
• Ensure EQA surveillance is maintained

REQUIREMENTS:
• Master’s degree in public health and/or scientific field of study or equivalent experience is required
• Minimum of 5 years of professional experience in clinical laboratory, research laboratory or biosample management
• Strong proficiency in GCLP, ICH, IATA guidelines and regulatory procedures with the ability to train site personnel
• Project Management skills with a proven track record of meeting milestones and timelines
• Self-motivated, resourceful with strong organizational skills and able to multi-task and work collaboratively and effectively in complex, multi-departmental, cross-functional teams
• Knowledge of the Microsoft Programs and data entry including: Access, Word, Excel and PowerPoint
• Knowledge of general freezer functions and maintenance
• Diplomatic skills, excellent judgement, proven ability to communicate effectively and present site performance and contract research organization performance for internal review
• Excellent written and oral communication skills

Equivalent education/experience will substitute for all minimum qualifications except when there are legal requirements, such as a license/certification/registration.

DESIRED EXPERIENCE
• Use of Laboratory Information Management Systems, like FreezerWorks sample inventory management systems
• Relevant experience working in developing countries, especially Africa is highly desirable
• Ability to travel to Africa or elsewhere as needed several times per year

Application Process:
The application process for UW positions may include completion of a variety of online assessments to obtain additional information that will be used in the evaluation process.  These assessments may include Workforce Authorization, Cover Letter and/or others.  Any assessments that you need to complete will appear on your screen as soon as you select “Apply to this position”. Once you begin an assessment, it must be completed at that time; if you do not complete the assessment you will be prompted to do so the next time you access your “My Jobs” page. If you select to take it later, it will appear on your "My Jobs" page to take when you are ready. Please note that your application will not be reviewed, and you will not be considered for this position until all required assessments have been completed.

Committed to attracting and retaining a diverse staff, the University of Washington will honor your experiences, perspectives and unique identity. Together, our community strives to create and maintain working and learning environments that are inclusive, equitable and welcoming.

The University of Washington is a leader in environmental stewardship & sustainability, and committed to becoming climate neutral.

The University of Washington is an equal opportunity, affirmative action employer. To request disability accommodation in the application process, contact the Disability Services Office at 206-543-6450 / 206-543-6452 (tty) or dso@uw.edu.