Overview: Responsibilities:

The Laboratory Protocol Coordinator is an experienced contributor and will coordinate and support the laboratory studies for the HIV Vaccine Trials Network (HVTN) and Coronavirus Prevention Network protocols (clinical trials). The incumbent works under the direction of the Laboratory Protocol Operations Supervisor. The Laboratory Protocol Coordinator will participate in HVTN conference calls and meetings, prepare written reports and oral presentations, and as necessary, assist with grant applications. They will coordinate with Statistical Center for HIV/AIDS Research and Prevention (SCHARP), protocol teams, clinical trial sites and study sponsors on protocol operations, data transfer, analysis and presentations.

• Represent the HVTN/CoVPN Laboratory Center on protocol teams.
• Establish immunological assays and corresponding specimen needs for each study. Contribute to completion and maintenance of central assay plan.
• Serve as lab protocol liaison to other protocol team members, Center departments, funding sources, affiliated individuals or institutions, and outside organizations.
• Assist with writing, reviewing, producing and updating Study Manual of Operations.
• Prepare operational plans for specimen collection and processing at the clinical research sites.
• Maintain study materials for laboratory-related procedures, including instructions and documents for the clinics and processing laboratories.
• Contribute to case report form designs.
• Prepare and maintain laboratory study cost estimates.
• Participate in HVTN conference calls and meetings.
• Troubleshoot operational details of protocols with HVTN and SCHARP groups.
• Provide ongoing consultation on protocol laboratory related issues to protocol teams, network partners, sponsors and internal partners.
• Monitor and work with sites, including providing training, to ensure quality specimen collection and handling

• Create and maintain study materials for laboratory-related procedures, including instructions and documents for the clinics and processing laboratories.
• Represent the HVTN/CoVPN Laboratory Center on protocol teams.
• Establish immunological assays and corresponding specimen needs for each study. Contribute to completion and maintenance of central assay plan.
• Serve as lab protocol liaison to other protocol team members, Center departments, funding sources, affiliated individuals or institutions, and outside organizations.
• Assist with writing, reviewing, producing and updating Study Manual of Operations.
• Prepare operational plans for specimen collection and processing at the clinical research sites.
• Maintain study materials for laboratory-related procedures, including instructions and documents for the clinics and processing laboratories.
• Contribute to case report form designs.
• Prepare and maintain laboratory study cost estimates.
• Participate in HVTN conference calls and meetings.
• Troubleshoot operational details of protocols with HVTN and SCHARP groups.
• Provide ongoing consultation on protocol laboratory related issues to protocol teams, network partners, sponsors and internal partners.
• Monitor and work with sites, including providing training, to ensure quality specimen collection and handling

Qualifications:

• Bachelor’s degree or equivalent experience in biological, social or physical science.
• One year of regulatory or clinical trials and/or prevention study management experience
• Excellent written and oral communication is required.
• Strong background in collaborative team leadership and project completion.

• Bachelor’s degree or equivalent experience in biological, social or physical science.
• Two years of regulatory or clinical trials and/or prevention study management experience
• Previous experience with protocol design and review required.
• Work under minimal supervision, and ability to create and manage project schedules, including tasks, deliverables, milestones and schedules.

• Experience in HIV-1 or SIV/macaque models.
• Prior experience as a project manager, laboratory technician, medical technologist or research associate.
• Background in laboratory assays such as, ELISA, T and B cell flow cytometry, antibody neutralization, pathogen genome sequencing, HIV diagnostics or pre-clinical trials can be beneficial.
• Experience with MS Office or MS Project.
• Work under minimal supervision, and ability to create and manage project schedules, including tasks, deliverables, milestones and schedules.
• Experience with GLPs and GCPs, CLIA and/or other laboratory certifications a plus.

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), paid parental leave (up to 4 weeks), and partially paid sabbatical leave (up to 6 months).

Our Commitment to Diversity: We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. 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 are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and 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 our Employee Services Center at hrops@fredhutch.org or by calling 206-667-4700.