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HIV Diagnostics Project Manager

HIV Diagnostics Project Manager

Job ID 
11280
Type 
Regular Full-Time
Company 
Fred Hutchinson Cancer Research Center
Location 
US-WA-Seattle
Category 
Clinical Research Support Services

More information about this job

Overview

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first cancer prevention research program, as well as the clinical coordinating center of the Women’s Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

 

The HIV Vaccine Trials Network (HVTN) is an international collaboration of scientists and educators searching for an effective and safe HIV vaccine. The HVTN’s mission is to fully characterize the safety, immunogenicity, and efficacy of HIV vaccine candidates with the goal of developing a safe, effective vaccine as rapidly as possible for prevention of HIV infections globally. Our organization conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy.

HIV Diagnostics in the context of vaccine and antibody mediated prevention trials is complex and requires significant oversight and expertise.

 

The HVTN employs four regional laboratories to perform the diagnostics for trials conducted in the U.S., Europe, Africa, and South America. These laboratories utilize the HVTN HIV Algorithm Workflow System (HAWS), which guides the laboratories through the diagnostics algorithms and creates reports for the clinics and independent adjudicators. All data from the HVTN diagnostic laboratories is uploaded to and analyzed by the HVTN Statistical Data Management Center.  Clinical reports are distributed via a secure web-based system. Diagnostic testing includes multiple different serologic tests as well as assays for HIV RNA and DNA. Additional assays for low copy number RNA and viral outgrowth are currently under development and will be added to the diagnostic program in the future.

Responsibilities

The HIV Diagnostics Project Manager will report to the HVTN Associate Director of Laboratory Operations. The incumbent will liaise directly with the P.I.s and laboratory managers of the four regional diagnostics laboratories for oversight of conduct of the HIV diagnostics as well as specimen management and data reporting.  He/She will also assist clinical sites with any questions related to specimen collection or results reporting.  He/She will monitor the HVTN HIV Diagnostic adjudication system and work with the adjudicators and programmers to address any problems in data upload or resolution of determinations.

Responsibilities:

  • Manage updates and version control of the HVTN diagnostic algorithms
  • Manage updates and changes to the electronic HIV Algorithm Workflow System (HAWS)
  • Assist the statistical data management center (SDMC) with analysis of diagnostic data
  • Oversee and track the adjudication process for efficacy trials, oversee updates and changes to the electronic adjudication system
  • Communicate with adjudicators regarding outstanding or discrepant adjudications
  • Monitor testing data to ensure all testing is accurate and up to date.
  • Schedule and lead calls with the HIV diagnostics laboratories to receive updates and address any pending issues
  • Communicate with Laboratory P.I.s regarding equipment and staffing needs for HVTN trials
  • Work with laboratories to establish diagnostic kit selection for evaluation of seroreactivity.
  • Develop standard operating procedures and work practice guidelines for all processes related to testing algorithms, adjudication, data reporting and communications with clinical trial sites.
  • Ensure the HIV Diagnostics section of the HVTN Manual of Operations is up to date
  • Manage analysis and distribution of end-of-study reports on vaccine induced seroreactivity
  • Potential to present at national and international conferences
  • Be a part of publishing manuscripts related to HIV diagnostics in setting of HIV vaccine and antibody mediated prevention clinical trials.

Qualifications

PhD or Masters degree with appropriate experience may be considered.

Experience in HIV Diagnostic testing preferred.

Experience in a CLIA/CAP certified laboratory preferred.

Background in HIV virology and immunology preferred.

Our Commitment to Diversity

We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, 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 escmail@fredhutch.org or by calling 206-667-4700.