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4 Found open positions

Fiscal and Contract Manager, HVTN

FH Vaccine and Infectious Disease Division
Category: Grants and Contracts
Seattle, WA, US
Job ID: 23073

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures for the world’s deadliest diseases and make life beyond cancer a reality.

 

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.   


The HIV Vaccine Trials Network (HVTN) is the world’s largest publicly funded multi-disciplinary international collaboration facilitating the development of vaccines to prevent HIV/AIDS. Most recently, the COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the US National Institutes of Health to respond to the global pandemic. Using the infectious disease expertise of their existing research networks and global partners, NIAID has directed the HVTN to utilize their experience and expertise to address the pressing need for vaccines and antibodies against the SARS-CoV-2 virus. The mission of CoVPN is to conduct Phase 3 Efficacy Trials to prevent infection and COVID-19 disease. CoVPN will work to develop and conduct studies to ensure rapid and thorough evaluation of United States government-sponsored COVID-19 vaccines and antibodies for the prevention of COVID-19 disease.

 

The Fiscal and Contract Manager is responsible for the clinical research financial management for the HIV Vaccine Trials Network (HVTN) and/or the CoVID Prevention Network (CoVPN) including the cooperative agreement, supplement and carry forward requests and many complex subcontracts. Incumbent works under the direction of the Director of Finance, the HVTN Executive Director and Principal Investigator for the HVTN Leadership Operations Center, referring issues and soliciting guidance as necessary, and coordinating the budget-related work of other staff.

Responsibilities

  • Administer and monitor CoVPN and/or HVTN budget(s), providing routine reports and projections to management.
  • Oversight in managing multiple large, complex multi-year awards from NIH/NIAID, Bill and Melinda Gates Foundation (BMGF), and other funders.
  • Provide financial support to CoVPN and/or HVTN clinical research sites around the world, including annual funding requests and monthly invoice/expense report review.
  • Maintain and enhance multiple record keeping and reporting systems for varied and complex sources of funding; develop procedures for implementation, execution, control, and review/audit of fiscal operations.
  • Responsible for providing clinical trial cost estimate to CoVPN and/or HVTN Leadership.
  • Manages contracts specialists to administer and monitor the CoVPN and/or HVTN national and international subcontracts, ensuring deliverables are timely, any contract requirements are observed, and payments are made.
  • Serves as CoVPN and/or HVTN fiscal liaison to cross-network fiscal working groups.
  • Act as CoVPN and/or HVTN liaison to FHCC Office of Sponsored Research, FHCC Finance, and other CoVPN and/or HVTN sites, providing information as needed for allocation of all funds.
  • Play a key role in the development or revision of policies and procedures, with the focus on those that guide the operations of the financial aspects of the network.
  • Supervise financial analyst, grants, and contracts personnel.
  • Work closely with the Director of Finance in coordination and collaboration of budget and financial activities for the Network.
  • Other duties as assigned.

Qualifications

Minimum Qualifications

  • Bachelor's degree required. Master’s in Business Administration or Public Administration preferred.
  • Minimum of 8 years’ experience in the Clinical Research field with specific experience working with grants and contracts (federal and foundation).
  • Supervisory experience required.
  • Experience with detailed financial analysis tools and reporting.
  • Strong computer skills—MS Word, Adobe Pro, and advanced knowledge of Excel required.
  • Excellent organizational skills, ability to prioritize work independently with strong attention to detail and superior analytical and problem-solving skills.
  • Excellent written and verbal communication skills.
  • Demonstrated ability to multi-task in a fast-paced, constantly evolving fiscal management environment.
  • Ability to work in collaboration with ancillary committees, investigators, research staff, supporting administration, and sponsors/funding agencies.
  • Demonstrated ability to work effectively in a team environment as well as individually.
  • Available for periodic travel to research sites in other countries.

Preferred Qualifications

  • Experience working with Uniform Guidance is highly preferred.
  • Experience with Hyperion, PeopleSoft and related databases is preferred.
  • Experience working internationally and/or working with non-U.S. organizations strongly preferred.

 

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

 

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Outreach Specialist

FH Vaccine and Infectious Disease Division
Category: Clinical Research Support Services
Seattle, WA, US
Job ID: 22147

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

 

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.   

 

The Seattle Vaccine Trials Unit (VTU), led by Dr. Julie McElrath, director of Fred Hutch division of Vaccine and Infectious Disease implements an array of studies researching HIV and other infectious diseases.  In the world of HIV vaccine research, the VTU is one of the 22 research sites within the HIV Vaccine Trials Network (HVTN), the world’s largest publicly funded multi-disciplinary international collaboration. The HVTN network is funded to conduct phase I, II, and III clinical trials designed to test the safety and efficacy of HIV vaccines. As a local site of the HVTN, the Seattle VTU works to enroll volunteers in a number of research studies.

 

Located on Seattle’s First Hill, the VTU is responsible for the recruitment, selection and enrollment of local volunteers and clinical monitoring of volunteers. Since opening in 1987, the Seattle VTU has worked with local community members who are interested in participating in research and has provided education to the local community.  We work with many community based organizations such as African American Reach and Teach MinistriesEntre HermanosGay City, Multicultural HIV/Hepatitis Action Network and Lifelong AIDS Alliance.

 

Together with the help of our volunteers, we hope to end the HIV/AIDS pandemic.

 

This is a temporary part-time, hourly position. Availability for Monday evening meetings and a flexible schedule will include weekday, nights and weekends on a “as needed” basis. Anticipated hours are roughly 10 hrs/week.

Responsibilities

The Seattle HIV Vaccine Trials Unit is seeking a committed, energetic person to join our community outreach team. 

 

The Outreach Specialist's primary responsibilities will be to recruit participants for our groundbreaking HIV vaccine studies and other studies conducted at the VTU.  Recruitment will occur in local venues that may include street locations, community events, community based organizations, public clinics as well as bars, dance clubs, and sex clubs. Recruitment efforts will focus on diverse populations according to the demands of the current studies.  Work will include some administrative tasks.

Qualifications

Minimum qualifications

  • Must be at least 21 years old
  • Possession of a high school diploma or equivalent
  • Excellent written and verbal communication skills
  • Must live in the general Seattle area or close proximity
  • Knowledge of and sensitivity to transgender, non-conforming, non-binary people as well as youth, racial, ethnic, cultural, and sexual diversity is essential
  • Candidates for the position must be willing to learn a variety of skills related to recruiting for clinical trials for healthy adults
     

Preferred qualifications

  • Previous experience recruiting for clinical trials
  • Familiarity with LGBTQ+ community venues strongly preferred or experience working with men who have sex with men (MSM) and/or transgender communities

 

Application instructions: please submit a cover letter and with your application for consideration

 

 

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

Protocol Development Manager, HVTN

FH Vaccine and Infectious Disease Division
Category: Project Management
Seattle, WA, US
Job ID: 23072

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures for the world’s deadliest diseases and make life beyond cancer a reality.

 

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.   


The HIV Vaccine Trials Network (HVTN) is the world’s largest publicly funded multi-disciplinary international collaboration facilitating the development of vaccines and antibodies to prevent HIV/AIDS. Most recently, the COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy and Infectious Diseases (NIAID) at the US National Institutes of Health to respond to the global pandemic. Using the infectious disease expertise of their existing research networks and global partners, NIAID has directed the HVTN to utilize their experience and expertise to address the pressing need for vaccines and antibodies against the SARS-CoV-2 virus. The mission of CoVPN is to conduct Phase 3 Efficacy Trials to prevent infection and COVID-19 disease. CoVPN will work to develop and conduct studies to ensure rapid and thorough evaluation of United States government-sponsored COVID-19 vaccines and antibodies for the prevention of COVID-19 disease. The HVTN has also expanded the scope of preventative infectious disease work to include the intersecting pandemic of TB by working with collaborators to evaluate novel TB vaccine approaches.

 

The HVTN/CoVPN conducts all phases of clinical trials, from evaluating experimental vaccines and other study products for safety and immunogenicity, to testing vaccine efficacy. The Protocol Development Manager (PDM) position provides a unique opportunity to work with leading world-class scientists and collaborators around the world and join the global team in discovering effective HIV, COVID-19, TB and other preventative vaccines and antibodies.

 

The PDM II manages the development of clinical trial protocols for HIV, COVID-19, TB and other vaccines and antibodies from concept to implementation, working with on-site and off-site protocol team members. The PDM II establishes and maintains relationships, expectations, timelines, and collaborations, with team members with a wide range of expertise. The PDM II may assist authors with the drafting and editing of concept sheets, concept proposals, and clinical protocols, including informed consent forms. The PDM II utilizes project management, interpersonal communication, and critical thinking skills to direct the protocol development process.

Responsibilities

  • Project manage, co-write, and direct development of clinical trial protocols for HIV, COVID-19, TB and other vaccines and investigational products from concept to implementation in conjunction with the Protocol Team Leader (PTL).
  • Establish and maintain relationships, expectations, and responsibilities with key opinion leaders/stakeholders with varying expertise and interests including the external partners of: principal investigators, vaccine developers, NIH/NIAID/DAIDS sponsor representatives (medical officers, project officers, pharmacists, and Regulatory associates), and other sponsors and/or funder representatives; as well as HVTN internal partners: laboratory staff, statistical and data management staff, regulatory affairs staff, trial operations and clinical staff, and community education staff.
  • Manage development of eCTD compliant documents and presentation materials for submission to sponsors, funders, national regulatory entities, and other key audiences.
  • Construct clinical development plans, including timelines, milestones, and key decision points.
  • Medical writing: coordinate, co-author and manage the development of drafting and editing of protocols, informed consents, and related documents. Manages all aspects of the clinical protocol development process.
  • Coordinate HVTN/CoVPN program initiatives encompassing multiple clinical trials, funders, and institutional stakeholders as requested.
  • Organize and facilitate program stakeholder meetings and protocol team meetings, which may include multi-day face-to-face meetings.
  • Drive protocol development and project timelines; establish team meeting agendas and track ensuing action items in coordination with PTL.
  • Orchestrate submissions, reviews, responses to reviewer comments, and reviewer signoffs of draft protocol documents from concept development through FDA submission.
  • Support study conduct following implementation by serving as a resource for the data management staff and clinical trial Project Managers as needed.
  • Assemble and process protocol modifications and amendments following implementation when required.
  • Manage special projects that may include:
    • Scientific writing, literature and data reviews, and grant and manuscript development support.
    • Compiling data and creating protocol and clinical development slides.
    • Cross-protocol continuous process-improvement activities.
    • Assist in the development of new or improvement of existing cross-unit processes as required.
    • Other project management duties as needed.
  • Provide mentorship and training for newer PDMs.
  • Serve as a resource to colleagues within and outside of the US regarding protocol and protocol-related document development, submissions, and control.
  • Attend twice-yearly HVTN/CoVPN Meetings (out-of-state and out-of-country) when travel restrictions are not in place.

Qualifications

  • PhD in immunology, biology, or related field, with two years of clinical trial research experience; or Masters in immunology, biology or related field with four years of clinical trial research experience required.
  • Knowledge of and experience with ICH guidelines, GCP, and the conduct, research methods and regulatory submissions and aspects of clinical trials.
  • Excellent writing skills and scientific vocabulary capable of effective verbal and written communication with clinical research staff, health professionals, and clinical scientists.
  • Scientific project management experience preferred.
  • Demonstrated experience in managing multiple, deadline-driven complex projects simultaneously with minimal supervision.
  • High degree of organizational skills, effective time management, logical thinking, and close attention to detail.
  • Extensive MS Word experience required.
  • Ability to work cross-functionally in a global network with off-site collaborators preferred.
  • Experience with SharePoint, Microsoft Teams, and a project management software tool are highly desired.

 

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

 

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Research Technician II-III - McElrath Laboratory

FH Vaccine and Infectious Disease Division
Category: Laboratory Research Sciences
Seattle, WA, US
Job ID: 22219

Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch’s global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world’s leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world’s deadliest diseases and make life beyond cancer a reality.

 

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.   

 


 

This research opportunity is with the McElrath laboratory, HIV Vaccine Trials Network (HVTN) and Coronavirus Prevention Network (CoVPN).  Our lab is recruiting a Research Technician to primarily perform assays to characterize antiviral T and B-cell responses. The technician will be expected to perform complex research assays, utilizing flow cytometry to evaluate vaccine-induced cellular immune responses in vaccine recipients participating in clinical trials of investigational vaccines for SARS-CoV-2/COVID-19, HIV, malaria, tuberculosis (MTB), and Ebola. They will be responsible for performing and coordinating the assays with other technicians and analyzing the data.  They will interpret and report on experimental results and assist with data presentation. They will assist in writing laboratory SOPs, reports, and other documentation.  They will report to a staff scientist and work closely with a technical team.

 

The HVTN’s mission is to facilitate the process of testing preventive vaccines against HIV/AIDS or other infectious diseases. The organization conducts all phases of clinical trials from evaluating experimental vaccines for safety and the ability to stimulate immune responses through to testing vaccine efficacy. The HVTN laboratory is responsible for conducting laboratory-based studies to evaluate the immunogenicity of investigational vaccines.

Responsibilities

  • Maintain a high level of accuracy for all work.
  • Work well as team-member, participate in positive communication, and foster an environment that allows all laboratory staff to work well together.
  • Independently perform flow cytometry, FACS sorting, and other experimental assays, such as MSD, ELISpot and ELISAs.
  • Perform flow cytometry (intracellular cytokine staining and FACS sorting), ELISPOT and MSD/Luminex/ELISAs for characterization and monitoring of T and B cell responses.
  • Proactively prepare reagents for experiments and for general lab use.
  • Troubleshoot and optimize experimental methods, results and analysis.
  • Maintain accurate documentation for experiments and quality control for the laboratory.
  • Carry out maintenance, trouble-shooting and QC of laboratory equipment.
  • Review the literature to stay informed on the HIV vaccine field or immunological assays.
  • May perform data analysis, interpretation, and statistical analyses.
  • Other duties as assigned.

Qualifications

  • 2 or more years of experience in a laboratory role.
  • Specific experience with flow cytometry, immunology, cellular assays, and tissue culture are preferred. 
  • Motivation, adaptability and ability to be a strong team player are essential, as is a keen interest in the HIV vaccine field.  
  • The candidate must be someone with great attention to details, well-organized, self-motivated, and able to efficiently manage time and experiments. 
  • Experience in a GLP or GCLP setting or clinical experience, with strong documentation skills is also desirable. 
  • Applicants must be willing to work with biohazardous/infectious agents (e.g., blood-borne pathogens, including HIV-1) and also be flexible and willing to work some evenings and weekends. 

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.
As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

 

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

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