Regulatory/Quality Project Manager

Job ID
17573
Type
Regular Full-Time
Company
Fred Hutchinson Cancer Research Center
Location
US-WA-Seattle
Category
Project Management

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 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.


Job Summary

The Regulatory/Quality Project Manager position will support the HVTN/CoVPN’s Leadership Operations Center (LOC) for Quality & Regulatory Affairs, as needed, by managing the operations of projects or studies. The incumbent works under the direction of the HVTN/CoVPN Director of Quality & Regulatory Affairs. Special skills and knowledge are applied in managing research and administrative activities, such as developing policies, procedures, and methods for project/study implementation, as well as carrying-out complex clinical trials operations and research assignments.

Responsibilities

Perform some or all of the following responsibilities:

  • Set goals and timetables for proactively tracking sites’ target dates for regulatory and ethics body submissions and approvals and completion of Protocol Activation items in order to prevent delays in study start at sites
  • Trouble-shoot potential delays in Protocol Activation items by working with sites and other members of the LOC, Statistical Data Management Center, and Laboratory Center, and outside collaborators, as needed
  • Support the Director of Quality & Regulatory Affairs in project management tasks related to the Quality Management System and Trial Master Files
  • Support the Director of Quality & Regulatory Affairs in logistical planning for African regulatory/ethics engagement activities
  • Manage onboarding new sites to get them set up in HVTN/CoVPN’s regulatory tools, systems, and processes
  • Coordinate translation and distribution of safety-related documents to sites
  • Coordinate the regulatory aspects of specimen management, including tracking specimen destruction triggers and completing tasks associated with auxiliary studies
  • Work with protocol team leadership at DAIDS and DAIDS contractors to register clinical trials to NIH’s clinicaltrials.gov website
  • Compile Clinical Study Reports and facilitate applicable internal reviews
  • Manage submissions to the single IRB
  • Provide administrative support for external audits, ensuring professional and timely delivery of essential documents to auditors
  • Document operating procedures using SOPs, WPGs, and checklists so others may fill in if needed
  • Perform other tasks as assigned

Qualifications

Required:

  • BA/BS in related field
  • 3-5 years of post bachelor’s related project/study management experience in a research setting. Other relevant work experience may substitute.
  • Sharp critical thinking skills
  • High level of attention to detail and organization
  • Excellent written and verbal communication skills
  • Good interpersonal skills and an ability to maintain confidentiality are essential
  • Demonstrated ability to work independently and take initiative in a dynamic environment
  • High level knowledge of Microsoft applications, specifically Word, Excel, PowerPoint, Teams, and Outlook


Preferred:

  • MA/MS in a related field
  • 3 years of post-masters related project/study management experience in a research setting.
  • Experience in Lean methodologies highly desired
  • Knowledge of SharePoint, Blueworks, and SmartSheet

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.

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