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 Hutchs 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 nations first cancer prevention research program, as well as the clinical coordinating center of the Womens Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.
The HIV Vaccine Trials Network (HVTN) is the worlds 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 Regulatory/Quality Project Manager position will support the HVTN/CoVPNs 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.
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/CoVPNs 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 NIHs 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
BA/BS in related field
3-5 years of post bachelors 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
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 firstname.lastname@example.org or by calling 206-667-4700.
At Fred Hutchinson Cancer Research Center, teams of world-renowned scientists and humanitarians work together to prevent, diagnose and treat cancer, HIV/AIDS and other diseases. Researchers are discovering new ways to detect cancers earlier, improve treatments, and learn how to prevent cancers from growing. Although Fred Hutchinson opened its doors in 1975, its history began about 20 years before that. In 1962 Fred Hutchinson envisioned a center devoted to studying cancer, a disease that took his brother’s life. Today Fred Hutchinson is contributing to the next waves of breakthrough treatments and prevention strategies. Fred Hutchinson collaborates with the Seattle Cancer Alliance, the National Cancer Institute, and the University of Washington.