Fred Hutchinson Cancer Research Center (Fred Hutch), home of three Nobel laureates, is an independent, nonprofit research institution dedicated to the development and advancement of biomedical research to eliminate cancer and other potentially fatal diseases. Recognized internationally for its pioneering work in bone-marrow transplantation, the Centers five scientific divisions collaborate to form a unique environment for conducting basic and applied science. The Center, in collaboration with its clinical and research partners, the University of Washington and Seattle Childrens, is the only National Cancer Institute-designated comprehensive cancer center in the Pacific Northwest.
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 employeeswho bringdifferent and innovativeways of seeing the world and solving problems.Fred Hutch is in pursuit of becoming an antiracist organization.Weare committed to ensuring that all candidates hired share our commitment to diversity,antiracism, and inclusion.
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 Coordinator position will support the HVTN/CoVPNs Leadership Operations Center (LOC) for Regulatory Affairs and other groups as needed by managing the operation of projects and studies. The incumbent works under the direction of the HVTN/CoVPN Associate Director of Regulatory Affairs. Special skills and knowledge are applied in coordinating 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 (SDMC), and Laboratory Center (LC).
Coordinate the regulatory aspects of specimen management, including tracking specimen destruction triggers and completing tasks associated with auxiliary studies.
Through consultation with subject matter experts, register clinical trials to NIHs clinicaltrials.gov website and update existing records in the ClinicalTrials.gov database to reflect protocol changes and site milestones.
Assist sites in obtaining biosafety reviews in instances when a site does not already have an Institutional Biosafety Committee (IBC).
Track sites Institutional Review Board (IRB) and IBC annual continuing reviews and alert sites to upcoming expirations to prevent lapses from occurring.
Work with sites to trouble-shoot the resolution of any lapses in continuing review.
Upload and manage regulatory documents in electronic Trial Master Files (eTMFs).
Coordinate translation and distribution of safety-related documents to sites.
Enter and update HVTN and CoVPN protocols in the Clinical Trials Management System.
Coordinate submissions to the Fred Hutch IRB and commercial IRBs, including assembling submission packages, electronically filing submissions and approvals, and communicating with sites.
Provide support to the annual Financial Disclosure/Conflict of Interest solicitation process
Work with other LOC Project Coordinators/Managers to improve cross-unit processes/systems and implement special projects.
Document operating procedures using SOPs, Work Practice Guidelines, Job Aids, and checklists so others may fill in if needed.
Participate in LOC continuous improvement efforts and ongoing Lean activities as needed.
Perform other tasks as assigned.
BA/BS required plus 3 years of experience in a clinical research setting. Other relevant work experience may substitute.
Sharp critical thinking skills
Excellent written and verbal communication skills
Extremely organized and with a high level of attention to detail
Excellent judgement and interpersonal skills
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 are required.
Basic knowledge of research protocols is preferred
Knowledge of SharePoint, Veeva Vault, and Smartsheet are preferred.
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.
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.