Regulatory Coordinator, HVTN and CoVPN

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.

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.

Job Summary
The Regulatory Coordinator position will support the HVTN/CoVPN’s 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 Director of Quality & 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.

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 (SDMC), and Laboratory Center (LC)
• Coordinate the regulatory aspects of specimen management, including tracking specimen destruction triggers and completing tasks associated with auxiliary studies
• 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
• Work with protocol team leadership at DAIDS and DAIDS contractors to register clinical trials to NIH’s clinicaltrials.gov website
• 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
• Provide administrative support for submissions to the Fred Hutch IRB and commercial IRBs, including assembling submission packages, electronically filing submissions and approvals, and communicating with sites
• 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
• Actively participate in LOC continuous improvement efforts and ongoing Lean activities
• Perform other tasks as assigned

Qualifications

• BA/BS required plus 2 years of experience in a clinical research setting. MA/MS desired. Other relevant work experience may substitute
• Basic knowledge of research protocols is preferred
• Experience in continuous improvement/Lean methodologies strongly desired
• 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. Knowledge of SharePoint, Veeva Vault, Smartsheet, and Blueworks are preferred.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and anti-racism in your career or that will be made through 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 hrops@fredhutch.org or by calling 206-667-4700.