Clinical Safety Specialist, HVTN

Job ID
21280
Type
Regular Full-Time
Company
Fred Hutchinson Cancer Research Center
Location
US-WA-Seattle
Category
Nursing and Nursing Support

Overview

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 Center’s 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 Children’s, 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 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 Clinical Safety Specialist (CSS) is based in Seattle at the HVTN Leadership Operations Center (LOC) of the HVTN and reports to the Manager of Clinical Safety. The CSS functions as a clinical safety data monitor on phase 1-3 HVTN clinical trials, monitoring the clinical data for completeness, accuracy, and for protocol and regulatory compliance. In addition, the CSS serves as a subject matter expert to HVTN staff and collaborators on clinical data monitoring. The CSS functions with supervisory support, as needed, with demonstrated decision-making ability ensuring that the protocol requirements and clinical data safety needs are satisfactorily met.

Responsibilities

Perform some or all the following responsibilities:

  • Function as an active member of Protocol Safety Review Team (PSRT) data reviews, including preparing, reviewing, and distributing PSRT safety reports and PSRT call minutes.
  • Provide ongoing consultation on protocol safety issues to protocol teams, HVTN LOC and Statistical Data Management Center (SDMC) staff, and other collaborators.
  • Participate in protocol development activities, including working with other protocol team members to develop clinical trial safety monitoring and reporting strategies and tools, including clinical report forms (CRFs) and the trial database.
  • Work with HVTN PSRT members and collaborators to ensure appropriate clinical safety report design and accuracy.
  • Monitor and work with sites, including providing training, to ensure clinical data completeness, accuracy, and alignment with regulatory reporting requirements.
  • Write quarterly clinical safety narratives with Medical Monitor (Protocol Team Lead) for Safety Monitoring Board (SMB) reviews.
  • Provide on-call coverage of HVTN 24/7 Safety Phone with other HVTN clinical staff on a rotating basis.
  • Reconcile Adverse Event (AE) data in the clinical database and Serious Adverse Event (SAE)/AE data in the safety database, work with collaborators to resolve discrepancies, and complete data reconciliation reporting requirements.
  • Conduct clinical trial clinical data closeout activities.
  • With other Clinical Safety Unit staff and Medical Monitor staff, provide oversight and guidance on clinical data monitoring issues to other HVTN staff and external partners.
  • Conduct all job duties according to appropriate Standard Operating Procedures (SOPs) and within the context of Good Clinical Practice (GCP) guidelines.
  • Other duties as assigned.

Qualifications

EDUCATION AND TRAINING:

  • Associate degree in nursing (AND) required, Bachelor of Science in Nursing (BSN) preferred.
  • Active RN license (or an equivalent nursing/medical license) required.
  • Familiarity with clinical trials, safety data collection practices, clinical data and adverse event reporting, and regulatory requirements strongly preferred.
  • Experience working with individuals with a wide range of education and experience.

SKILLS:

  • Must have demonstrated ability to work independently and take initiative in a dynamic environment.
  • Demonstrated ability to identify, communicate, and follow up on clinical data issues with study sites and research collaborators.
  • Able to handle challenging workloads and multiple concurrent projects.
  • Position requires a high level of attention to detail and organization.
  • Excellent written and verbal communication skills.
  • High level knowledge of Microsoft applications, specifically Word, Excel, Outlook, Teams, PowerPoint are required. Knowledge of SharePoint and Adobe is preferred.
  • This position is based in the Seattle, but will require collaboration with colleagues globally and includes approximately 15% travel.

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.

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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