Clinical Safety Specialist, HVTN - Fred Hutchinson Cancer Research Center
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 with minimal side effects. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation’s first and largest 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 an international collaboration of scientists and educators searching for an effective and safe HIV vaccine. The HVTN’s mission is to fully characterize the safety, immunogenicity, and efficacy of HIV vaccine candidates with the goal of developing a safe, effective vaccine as rapidly as possible for prevention of HIV infections globally. Our organization conducts all phases of clinical trials, from evaluating experimental vaccines for safety and the ability to stimulate immune responses, to testing vaccine efficacy.
The Clinical Safety Specialist (CSS) is based in Seattle at the HVTN Leadership Operations Center 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.
Perform some or all the following responsibilities:
1. Function as an active member of PSRTs and facilitate Protocol Safety Review Team (PSRT) data reviews, including preparing, reviewing, and distributing PSRT safety reports and PSRT call minutes.
2. Provide ongoing consultation on protocol safety issues to protocol teams, HVTN Core and SDMC staff, and other collaborators.
3. 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.
4. Work with HVTN PSRT members and collaborators to ensure appropriate clinical safety report design and accuracy.
5. Monitor and work with sites, including providing training, to ensure clinical data completeness, accuracy, and alignment with regulatory reporting requirements.
6. Write quarterly clinical safety narratives with protocol Core Medical Monitor for Safety Monitoring Board (SMB) reviews.
7. Provide on-call coverage of HVTN 24/7 Safety Phone with other HVTN clinical staff.
8. Reconcile AE data in the clinical database and SAE/EAE data in the safety database, work with collaborators to resolve discrepancies, and complete data reconciliation reporting requirements.
9. Conduct clinical trial clinical data closeout activities.
10. With other Clinical Safety Unit staff and Core Medical Monitor staff, provide oversight and guidance on clinical data monitoring issues to other HVTN staff and external partners.
11. Conduct all job duties according to appropriate Standard Operating Procedures (SOPs) and within the context of Good Clinical Practice (GCP) guidelines.
12. Other duties as assigned.
Education and training:
• Active RN license (or an equivalent nursing/medical license) and clinical trial experience required.
• Familiarity with clinical trials safety data collection practices, clinical data and adverse event reporting, and regulatory requirements strongly preferred.
• Experience and facility working with individuals with a wide range of education and experience.
• 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, and Outlook are required. Knowledge of SharePoint is preferred.
• This position is based in the Seattle, but will require collaboration with colleagues globally and includes approximately 15% travel.
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