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. The HVTN conducts all phases of clinical trials, from evaluating experimental vaccines for safety and immunogenicity to testing vaccine efficacy.
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 networks to address the pressing need for vaccines and monoclonal antibodies (mAbs) against SARS-CoV-2.
The Clinical Trials Manager is primarily responsible for ensuring the efficient and effective implementation of HIV and COVID-19 vaccine and monoclonal antibody research protocols, from protocol development through long-term follow-up. This position is also responsible for development of new clinical research sites, ensuring that the site can conduct rigorous clinical trials. This includes effective project management, communicating effectively with diverse stakeholders, production of training, and study specific procedure materials, developing and driving timelines and adjusting expectations as necessary. Position requires travel to study sites for on-site training or assessment.
Please include a cover letter describing your interest and qualifications for this position
The incumbent reports to the Associate Director of Site Operations at the HVTN/CoVPN Core Operations Center. Special skills, knowledge and judgment are applied in independently managing site-level project/study operations, in developing methods and materials, and in carrying-out complex multi-site research management responsibilities. The Clinical Trials Manager, soliciting assistance from other stakeholders and informing the Associate Director of Site Operations as appropriate, handles problems and challenges that arise in the implementation of projects/studies. Position is based in the Seattle area but will require collaboration with colleagues globally and includes approximately 15% travel, when travel is permitted by Fred Hutch (currently n/a due to COVID-19 pandemic).
Perform some or all of the following responsibilities:
- Ensure efficient protocol start-up & implementation at study sites by facilitating or liaising between sites, other functional units within the HVTN/CoVPN, the developer, the sponsor, and others as needed. Manage expectations for Core, HVTN/CoVPN Leadership and sites related to study implementation, including the start-up timeline, enrollment, and site performance.
- Along with the Protocol Team Leader, represent the protocol team in developing, reviewing, and/or revising research materials including Study Specific Procedures, SOPs, questionnaires, Case Report Forms/data collection instruments, educational materials, and recruitment materials. Develop/contribute to content of data collection instruments, as negotiated with the data management center and protocol team, on a protocol-by-protocol basis.
- Prepare protocol-specific training and study materials for study site use. Develop, interpret, and administer project/study policies and procedures according to protocol, IRB, grants/contracts, data management center, laboratory program and Fred Hutchinson Cancer Research Center specifications.
- Set project goals and drive implementation timelines to ensure that all implementation activities are completed on time. Ensure clear internal cross-unit collaboration and communication, including identification of milestones, issues & resolutions.
- Coordinate development of new sites. Assess capacity of study sites to conduct research protocols in accordance with network SOPs, DAIDS requirements, and principles of Good Clinical Practice.
- Coordinate site space and equipment planning and utilization, evaluate current project/study needs, anticipate future needs, and oversee acquisition of space/equipment.
- Represent and advocate for sites in strategic & operational discussions. Serve as the primary point-of-contact for site knowledge and site-related queries.
- Drawing on knowledge and relationships with sites’ operations, provide input to protocol teams on site expertise and potential obstacles and challenges. Develop site-specific timelines and provide updates on protocol implementation such as enrollment, study product administration, and retention.
- Serve as project/study liaison, representing the project/study to other functional units within the HVTN/CoVPN, and outside stakeholders. Serve as the first point of contact when problems pertaining to a particular protocol and/or site arise. Develop plans for addressing deficiencies at study sites in collaboration with protocol team and DAIDS.
- Plan and attend committee meetings, monitor activities to ensure objectives have been met within designated time frame, and coordinate follow-up activities.
- Other duties as assigned.
- BA/BS in related field required; MA/MS/MPH desired.
- Minimum of three years post Master’s or five years post-bachelor’s related project/study management experience in a research setting.
- Experience with conduct of NIAID-sponsored HIV prevention or vaccine trials desirable.
- Excellent written and verbal communication skills, flexibility and a sense of humor are essential.