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.
The Regional Medical Liaison plays a key role in providing clinical support for clinical research sites (CRSs) implementing vaccine & prevention trials of the HVTN/CoVPN in Southern Africa. The position is based in Southern Africa and is part of the Clinical Development Unit, Leadership Operations Center (LOC) of the HVTN/CoVPN and reports to the Programme Lead/Protocol Team Lead. The Regional Medical Liaison is a resource for CRS staff and other LOC staff based in Southern Africa and is a liaison between Southern Africa-based clinical CRS staff, Seattle-based Clinical Safety Specialists and Clinical Trials Physicians, and Network Leadership. The main responsibilities of the position are to be involved in the safety monitoring of trials being conducted in the region.
Responsibilities:
Project Management, coordination, support and implementation (20%)
- Provide on-call coverage of HVTN 24/7 Safety Phone
- As needed and working in close collaboration with other Network staff, participate in teams that support the development and implementation of trial sites and clinical trials in Southern Africa; this may include contributing to the design of clinical monitoring plans
- Other duties and assignments as requested for the overall performance of the department and company
- Serve as the primary contact for medical related queries
Safety Management, Quality control, Quality Assessment Coordination (50%)
- Conduct active monitoring and review of safety data from all phases of vaccine clinical trials; this may include serving on the Protocol Safety Review Teams (PSRTs) for clinical trials
- Help ensure completeness, accuracy, and safety compliance of clinical data provided by CRSs, including querying sites for clarification and updates as needed during the conduct of the trial
- Provide ongoing consultation on protocol clinical safety issues to protocol teams and to CRS and Network staff
- Contribute to the preparation, review, and distribution of safety reports for the PSRT
- Contribute to the preparation of reports for the Safety Monitoring Board (SMB) and Data & Safety Monitoring Board (DSMB) if applicable
Clinical Research Support, quality assurance, protocol adherence (20%)
- Provide training to CRSs and respond to CRS queries on clinical matters related to the Network’s vaccine trials, including but not limited to clinical data collection, and optimal assessment, management, and reporting of adverse events
- Contribute to the development of clinical case report forms (CRFs), Study-specific Procedure documents (SSPs), and other protocol documents
- As needed and working in close collaboration with other Network staff, participate in teams that support the development and implementation of the Network’s trial sites and clinical trials in Southern Africa; this may include contributing to the design of clinical monitoring plans
Other duties as assigned (10%)
Qualifications:
EDUCATION, CERTIFICATION, QUALIFICATIONS AND EXPERIENCE NEEDED
- A medical doctor (MBChB, MBBS, MD or equivalent degree) with clinical experience in Southern Africa is strongly preferred
- Postgraduate education in public health or clinical research or administration
- Preference will be given to those applicants with experience in public health or a research field and to those with data management experience in international research
- Candidate should possess familiarity with clinical trials safety data collection practices, clinical data and adverse event reporting, and regulatory requirements
COMPETENCIES / JOB SPECIFICATIONS REQUIRED TO DO THE JOB
- Meticulous attention to detail
- Good numeracy, literacy and organizational skills
- Ability to follow lab protocols and Standard Operating Procedures
- Clinical Research Expertise
- Good communication skills and an interest in learning
- Good interpersonal and time management skills and ability to work in a team
- Willingness to be flexible in working hours, including working evenings and weekends as needed
- Should demonstrate the ability to identify, communicate, and follow up on clinical trial conduct and clinical data issues with study sites and research collaborators
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 [email protected] or by calling 206-667-4700.