• Regional Medical Liaison, South Africa

    Job ID
    10747
    Type
    Regular Full-Time
    Company
    Hutchinson Centre Research Institute of South Africa
    Location
    ZA-Soweto
    Category
    Clinical Research Support Services
  • 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 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 Regional Medical Liaison plays a key role in providing clinical support for clinical research sites (CRSs) implementing HIV vaccine & prevention trials of the HVTN in Southern Africa. The position is based in Southern Africa and is part of the Clinical Development Unit, Core Operations Center of the NIH-funded HIV Vaccine Trials Network. The Regional Medical Liaison is a resource for CRS staff and other Core Operations 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 the HVTN Leadership.  The main responsibilities of the position are to be involved in the safety monitoring of HVTN trials being conducted in the region.

    Responsibilities

    • Provide training to CRSs and respond to CRS queries on clinical matters related to HVTN HIV vaccine trials, including but not limited to clinical data collection, and optimal assessment, management, and reporting of adverse events.
    • Conduct active monitoring and review of safety data from all phases of HIV vaccine clinical trials; this may include serving on the Protocol Safety Review Teams (PSRTs) for clinical trials.
    • Contribute to the development of clinical case report forms (CRFs), Study-specific Procedure documents (SSPs), and other protocol documents
    • 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.
    • Contribute to the preparation, review, and distribution of safety reports for the PSRT and for the Safety Monitoring Board (SMB) and Data & Safety Monitoring Board (DSMB).
    • Provide ongoing consultation on protocol clinical safety issues to protocol teams and to CRS and HVTN Core staff.
    • Provide on-call coverage of HVTN 24/7 Safety Phone.
    • As needed and working in close collaboration with other HVTN staff, participate in teams that support the development and implementation of HVTN trial sites and HVTN clinical trials in Southern Africa; this may include contributing to the design of clinical monitoring plans.
    • As needed and working in close collaboration with other HVTN regional staff, contribute to the evaluation of site plans for implementation of the clinical trial, including contributing to assessments of clinical and clinical data management procedures during clinical trial implementation.
    • Rotations in clinical trial sites involved in HVTN trials, including involvement in enrolling and following  trial participants and site QA/QC, regulatory, and related processes.
    • Other duties as assigned.

    Qualifications

    Education and training:  

    • A physician (MBChB, MBBS, MD or equivalent degree) with clinical experience in Southern Africa is strongly preferred.
    • 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.

     

    Skills:

    • The ideal candidate should have exceptional written and verbal communication skills, including but not limited to excellent email and teleconference skills.
    • Should demonstrate the ability to identify, communicate, and follow up on clinical trial conduct and clinical data issues with study sites and research collaborators.
    • should be highly organized; should have experience and facility working with individuals with a wide range of education and experience.
    • Should be able to handle challenging workloads and multiple concurrent projects.
    • Should be proficient with standard business productivity software, including word processing and spreadsheets.
    • This position will require collaboration with colleagues based globally and, as such, will require work outside of normal South African business hours, approximately 30% regional travel, and approximately 2-4 weeks per year in the US.

    Our Commitment to Diversity

    We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We are proud to be an Equal Opportunity and VEVRAA Employer. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability, marital or veteran status, 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 escmail@fredhutch.org or by calling 206-667-4700.

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