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  • Posted: Mar 16, 2023
    Deadline: Not specified
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    The KEMRI Wellcome Trust Research Programme (KWTRP) is based within the KEMRI Centre for Geographic Medical Research - (Coast). Our core activities are funded by the Wellcome Trust. We conduct integrated epidemiological, social, laboratory and clinical research in parallel, with results feeding into local and international health policy. Our research platfor...
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    Research Medical Specialist II -HSU

    JOB DIMENSIONS:

    The Job will involve coordination of the WHO-led sentinel surveillance for the RTS, S/AS01 malaria vaccine in 6 hospitals in western Kenya and antimicrobial resistance (AMR) surveillance in several hospitals in Kenya. The AMR surveillance seeks to investigate applicability of the ‘hub’ and ‘spoke’ approach as a surveillance approach and to estimate the burden of AMR in hospitalised children. The post is based in Kenya at the KEMRI-Wellcome Trust Research Programme (KWTRP), Nairobi, but involves extensive interactions with collaborators in the Ministry of Health (MoH), county governments, academic research collaborators, and other scientists in the programme.  Suitable candidates will be highly driven, with string negotiation skills, an effective communication, able to lead teams and strong research publication skills. This is a full-time appointment for a period of 12 months initially, with the possibility of extension

    KEY RESPONSIBILITIES:

    • Coordinate day to day running of the study in consultation with the principal investigator and other team members to ensure that overall execution of studies in line with approved protocol  
    • Work with the Principal Investigator and other relevant staff members to prepare and execute research plans in liaison with other partners in the project
    • Track quality of the surveillance to ensure high quality data
    • Identify data queries and coordinate their resolution
    • Coordinating field and data management teams
    • Conduct trainings for study teams as required
    • Develop research interests and publish manuscripts linked to the study project.
    • Prepare progress reports for submission to funders and sponsors
    • Liaise with MoH, county hospitals and other stakeholders to ensure smooth conduct of the study.
    • Represent the principal investigator at external meetings and present study outputs at scientific meetings

    QUALIFICATIONS:

    • Bachelor of Medicine and Bachelor of Surgery ((MBChB, MBBS or equivalent) degree or its equivalent.
    • and Master of Medicine (M.MED.) degree in any specified field (e.g. Paediatrics, Obstetrics & Gynaecology etc or its equivalent from any recognized university or institution.
    • Current registration Kenya Medical Practitioners and Dentists’ Board
    • Experience working in a biomedical research environment.
    • Competence in use of R, STATA or other software applications to undertake statistical analyses is an added advantage.
    • Knowledge of Good Clinical Practice (GCP) training and Human subject Protection.
    • Experience in writing reports or publication of master’s dissertation is an added advantage.

    COMPETENCIES:

    • Strong interpersonal and communication skills
    • Excellent scientific writing skills and presentation skills (use of PowerPoint or other media)
    • Ability to work with limited supervision and meet deadlines
    • Excellent diagnostic, analytical and investigative skills
    • Strong leadership skills
    • Ability to work independently, in a team, and in a multi-cultural environment
    • Confidentiality, attention to detail, punctuality, and high integrity

    PHYSICAL ENVIRONMENT/CONDITIONS:

    • Based at the Nairobi office of KEMRI/ Wellcome Trust Research Programme, Kenya
    • Travels as required to study sites and other study related meetings.

    The application closing date is 29 March, 2023

    go to method of application »

    Project Manager - Interventional Projects

    JOB PURPOSE: 

    To plan, develop, implement and coordinate operational and administrative aspects of BOHEMIA clinical trial.

    Job Dimensions:

    The post holder will be responsible for planning, developing, implementing and coordinating operational and administrative aspects of the BOHEMIA project as well as support the principal investigator in research coordination, preparation, and maintenance of various scientific and research governance-related materials for the purposes of ethical and regulatory approval, GCP, and monitoring requirements.. The post is extremely demanding and involves a high level of diplomacy with regards to effective communication among a multi-disciplinary team, study participants, departmental managers, regulatory bodies and the wider community. The post holder will need to be experienced and highly self-sufficient to manage a complex programme of research work.

    This post is based at the KWTRP with frequent travel to Kwale. KWTRP is a partnership between the Kenya Medical Research Institute, the Wellcome Trust and the University of Oxford, and a world-renowned health research unit. The KWTRP works together with scientists, health services and local communities to achieve better health, while also developing local scientific leadership and infrastructure.

    Reports to:

    • Head of Clinical Trials Facility/Principal Investigator

    Direct Reports: 

    • Data Manager
    • Research Medical Officer
    • Pharmacist, Archivist

    Financial Responsibility: 

    • The position is responsible for oversight of research grant budget and project assets

    Key Responsibilities:

    • Ensure effective project plans are in place and operational for each work package and work proactively with the team to set priorities in accordance with applicable project plans, standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements; and maintain a register of risks and implement strategies to mitigate risk in collaboration with the QA manager.
    • Establish systems to track trial progress, milestones and performance metrics.
    • Provide efficient updates on trial progress to the PI, with respect to project plans, trial budget and timeline management, recruitment, inventory management, and trial conduct.
    • Oversee organizational structures, work schedules, task management and project milestones; be responsible for analysis, monitoring and evaluations of targets and strategic objectives; identify potential delays, bottlenecks and their effects on project deliverables; and implement strategies to ensure operational effectiveness.
    • Lead study planning and start-up process, including but not limited to conduct of the Trial Kick-off meeting, the set-up of trial master file (TMF) and study planning meetings.
    • Contribute to strategic planning and oversight of capital, operating budgets and expenditures for research grants and future grant applications in liaison with the finance and grants departments at KWTRP and the University of Oxford.
    • Responsibility for ethics and regulatory document preparation and submissions, timely report submissions and communication with ethics and regulatory bodies.
    • Develop or supervise development of Standard Operating Procedures (SOPs) for the projects together with the study team and conduct training/supervise training on SOPs/SIVs and ensure that clinical teams fulfil their roles and responsibilities.
    • Responsibility for maintenance of study records and documents, their secure storage, and ensuring all data are filled out appropriately and documents are up to date.
    • Coordinate monitoring and audit visits and ensure that all requirements are met including availability of documentation and relevant staff.
    • Liaise with the KWTRP Community Liaison Group to develop and implement site and community engagement strategies.
    • Represent the research project to relevant internal committees, external organizations and, where appropriate, funding agencies.
    • Participate in scientific and business meetings within the Clinical Trials Facility when required.
    • Undertake other duties as assigned.

    Qualifications:

    • A Masters in life sciences or equivalent from an accredited institution.
    • A degree in nursing or life sciences, diploma in clinical medicine, or a Registered Nurse
    • At least 5 years’ experience in clinical trials, including 3 years’ experience that is directly related to the duties and responsibilities specified above.

    Essential competencies:

    • Exceptional project management skills, proficiency in using project management tools and the ability to manage multiple large projects simultaneously.
    • Significant skill in leadership, organization, prioritisation, problem solving and decision making.
    • Financially literate with sound knowledge of budgeting methodologies and resource management concepts including proven experience of preparing and monitoring budgets and financial reports
    • Demonstrable experience in writing high quality reports and presentations in English, with evidence of being attentive to detail.
    • Ability to network, communicate, be diplomatic and maintain strong local and international relationships within a multi-cultural environment and wide diversity of people, and have experience in resolving disputes.
    • Knowledge of regulatory requirements and best practices in clinical trials
    • Strong leadership, organisational and planning ability, with an ethical standpoint
    • Strong interpersonal and communication skills (oral and written)
    • Training in GCP and research ethics

    Desirable:

    • Training in Project Management or equivalent from an accredited institution

    Physical Environment/Conditions:

    • Based at the KEMRI-Wellcome Trust Research Programme in Kenya.
    • Some travel to study sites.
    • Be available to work out of hours if necessary.

    The application closing date is 30 March, 2023

    Method of Application

    Use the link(s) below to apply on company website.

     

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