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  • Posted: Oct 27, 2021
    Deadline: Nov 10, 2021
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  • Kenya Medical Research Institute (KEMRI) is a State Corporation established through the Science and Technology (Amendment) Act of 1979, which has since been amended to Science, Technology and Innovation Act 2013. The 1979 Act established KEMRI as a National body responsible for carrying out health research in Kenya.
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    Clinical Officer -Mbagathi Site

    KEY RESPONSIBILITIES:

    • Provide clinical care as applicable at the hospital.  
    • Screen and identify potentially eligible participants for the various studies taking place in Mbagathi.
    • Provide information, education and support to families or guardians of potentially eligible research subjects.
    • Administer or oversee the informed consent process.
    • Conduct trial-related assessments and collection of data using case record forms in accordance to Good Clinical Practice (GCP).
    • Assist with documentation and reporting of serious adverse events and clinical endpoints, including death and readmission to hospital for study participants
    • Help to manage study-specific fieldworkers including planning of field activities.
    • Foster good working relations with hospital’s clinical team and be able to contribute to/participate in continuous medical education (CME) activities in paediatric department
    • Obtain demographic information and detailed medical history, comorbidities, drug allergies etc,
    • Collection of trial specific blood samples including nasopharyngeal swabs, blood, and sputum samples according to the laid-out SOPs.
    • Track and report participants missed doses.
    • Prescribe investigational products and other pharmaceutical drugs. Monthly review of participants to assess drug tolerability and other symptoms and fever.
    • Record reasons for participants withdrawal from studies.
    • Conduct quality checks for CRFs and other trial related documents
    • Record of protocol deviations, maintaining of file notes, documenting lost to follow-ups.
    • Be required to undertake other duties, which are broadly in line with the above key roles and responsibilities.

    SKILLS AND COMPETENCE:

    Essential:

    • Diploma in Clinical Medicine
    • At least 3 years’ experience in paediatric care
    • Prior evident work experience in clinical research studies/ clinical trials and can apply GCP standards
    • Flexible – able to work extra hours when needed
    • Able to work under stressful environment, self-driven and highly motivated
    • Strong interpersonal and communication skills (oral and written)

    Desirable:

    • Experience of care for sick malnourished children
    • Personnel management skills and computer-literate with proficiency in project management tools and Microsoft applications

    PHYSICAL ENVIRONMENT/CONDITIONS:

    • Based at the Mbagathi Hospital, Nairobi.
    • Be available to work flexibly, out of hours as necessary.
    • Travel to other trial sites for covering leave and for training.
    • Exposure to patients and materials considered infectious and/or biohazards.

    go to method of application »

    Lead Monitor

    JOB PURPOSE: 

    This role is responsible for monitoring and providing oversight within the clinical trials facility as well as specific monitoring responsibilities for allocated studies. This position provides oversight for monitoring activities at the Programme as well as monitoring of clinical studies conducted by internal researchers or affiliates in other institutions. 

    Description: 

    REPORTS TO:  

    • Research Governance manager  

    DIRECT REPORTS: 

    • Study Monitors  

    FINANCIAL RESPONSIBILITY: 

    • Manage CTF Monitor’s budget 
    • Develops Monitor’s budgets  

    KEY RESPONSIBILITIES:

    • Manage and implement monitoring activities and schedules across the Programme. 
    • Lead the development of monitoring strategies, budgets, guidelines, procedures, and tools. 
    • Review monitoring plans and reports resolve issues and establish quality assurance. 
    • Manage monitoring records and ensure safe keeping and ease of reference. 
    • Conduct training needs and competency needs assessment for monitoring team. 
    • Coach and mentor study monitors and additionally organise/facilitate refresher/relevant training opportunities. 
    • Assess monitoring needs for study protocols and develop study specific monitoring plans. 
    • Conduct variety of monitoring visits as per monitoring plan including site assessment, site initiation, routine visits (onsite, remote, central) & close out visits. 
    • Verify protocol and regulatory compliance for each study.  
    • Review all laboratory procedures performed regarding samples, equipment and documentation. 
    • Review all pharmacy procedures performed regarding supplies, shipping and dispensing records, product accountability, adequate supply and replacement and blinding and randomization processes.  
    • Verify the site is collecting accurate and credible data (ALCOA); and 
    • Assess study and site management verifying activities are properly documented and complete and accurate records. 

    QUALIFICATIONS:

    ESSENTIAL:

    • Bachelor’s degree in sciences (Biological, Nursing) in a relevant field; Masters is an added advantage. 
    • Minimum 5 Years with 3 Years’ experience at Supervisory level 

    DESIRED: 

    • Accreditation as a Clinical Research Associate or similar certification 
    • Demonstrate a working knowledge of GCP guidelines; 

    COMPETENCIES:

    • Demonstrate high levels of integrity and confidentiality 
    • Excellent interpersonal, written, presentation and communication skills 
    • Good analytical, problem solving and critical thinking skills. 
    • Teamwork and ability to work with diverse teams 
    • Strong Flexibility, adaptability, multi-tasking and attention to detail 
    • Strong team coordination and Supervisory skills.

    Method of Application

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

     

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