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  • Posted: Aug 3, 2022
    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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    Clinical Trial Coordinator - VIRUTUBISHO Trial

    JOB PURPOSE: 

    To plan, implement and coordinate clinical research operations in the maternal and child nutrition research group at KWTRP Kilifi/Coast. The post holder will be responsible for managing a community based clinical trial of multiple micronutrient supplementation to women of reproductive age (non-pregnant & pregnant) in Kilifi county (VIRUTUBISHO Trial). The post holder needs to be experienced in leading research teams and be highly self-sufficient to manage complex clinical trial research work. The post is mentally demanding, involving attention to detail and timescales, and strong engagement with stakeholders.  

    JOB DIMENSIONS:

    The KEMRI-Wellcome Trust Research Programme (KWTRP) is a world-renowned research institution in Kenya that conducts studies of public health interest. One area of great public health interest is research in maternal and child nutrition that aims at improving health amongst vulnerable women of reproductive age (WRA) in developing countries.  The group is focussed on Management of nutritional At-risk mothers and infants under 6 months of age (MAMI). We have been evaluating contribution of maternal nutrition, and maternal risk factors in poor infant outcomes. We have applied mixed method approach to evaluate breast feeding problems in 1st month of life, hospital-based studies on infants with severe wasting in first 6 months of life to improve breast feeding support in and out of hospital (IBAMI1 & 2). We are members of NeoNunet; a collaborative network of Nigerian and Kenyan newborn units set up to evaluate evidence for feeding of premature and low-birthweight neonate.

    The VIRUTUBISHO Trial aims to optimize nutrient requirement for maternal supplementation. It is a Phase 2b dose-finding pharmacokinetic trial of Balanced Energy Protein (BEP) and Multiple Micronutrient Supplements (MMS). It is a community-based trial that will recruit women of reproductive age from two locations in Kilifi north sub-county.

    The post holder will be based in Kilifi to promote effective management of the trial and participate in other group activities. They will work with an experienced team of clinical trial co-ordinators in the larger nutrition research group i.e. CHAIN Network(https://chainnetwork.org/). 

    KEY RESPONSIBILITIES:

     Administrative oversight

    • Overall coordinator of the VIRUTUBISHO trial to oversee administrative aspects of staffing, project budgeting, procurement and accountability, security, health and safety
    • To manage/oversee a team of clinical and field staff working in the VIRUTUBISHO trial
    • To undertake/guide risk assessment of study together with study investigator, to maintain a register of the risks, and to participate in developing risk mitigation measures drawing from administrative support in KWTRP in accordance to applicable policies and guidelines
    • To lead/guide resolution of operational challenges/problems affecting study team
    • Participate in writing of project gantt charts, implementation timelines, and identification of milestones and to use this to regularly monitor overall project progress.

    Study coordination

    To manage the day-to-day implementation of the VIRUTUBISHO trial.

    • Coordinate process of ethics and scientific applications and renewals for the study protocol, and trial registration.
    • Manage development of training plans for the research protocol, as well as overall staff recruitment, development trainings and mentorship.  
    • Collaborate with the scientific leads on preparation of SOPs, data collection tools (CRFs/Source documents), quality manuals and processes in line with institutional guidelines and international research standards (GCP)
    • Responsible for intervention delivery using direct observed treatment (DOTs) to provide multiple micronutrient supplement (MMS) to trial participating women of reproductive age in Kilifi.
    • Responsible for participants sampling, quality, completeness and transport of samples from field sites to KWTRP laboratories for processing and storage
    • Responsible for data collection, reviewing of data quality and completeness on site, and communication with clinical and field teams over query resolutions
    • Participate in operations and scientific committees and stakeholder forums at local and international level such as the clinical trials facility monthly meetings.  
    • Coordinate stakeholders’ engagement the VIRUTUBISHO study and to maintain register of completed meetings and planned updates.
    • Facilitate monitoring of the clinical and field documentation, review progress and apply monitoring recommendations that might include additional trainings.

    QUALIFICATIONS:

    Essential:

    • Degree in Public Health/Epidemiology/Clinical Trials or related fields
    • At least 3 years’ experience in coordinating a clinical trial including setting up a trial and working with trial monitors.
    • Competency in computing skills the use of excel sheets, Ms word and power point
    • Exceptional project management skills, proficiency in using project management tools and the ability to manage an intensive clinical trial.
    • Demonstrable experience in writing high quality reports and presentations in English, with evidence of being attentive to detail.
    • Ability to network, communicate, resolving disputes and maintain good working relationships within a multi-cultural environment.

    Desirable:

    • Community mobilization for a community-based trial
    • Familiarity with local setting, culture and language is an added advantage

    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.

    The application closing date is 16 August, 2022.

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