Reference Number: RMS010915
Category: Research, Science and Biotechnology
JOB PURPOSE: To undertake a large multi-centre clinical trial of antimicrobial treatment in sick malnourished children.
REPORTS TO:Principal Investigator
SUPERVISES:Trial coordinator, data manager and trial teams at the study sites
BUDGET AND RESOURCE RESPONSIBILITY:Trial budget, together with the trial coordinator
The KEMRI/University of Oxford/Wellcome Trust Collaborative Research Programme conducts high quality clinical trials focussing on diseases with a high burden for developing countries. The Clinical Trials Facility (CTF) oversees the design, strategy, coordination and governance of high quality phase I, II, III and IV clinical trials across East Africa. The CTF is involved in both investigator-led and externally-led multicentre trials involving drugs, vaccines, nutritional and systems interventions. The CTF aims to maximise opportunities for learning and training in order to maintain a cadre of highly skilled and experienced African trials staff from all disciplines.
The FLACSAM trial will examine the efficacy on mortality of different first-line antibiotic combinations amongst very sick children who are severely malnourished and are admitted to hospital. It is a large clinical trial that will be conducted across several sites, where study teams will be based. The trial will follow up children after discharge. There will be an initial phase of pharmacokinetic studies to determine dosage and ongoing work on the aetiology of infections and antimicrobial resistance.
The post holder will have a very high level of responsibility for the trial, ensuring clinical standards, trial integrity, adherence to regulatory requirements, managing staff and ensuring that the trial runs smoothly. The post holder will need to be self-sufficient and be able to work unsupervised with an unpredictable timescale. The post is mentally demanding, and involves a high level of communication among trial staff, with trial sites, study participants, regulatory bodies and the wider community. The post holder will be expected to publish academic papers. There will be opportunities to develop sub-studies in scientific areas of the post holder’s interest.
• Clinical care and advising on care for study participants and other sick children.
• Participation in the clinical care rota in Kilifi
• Develop clinical trial protocols, CRFs and informed consent documents, and submit them for scientific and ethical approval.
• Develop SOPs for the trial together with the study team, conduct training on clinical SOPs and ensure that clinical teams fulfil their roles and responsibilities.
• Maintaining ongoing responsibility for maintaining clinical standards.
• Line management of site trial clinical staff, including conducting performance reviews.
• Work with the trial coordinator and data manager to create interim reports and presentations.
• Data analysis and writing papers for publication
• Participate within the CTF in scientific and business meetings and assisting in monitoring/planning other trials.
QUALIFICATIONS, SKILLS & COMPETANCIES:
• Medically qualified and registered to practice in Kenya
• MMed in paediatrics or relevant specialty,
• Strong leadership, organisational and planning ability, with an ethical standpoint
• A high standard of written scientific English
• Experience in training or teaching
• Computer literacy in project management tools and Microsoft applications
• Demonstrable interest in pursuing an academic career in acute paediatrics, infectious diseases, clinical immunology, clinical pharmacology or critical care
• Experience in clinical research leading to publication
• Experience in undertaking paediatric clinical trials
• MPH or MSc
• Training in GCP and research ethics
Note: MBChB + MPH/Msc with a strong evidence of extensive skills and experience in clinical trials may be considered for the post.
• Based at the Clinical Trials Facility in Kilifi.
• Regular travel, including travel outside of working hours, within and out of the country to visit trial sites for training, oversight, clinical reviews and trouble shooting.
• Be available to work flexibly, out of hours as necessary.
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All applicants are required to state their current/last salary.
Candidates must supply an email and telephone contact that will be used when offering interviews. Only shortlisted candidates will be contacted. Shortlisted candidates shall be required to produce ORIGINALS of their National Identity Card, academic and professional certificates, original transcripts and testimonials, detailed curriculum vitae and valid clearance certificate (certificate of good conduct) during the interviews.
The application closing date is 15th September, 2015.
KEMRI-Wellcome Trust Research Programme (KWTRP) is an equal opportunity employer. Direct or indirect canvassing will lead to automatic disqualification. KWTRP does not charge a fee at any stage of the recruitment process (application, interview, meeting, processing, training or any other fees).