Reference Number: CO07-16
Category: Clinical Healthcare and Research
This role will involve the day to day running of research studies in undernutrition that includes a cohort study i.e. CHAIN study, as well as a randomized trial of antibiotics in children with severe acute malnutrition (FLACSAM trial). The post holder conducts daily activities to ensure communication with participants, clinical assessment and care, timely recruitment, data collection, follow up and adherence to study-specific procedures in the malnutrition research projects. CHAIN study is a large multi-site cohort study under Childhood Acute Illness and Nutrition Network (CHAIN Network) that aims to build the evidence-base for the care of sick and undernourished children in resource-limited settings. CHAIN Network brings together clinicians and scientists from a wide variety of high disease-burden settings in Africa and South Asia, to create a set of systematically collected data and samples harmonized between sites that are generalizable, optimal for pooled analyses, and allow for comparisons between and across sites. To meet this goal, the CHAIN Network is conducting studies to identify clinical, social and behavioral characteristics of children at risk of death during and after hospitalization. The First Line Antimicrobials in Severe Acute Malnutrition (FLACSAM) trial will examine the efficacy 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, including Mbagathi hospital, where study teams will be based. The post holder will have a high level of responsibility for ensuring study integrity, adherence to guidelines and standard operation procedures, managing staff and ensuring that the studies runs smoothly. The post holder will need to be self-sufficient and be able to work unsupervised, often with an unpredictable timescale. The post is mentally demanding, and involves a high level of communication among study team, with other participating study sites, study participants and the wider community. Staff operating at this grade range contribute to a research team and deal with non-standard work situations more regularly than staff at lower grades and take decisions often relating to the interpretation of standard operating procedures. They are required to provide guidance to team members at lower grades, and also be involved in supervising the work of others. Staff have responsibility for prioritising their own work and ensuring the necessary equipment/materials are available.
REPORTING LINES: The postholder will report to the Senior Clinical Officer
- Assist with clinical paediatric care particularly in children admitted with malnutrition.
- Screen and identify potentially eligible participants among paediatric admissions for inclusion into studies at the site.
- 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.
- Monitor treatment toxicity/side effects and liaise with the clinical care team to initiate changes to treatment as required by the protocol.
- Ensure that the whole team are working according to GCP and research governance standards for clinical trials.
- 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
- Be required to undertake other duties, which are broadly in line with the above key roles and responsibilities.
SKILLS AND COMPETENCE:
- Diploma in Clinical Medicine
- At least 2 years’ experience in paediatric care
- Prior evident work experience in clinical research studies
- Flexible – able to work extra hours when needed
- Able work under stressful environment, self-driven and highly motivated
- Strong interpersonal and communication skills (oral and written)
- Personnel management skills and computer-literate with proficiency in project management tools and Microsoft applications
- Experience in clinical trials/research work, can apply GCP standards
- Experience of care for sick, malnourished children