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.
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