Key Responsibilities:
Coordinate all issues related to investigational products importations, supply and preparation of all doses for administration/use to/by the study participants.
Maintaining appropriate records of the receipt and disposition of investigational products and inventory of all medicines
Maintain a system to monitor and document storage conditions for investigational products to ensure quality of the products is not compromised
Manage study participant randomization process where applicable and ensure compliance to assigned treatment groups
Maintains the blinding of the participant’s treatment assignment
Maintains the blinding of the participant’s treatment assignment to investigators, study nurses,clinic staff and participant, where required
Maintains the confidentiality of the participant, participant’s pharmacy file and the study drug/placebo accountability record
Establishes a system to ensure that the participants sign an informed consent before dispensing the drugs and the current IRB approved version of the protocol is being followed when dispensing the investigational products.
Prepares pharmacy related standard operating procedures ensuring they meet GCP, NIH and other regulatory requirements.
Vacancy Requirements:
Bachelor’s Degree in Pharmacy Mandatory
Must be Licensed by the Pharmacy and poisons Board of Kenya. Mandatory
At least two years Clinical Research experience. Mandatory
Knowledge of Good Clinical Practice (GCP) and Human Subject Protection (HSP) in research. Mandatory
Good judgment in problem solving, awareness of own limitations and strong internal motivation Mandatory
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