Vacancies at The Kenya Medical Research Institute (KEMRI)

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

Key Responsibilities:

• Administer respective Case Report Forms (CRFs)
• Carrying out QA/QC of study CRFs and source docs and resolve queries that may arise.
• Dispensing drugs and Study products to participants.
• Ensure prescription drugs are available for dispensing to participants
• Maintaining pharmacy temperature and humidity logs
• Develop and review of pharmacy SOPs and ensuring adherence to the same
• Counselling participants on adherence to study products
• Participants Randomization process in liaison with the data and clinic teams.
• Maintain the pharmacy database and keeping it up to date.
• Ensuring accurate and timely records of dispensed drugs and study products on the pharmacy logs and in the accountability logs and Database.
• Processing shipment documentation of study products and track study product shipment from source to site.
• Processing study products destruction documents and taking part in actual destruction process.
• Enhancing communication between pharmacy and local PPB and coordinating Center.
• Management of regulatory affairs regarding pharmacy and the study.

Vacancy Requirements:

• Diploma in Pharmaceutical Technology    Mandatory
• Registered with the Pharmacy and Poisons Board    Mandatory
• Good Clinical Practice or Human Subjects Protection training will be an added advantage    Added Advantage
• Commitment to integrity and high-quality performance    Mandatory
• Good interpersonal skills and ability to work in a team    Mandatory
• Keen and attentive to detail    Mandatory
• Good communication skills    Mandatory
• Counselling skills    Mandatory
• Computer literacy    Mandatory

Key Responsibilities:

• Performing Clinical Assessments.
• Collecting specimens.
• Conducting interviews, administering Case report forms, and form completion
• Offer support counselling to study participants.
• Conducting the informed consent process.
• Diagnose and provide STI and treatment for other ailments to participants.
• Make requisitions for the required clinical supplies.
• Monitor Adverse events and write reports to IRB or any other regulatory body as required
• Develop and implement Standard Operating Procedures as per protocol
• Perform any other duties as assigned by immediate supervisor.
• Safety communication with the medical director, study safety monitor, and Principal Investigator

Vacancy Requirements:

• Bachelor’s Degree in Medicine and Surgery (MBChB)    Mandatory
• Minimum 3 years’ professional clinical experience    Mandatory
• Professional experience in emergency/disaster medicine, outbreak management, public health,pediatrics, rural and remote medicine or other relevant areas is an asset    Mandatory
• More than one (1) year Clinical research experience    Mandatory
• Good Clinical Practice training/Human Subjects Protection training    Mandatory
• Up to date with resuscitation and anaphylaxis including competent to give intramuscular injections and subcutaneous administration of local anesthetic    Mandatory
• Experience working with pediatric, adult and geriatric patient populations    Mandatory
• Ability to coordinate and deliver out-patient services in low-resource settings    Mandatory
• Commitment to integrity and high-quality performance    Mandatory
• Good interpersonal skills and ability to work in a team    Mandatory
• Keen and attentive to detail    Mandatory
• Good communication skills    Added Advantage
• Counselling skills    Added Advantage
• Computer literacy    Added Advantage