Job Description
Working with the Study team to prepare sites for Study implementation.
Supporting sites to maintain Study site files including approvals, protocols and SOPs, registers and tools, and source documents.
Participating in site staff engagement, training, and performance management
Assist site staff in conducting Study procedures including informed consenting, recruitment, clinical service provision, adherence counselling, and documentation of source documents.
Ensuring appropriate eliciting, management, and reporting adverse events including serious adverse events.
Reviewing site performance and working with sites to address implementation challenges
Reviewing Study data and working with site teams to address data queries
Addressing the clinic and laboratory interphase including ensuring appropriate sample collection and shipment, timely results transmission, proper interpretation of results, and working with the laboratory teams to ensure adherence to protocol-defined turn-around times
Ensuring participants' safety and rights are maintained
Ensuring safe and confidential custody of source documents and other study documents
Any other duties assigned by the supervisor
Job Specifications
Diploma in Clinical Medicine and registered to practice with the Clinical Officers Council
Minimum of 3 years' experience with direct clinical care in HIV
Experience in clinical research, participation in clinical trials will be an added advantage
MUST have a current Certificate of Good Clinical Practice
MUST have a current certificate in Human Subject Protection
Excellent written and verbal communication skills
Keen attention to detail
Evidence of intermediate level IT skills
Certification in the National Advanced HIV Clinical Course is an added advantage
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