Background information about the job or company (e.g., role context, company overview)

The Kenya Medical Research Institute (KEMRI) is a state corporation established through the Science and Technology (Amendment) Act of 1979, which has since been amended to Science, Technology and Innovation Act 2013 as the national body responsible for carrying out health research in Kenya.KEMRI has grown from its humble beginning over 40 years ago to become a regional leader in human health research. The Institute currently ranks as one of the leading Centres of excellence in health research both in Africa as well as globally.

Responsibilities or duties

Coordinate and supervise field collection teams and overall field operations.

Oversee study activities including chart preparation, scheduling protocol-specific procedures, consent administration, SOPs, and training of clinical staff.

Support the PI in informed consent administration in compliance with study protocols, local regulations, and GCP guidelines.

Ensure accurate data collection, workflow adherence, data capture in eCRFs/CRFs, and resolution of data discrepancies.

Monitor study compliance with protocols and GCP; audit study records, source documents, and maintain essential files.

Document study communications, protocol deviations, adverse events, and maintain regulatory reporting with IRB and investigators.

Liaise with sponsors, monitors, County Ministry of Health teams, CHMT, CAB, and other partners; prepare for monitoring and close-out visits.

Support field logistics including supplies, reimbursements, payments, troubleshooting site issues, and preparation of field and progress reports for the PI.

Any other duties as assigned by PI

Qualifications or requirements (e.g., education, skills)

Diploma in Clinical Medicine & Surgery/Community health from a recognized institution.

Must be registered with the Clinical Officers’ Council

Proficiency in computer application skills

Understanding and experience working with the primary healthcare system

Ability to communicate with tact and diplomacy

Ability to read and understand complex clinical research documents

Ability to work effectively in a fast-paced, team-based environment

Ability to prioritize tasks, establish timelines and meet multiple deadlines on concurrent projects/study cohorts

Ability to establish cooperative working relationships with patients, co-workers, & physicians

Excellent analytical and problem-solving skills

Experience needed

Experience in conducting clinical research trials in busy clinical research environments with related quality assurance/quality control (QA/QC) activities is desirable.

• Coordinate and supervise field collection teams and overall field operations.
• Oversee study activities including chart preparation, scheduling protocol-specific procedures, consent administration, SOPs, and training of clinical staff.
• Support the PI in informed consent administration in compliance with study protocols, local regulations, and GCP guidelines.
• Ensure accurate data collection, workflow adherence, data capture in eCRFs/CRFs, and resolution of data discrepancies.
• Monitor study compliance with protocols and GCP; audit study records, source documents, and maintain essential files.
• Document study communications, protocol deviations, adverse events, and maintain regulatory reporting with IRB and investigators.
• Liaise with sponsors, monitors, County Ministry of Health teams, CHMT, CAB, and other partners; prepare for monitoring and close-out visits.
• Support field logistics including supplies, reimbursements, payments, troubleshooting site issues, and preparation of field and progress reports for the PI.
• Any other duties as assigned by PI

• Proficiency in computer application skills
• Ability to communicate with tact and diplomacy
• Ability to read and understand complex clinical research documents
• Ability to work effectively in a fast-paced, team-based environment
• Ability to prioritize tasks, establish timelines and meet multiple deadlines on concurrent projects/study cohorts
• Ability to establish cooperative working relationships with patients, co-workers, & physicians
• Excellent analytical and problem-solving skills

• Diploma in Clinical Medicine & Surgery/Community health from a recognized institution.
• Must be registered with the Clinical Officers’ Council
• Understanding and experience working with the primary healthcare system
• Experience in conducting clinical research trials in busy clinical research environments with related quality assurance/quality control (QA/QC) activities is desirable.