Key Responsibilities
- 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 the PI.
Vacancy Requirements
- Diploma in Clinical Medicine & Surgery / Community Health from a recognized institution.
- Experience in conducting clinical research trials in busy clinical research environments with related QA/QC activities is an added advantage.
- 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, and physicians.
- Excellent analytical and problem-solving skills.
