Role Overview
You will be the frontline clinical research professional responsible for guiding participants through an HIV prevention study from their first contact through the final follow-up visit. Your daily work directly affects data quality, participant safety, and the study's ability to produce reliable results, so you will balance patient-centered care with strict adherence to protocol and regulatory standards. Working across clinical, laboratory, and data teams, you will ensure every interaction is ethically sound, accurately documented, and aligned with Good Clinical Practice.
Key Responsibilities
- Drive participant enrollment by identifying eligible individuals, explaining study objectives and procedures in clear terms, obtaining informed consent, and managing onboarding logistics from screening through randomisation.
- Deliver protocol-defined study procedures, including administering structured questionnaires and capturing demographic, behavioural, and clinical information with precision and consistency.
- Provide practical, non-judgmental counselling on HIV and STI prevention, contraceptive options, risk reduction, and proper use of study products, adapting your approach to each participant's circumstances and literacy level.
- Maintain high retention by coordinating appointment schedules, sending reminders, tracing participants who miss visits, and resolving practical barriers that could lead to loss to follow-up.
- Keep meticulous source documents and case report forms, enter data into REDCap and other approved systems in a timely manner, and reconcile records to prevent errors or omissions.
- Monitor the study database for completeness and protocol compliance, respond to data queries, and escalate safety signals such as adverse events, social harms, or protocol deviations according to established procedures.
- Liaise closely with laboratory, pharmacy, clinical, qualitative research, and data management colleagues to ensure seamless workflows and prepare participant files for monitoring visits, audits, and inspections.
- Protect participant confidentiality at all times, attend required trainings and team meetings, and step in to support additional study duties as operational needs arise.
Requirements & Qualifications
- Diploma or Bachelor's degree in Nursing from a recognised institution, with active nursing registration and licensure in the applicable jurisdiction.
- At least 2–3 years of direct experience in clinical research, clinical trials, or a comparable healthcare setting where you handled patient-facing responsibilities and documented care.
- Current Good Clinical Practice (GCP) and Human Subjects Protection (HSP) certification, with working knowledge of ethical guidelines and regulatory requirements governing human research.
- Demonstrated ability to explain complex medical concepts to diverse populations and to maintain clear, empathetic verbal and written communication even under pressure.
- Strong organisational and time-management skills, including the capacity to prioritise competing tasks, manage multiple participant schedules, and sustain high attention to detail over long study timelines.
- Comfort working both independently and as part of a multidisciplinary team, showing initiative, problem-solving judgment, and resourcefulness when unexpected challenges arise.
- Proficiency with electronic data capture tools such as REDCap, as well as standard word processing and spreadsheet applications, is strongly preferred.
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