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Clinical Research Associate
About this role
AIBT seeks a detail‑oriented Clinical Research Associate to support and oversee clinical trials, ensuring adherence to study protocols, GCP, regulatory requirements, and ethical standards. The role focuses on monitoring trial sites, validating data accuracy, safeguarding participant safety, and maintaining trial documentation. The successful candidate will collaborate with investigators, coordinators, data managers, medical monitors, and sponsors to support trial progress and regulatory compliance. The position targets individuals with practical experience in clinical research, monitoring, and documentation, who can travel to trial sites as needed. The employer is Athena Institute of Business and Technology (AIBT), which aims to develop Africa’s future leaders in business, policy, and technology through practical, impact‑driven learning.
What you would do
- Conduct site initiation, routine monitoring, and close‑out visits for clinical trials.
- Ensure activities comply with GCP, regulatory requirements, and policies.
- Monitor trial sites for adherence to protocols, informed consent, and participant eligibility.
- Review source documents, case report forms, and electronic data capture for accuracy and consistency.
- Verify informed consent is obtained and documented before procedures.
- Monitor participant safety and ensure proper reporting of adverse events.
- Assess investigational product handling and documentation where applicable.
- Identify deviations, data discrepancies, and risks; collaborate on corrective actions.
- Prepare and maintain monitoring reports, letters, and site documentation.
- Support site feasibility, initiation, recruitment monitoring, and trial close‑out activities.
What they are asking for
- Bachelor’s degree in Nursing, Pharmacy, Medicine, Biological Sciences, Biomedical Sciences, Public Health or related life sciences discipline.
- Postgraduate qualification in Clinical Research, Public Health, Epidemiology, or related field is an advantage.
- Current or desirable training in ICH GCP.
- Professional certifications in clinical research or trial management are advantageous.
- 2–4 years of relevant clinical research experience, including monitoring and data review.
- Experience supporting or monitoring trials in line with protocols and GCP.
- Familiarity with site monitoring, data queries, protocol deviations, and study documentation.
- Experience preparing monitoring reports and audit readiness.
- Understanding of participant safety reporting and quality management in trials.
- Willingness to travel to trial sites as required.
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