Required qualifications and profile:
A degree in Medicine (MBChB) with at least 2 years’ working experience in clinical trials and good clinical skills in a busy research/health institution. Experience in a clinical research setting would represent additional relevant experience.
The desired person must be able and willing to work independently, multi-task and possess strong judgment, communication and interpersonal skills and a strong commitment to client service.

The holder of this position will work under the supervision of the Program Manager, with guidance of the Clinical Division Director and will be responsible for the following:
• Identify AE for reporting, following communication from study doctors/QC/ hospital records or Health Visitors promptly.
• Review study lab results to identify SAE/AE promptly.
• Promptly review any participant with a reported AE, document any additional findings and liaise with the hospital teams for further management as appropriate
• Ensure detailed, complete and accurate documentation of AE and availability of all supporting documentation for AE.
• Liaise with Program Manager/designee to review reports for accuracy and completeness
• Update/ resolve AE promptly in source files/ data bases and IRB reports.
• Communicate with Health Visitor’s to follow-up on AE.
• Follow-up and respond to any SAE/AE queries from regulatory bodies/sponsor/industrial partners
• Review admitted participants with SAE/EAE as well as examining and treating other study participants as required
• Facilitate regular trainings on SAE/updates for staff on study teams.