Description and purpose:

To coordinate and ensure timely identification, accurate documentation, reporting, follow up and training for all adverse events on site and communication to the regulatory bodies as well as provide medical services in the examination, treatment and follow up of study patients and participants in all technical and administrative activities meant to foster the objectives of the research collaboration

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 judgement, 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.

 

Applications with complete C.Vs, including 3 referees and their full addresses or contact Tel No.’s, copies of academic certificates and testimonials, should be emailed to  HR@mujhu.org or hand delivered to: MU-JHU Reception Room 12, located in MU-JHU 1 Building – not later than 9th  February, 2023 by 5:30p.m. Only short listed applicants will be contacted.  

 

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