The Ugandan Jobline

• Ensure
  that the study is implemented in compliance with the study protocol
  and that any deviations are properly documented and communicated
• Actively
  participate in the development and adaptation of Standard Operating
  Procedures
• Initiate
  and coordinate the process of obtaining study approval from the local
  Regulatory Authorities and Ethics Committee bodies, as applicable
• The
  Research Assistant will maintain a Study Trial Investigator file
  containing all essentials documents
• Submit
  any substantial amendment of protocols or patient information and informed
  consent forms for approval to the local Regulatory Authorities and Ethical
  bodies
• The
  incumbent will plan and execute the initial and continuous training
  of staff related to the study in coordination with the international
  principal investigator and study monitor
• Ensure
  all members of research team he is in charge of conduct the study in
  accordance to GCP regulations in agreement with protocol and study
  related SOPs
• Record
  and promptly report Serious Adverse Reactions and other notifiable events
  to the Sponsor, relevant local ethics and regulatory authorities
• Ensure
  that data is collected, recorded, handled, stored and reported accurately
  on Case Report Forms and confidentiality is kept
• Ensure
  the adequate medical care of study participants for any adverse event
• Supervise
  and advise the study doctors, nurses, field workers in performance of
  their duties
• Regularly
  monitor study materials including but not limited to drugs, sundries,
  diagnostic tools
• Prepare
  together with the pharmacist orders materials and drugs needed for the
  running of the study
• Generate
  timely study reports and contribute to writing of monthly site report
• Communicate
  regularly with international principal investigator.
• Participate
  regularly in meetings and other activities of the medical department and
  the research centre as a whole when required
• Communicate
  regularly with international principal investigator
• Take
  up any other responsibilities delegated to them by the Medical Coordinator
  and the Director of the Centre
• Ensure
  good communication with other investigators and the study team.

• The
  applicant must be a Medical doctor with advanced training in clinical
  research, epidemiology or public health
• Registered
  with Medical and Dental Practitioners Council
• Previous
  experience on clinical trial study implementation is an asset
• Extensive
  knowledge of ICH guidelines, GCP, and the clinical trial study process
• Demonstrated
  ability to work effectively in teams as well as independently
• Excellent
  verbal and written communication skills
• Additional
  Training in Good Clinical Practice

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