The Ugandan Jobline

• Act as the focal point for headquarters for vaccine clinical trials
  conducted at Epicentre Mbarara;
• Monitor the progress of the trials and ensure studies are
  implemented in compliance with the study protocol and in accordance with
  GCP regulations;
• Support research assistants in the development and adaptation of
  Standard Operating Procedures;
• Ensure appropriate care of participants and follow-up serious
  adverse events until resolution;
• Work closely with research assistants and pharmacist to prepare
  orders and monitor stock;
• Provide technical supervision to all members of the medical team and
  ensure the quality of the health care provided within the research
  studies;
• Organize and participate in trainings according to needs.

• Act as focal point with principal investigators and sponsors, in
  coordination with research assistants and relevant team members in Paris;
• Work in close collaboration with principal investigators and
  sponsors, ensure the approval processes from the local and National
  Regulatory Authority and Ethics Committee bodies, as applicable, including
  amendments of protocol and informed consent forms;
• Work in liaison with research assistants, ensure follow-up of
  reporting notifiable events to the Sponsor, relevant local ethics and
  regulatory authorities;
• Participate in the development of study reports (ethics committees,
  regulatory authorities and sponsors);
• Consolidate monthly site reports;
• Communicate regularly with Sponsors, principal investigators and
  partners ensuring that communication is fluid and any difficulties tracked
  and resolved appropriately;
• Participate in relevant external study meetings and act as a
  representative of Epicentre.

• Coordinate and ensure that studies are on time and on budget in
  collaboration with the Resource Manager in Mbarara as well as the
  financial team in Paris;
• Ensure that the vaccine clinical trials are adequately staffed for
  the medical part and that medical staff are adequately recruited in terms
  of skills and qualifications;
• Together with relevant team members in Paris, resources coordinator,
  and logistics manager, organize the administrative and logistics support;
• Coordinate with the pharmacist coordinator, lab coordinator and
  other team members to ensure problems are resolved promptly and
  anticipated.

• Participate regularly in meetings and other activities of the
  medical department and the research centre as a whole when required;
• Take up any other responsibilities delegated by relevant team members
  in Paris, 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
• Training in Good Clinical Practice
• Previous experience on clinical trial study implementation and
  coordination
• Knowledge of ICH guidelines, GCP, and the clinical trial study
  process
• Ability to work effectively in teams as well as independently
• Excellent verbal and written communication skills

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