We are seeking a Consultant for the Clinical Operations Team at the International Vaccine Institute.

• This position is responsible for monitoring vaccine studies in the East African region. Ideally, based in the same study location. Previous independent on-site monitoring experience is essential for this role.

• Perform site selection, initiation, monitoring, and close-out visits and work with sites to adapt, drive, and track subject recruitment plans
• Provide monitoring visits and site management for vaccine protocol
• Administer protocol and related study training to assigned sites and establish regular lines of communication
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution.
• Create and maintain appropriate documentation regarding site management, monitoring visit findings, and action plans
• Collaborate and liaise with study team members as appropriate.

• Bachelor’s degree in Life Sciences or other scientific/nursing disciplines is essential
• Minimum of 2 years of independent site monitoring experience and CRO experience is highly desired
• Ability to travel regularly which will involve interstate travel
• Extensive knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines is required
• Require bilingual in English and French communications
• Fluency in English