We are seeking a Consultant for the Clinical Operations Team at the International Vaccine Institute.
Job Description
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.Key responsibilities
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.
Job Requirements and Qualifications
Bachelorโs 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