Description:
Main purpose of the job:The post-holder will be responsible for overall management and coordination of an observational study and a multisite phase 3 randomised clinical trial of antifungal treatment for candidemia (COMBAT Candida), which will take place at 5 hospital sites in Johannesburg As a member of the trial management group in South Africa, they will work closely with the project co-ordinator, co-investigators, trial epidemiologist and statisticians in the UK, the site investigators and study coordinators at the study sites, the laboratory scientists, lead clinician, data management and administration team at Wits Mycology The applicant will be expected to be based full-time at the coordinating site in Johannesburg for the duration of study recruitment Location:
1 Modderfontein Road, Sandringham, Johannesburg Key performance areas:
Day to day management of the phase 3 clinical trial and ensuring compliance with the study protocol and international standards of Good Clinical Practice (GCP) Coordinating applications to ethical and regulatory bodies Perform site visits for trial set up and initiation, regular monitoring visits during patient recruitment, and close out visits on trial completion Organising and facilitating meetings and assisting with communications, including Trial Management Group, Trial Steering Committee, Investigator, and Data Monitoring Committee meetings Liaising with study sites, the data management team, and study epidemiologists and statisticians to ensure follow-up information is kept up-to-date, accurately completed and that loss of patient data is prevented Ensure that all trial adverse events are appropriately investigated by the study staff and accurately reported to the principal investigators Maintaining liaison with partner institutions and funders To assist with organisation and coordination of related projects and funding applications where necessary, to procure required trial consumables and monitor the trial budget To assist the chief and co-investigators with preparation of trial materials including updated protocol, consent, patient information, case record and adverse event forms and standard operating procedures for trial sites To visit hospital sites for purpose of trial set-up and initiation, and monitoring, and co-ordinate and promote communication between the centres and the trial coordinating centre, allowing early recognition and resolution of any difficulties To prepare research progress and monitoring reports for, organise and minute regular meetings with the Trial Management Group, Trial Steering Committee and Data Monitoring Committee To organise meetings, as necessary, with study team members and collaborators, including programmes, accommodation, travel, venues and social events
19 Jun 2025;
from:
gumtree.co.za