Clinical trials monitoring in accordance with the ICH Guidelines, the current monitor guidelines and SOPs. identifying sites, preparing documentation for necessary approvals, Feasibility and Qualification of sites, initiating sites and observing recruitment, performing monitoring at sites, reporting visits and contacts with site, assuring the presence of all relevant documents on site, collaborating with other departments for reporting safety information, collecting Case Report Forms, following up and solving data queries, reporting the progress of the study on a regular basis, preparation of audit and performing site close-out visits.
Project management activities:
- Kick-off meetings
- Conducting protocol, study procedures and ICH-GCP trainings to investigational teams
- Coordinating vendors and ancillary tasks (payments/reimbursements, Central laboratory, contracts, etc.) with in-house project team.
- Performing drug accountability reconciliation and IWRS management.
- Detecting protocol/procedure deviations/deficiencies and implementing CAPA processes
Regulatory affairs activities:
- Submission to IEC, ANSM, National Physician Council, CNIL (La Réunion)
- Application of Trial License to CRRC and submission to EC and local EC (Mauritius).
Site coordination activities:
- CRFs completion
- Reimbursement of patients.