Freelance Local Contact Person for Pharmacovigilance and Regulatory - Cairo, مصر - Cairo Governorate, EgyptCairo

وصف

Responsiblity:

• Creating and writing trial protocols, and presenting these to the steering committee.
• Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial.
• Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
• Liaise with the ethics committee regarding the rights, safety, and well-being of trial subjects.
• Ordering, tracking, and managing IP and trial materials.
• Overseeing and documenting IP dispensing inventory, and reconciliation.
• Protecting subjects' confidentiality, updating their information, and verifying IP have been dispensed and administered according to protocol.
• Conducting regular site visits, coordinating project meetings, and writing visit reports.
• Implementing action plans for sites not meeting expectations.
• Liaising with regulatory authorities.
• Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
• Other tasks and responsibilities as needed.