Clinical Research Associate

Job description

We are looking for an organized, flexible clinical research associate to oversee clinical trials. The CRA should maintain and manage the monitoring and sites’ management related activities at the different stages of clinical trial(s). Accordingly, he/she will conduct regular on-site visits and maintain continuous communication with the investigational sites.

Responsibilities

• Training site staff on the applicable therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
• Identifying, evaluating, and initiating trial sites, and closing sites down on completion of the trial.
• Overseeing and documenting investigational device inventory, and reconciliation.
• Protecting subjects’ confidentiality, updating their information, and verifying investigational device have been dispensed and administered according to protocol.
• Conducting regular site visits, coordinating project meetings, and writing visit reports.
• Liaising with regulatory authorities.
• Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines.
• Other tasks and responsibilities as may be needed.

Requirements

• Previous experience of at least two years as a CRA, in clinical research of medical devices’ studies.
• Knowledge of the ISO14155 requirements for the conduct of clinical trials in medical devices
• Verbal and written communication skills.
• Ability to work independently.
• Ability to manage and prioritize workload effectively.
• Ability to travel to perform on-site visits.