Clinical Research Associate Career Profile

Clinical Research Associate

• Identification of key investigators
• Assistance in the preparation of regulatory submissions
• Design patient information sheets and consent forms
• Coordinate document translation and verification
• Ensure timely submission of protocol/consent documents/safety reports for Ethics/IRB approval according to local requirements
• Pre-study and initiation visits
• Conduct regular monitoring visits in accordance with the trial site monitoring SOP
• Maintain all files and documentation pertaining to studies
• Motivate investigators in order to achieve recruitment targets
• Complete accurate study status reports.
• Ensure the correct storage of drugs and the diligent account of all drugs in accordance with SOPs
• Keep the project manager regularly informed
• Process case record forms to the required quality standards and timelines
• Ensure the satisfactory close-out of investigator sites
• Ensure correct archiving of files on completion of a study
• Co-operate with QA personnel in the conduct of QA audits
• Participate in feasibility studies for new proposals
• Maintain patient confidentiality

• Degree in Life Sciences or Equivalent
• Ability and willingness to travel at least 50% of the time, both international and local
• Ability to review and evaluate clinical data
• Computer literacy desirable
• Foreign language skills desirable
• Current full driving license essential
• Good oral and written communication skills