• Proposed job title : Field Clinical Research Associate
• Job Responsibilities:
The FCRA will be assigned to multiple DEVICE clinical trials across BU (mainly in cardiovascular area). In Abbott, FCRA is not only responsible for the on-site monitoring, but is dedicated to the whole period of study cycle from site feasibility, start-up, site activation to closure.
Main responsibilities as below:
• Support selection of clinical research centers.
• Perform clinical research site assessment to evaluate the expected performance level for a specific protocol.
• Be an efficient communication link between the Clinical Development department and the clinical research centers.
• Developing/maintaining relationships with site investigators and research staff.
• Collect essential documents for clinical research site.
• Work with site and local Regulatory Affairs representative (if applicable) to prepare Ethic Committee submission and obtain approval(s).
• Work with site and internal team on site clinical trial agreement negotiation and finalization.
• Follow Competent Authority notification and submission.
• Site Initiation for clinical Studies in compliance with company SOPs, ISO 14155, study protocol, monitoring plan and applicable local and international regulations.
• Conduct Monitoring of clinical trials in compliance with company SOPs, study protocol, ISO 14155, monitoring plan and applicable local and international regulations.
• Perform other related functions and responsibilities, on occasion, as assigned.
• Educational Requirements: Bachelor‘s Degree and above in biological science, pharmacy or other health related discipline
• Experience and Requirements:
• 2-year CRA experience is preferred.(CRA experience is must)
• Strong organizational, planning and prioritization skills and can function as part of a team
• Good verbal and written communication skills in Chinese and English
• Good Presentation skills
• Problem identification and solving skills
• Costumer focused and self-motivated
• Detail and quality oriented.
• Stress management techniques