临床监察员CRA

该职位来源于猎聘 临床监察员CRA Major Responsibilities and Duties

• Ensure all business is conducted professionally in compliance with company policies and procedures.
• Maintains working knowledge of protocols and Monitoring Plans for assigned projects.
• Responsible for leading the EC submission team for GCP office pre-review and EC submission to meet start up timeline.
• Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period;
• Responsible for scheduling and conducting of pre-study visits, initiation visits, interim monitoring visits and close-out visits according to the Monitoring Plan.
• Ensures assigned sites are conducting studies according to protocol requirements.
• Reconciles site regulatory binder assuring collection and completeness of regulatory documents.
• Collects and ensures completeness of all essential regulatory documentation from sites from study start-up through close-out.
• Verifies that written informed consent was obtained before each subject’s participation in the trial;
• Verifies that the investigator is enrolling only eligible subjects.
• Performs verification of source document s against Case Report Form/Electronic Data Capture entries to assure accurate and complete data. Ensures that any corrections are appropriately documented by authorized site staff.
• Issues and ensures timely resolution of all data queries. Qualifications
• Bachelor degree or above, Education with medical or pharmacy background.
• More than 1 year CRA working experience on oncology study will be preferred.
• Good written and verbal communications skills both in Chinese and English.
• Good computer skills.
• Self-motivated, have team-spirit, can work under pressure.
• Ability to travel as required.