Graduate CRA, Beijing
About the role
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- Assisting with the Identification of investigators.
- Help, when requested, in preparation of regulatory submissions.
- Design patient information sheets and consent forms.
- Coordinate documents translation, verification and back translations where required.
- Ensure timely submission of protocol/consent documents/safety reports for Ethics/IRB approval according to local requirements.
- Pre-study/placement and initiation visits.
- Conduct regular monitoring visits in accordance with the ICON site monitoring SOP/Sponsor site monitoring SOP/WP, as appropriate
- Maintain all files and documentation pertaining to studies.
- Motivate investigators in order to achieve recruitment targets.
- Complete accurate study status reports.
- Deal with sponsor generated queries in a timely manner.
- Ensure the satisfactory close-out of investigator sites.
- Ensure correct archiving of files on completion of a study.
- Co-operate with sponsor and/or ICON QA personnel in the conduct of QA audits.
- Participate in feasibility studies for new proposals, as required
Requirements
- Ability to review and evaluate clinical data.
- Computer literacy
- Good oral and written communication skills.
- Bachelors degree, or local equivalent, in medicine, science or related discipline.
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