• Site Selection: Participate in the evaluation and recruitment of suitable investigators; prepare, conduct and report Site Selection Visits
• Regulatory and Ethics Committee Submissions: Responsible for applications; prepare and submit applications to the local Competent Authorities and Ethics Committee(s); ensure that country-specific ICF fulfills protocol and local requirements
• Initiation: Responsible for setting up study files; prepare, conduct and report Site Initiation Visits
• Monitoring: Ensure that stipulated timelines and goals are met; prepare, conduct and report Site Monitoring Visits; safety reporting within timelines
• Study Close-Out: Prepare, conduct and report Site Close-Out Visits
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CRA has scientific or health care education and at least two years of experience of working in the field of clinical research.
The following skills and attributes are required from CRA:
• Understanding of SOPs, EU and local regulatory requirements and ICH GCP guidelines
• Strong organizational, documentation, and interpersonal skills and willingness to work in a team-oriented environment
• Excellent command of written and spoken local language and English
• Good computer skills
• Ability to handle multiple tasks to meet deadlines in a dynamic environment
Lisainfo
For additional information, please contact +372 514 4270
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