IHCRA
About the role
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The Role
- Become familiar with ICON's SOPs/WPs, ICH GCP guidelines, appropriate regulations, ICON systems and the principles of and assist with investigator recruitment
- Maintain timelines and ensure accuracy and completeness of data entered into ICON systems
- Serve as the primary in-house contact for sites and investigators participating in studies
- Conduct and completes remote site management activities, with support as needed, according to applicable SOPS and the Study Monitoring Plan.
- To contact Clinical sites for specific requests (e.g. enrolment updates, missing documentation, data entry timeliness, data query follow-up, CDA finding follow-up, and action Item resolution or other sponsor specific CRA tasks.
- Take responsibility for project tasks and sees these tasks through to successful completion, with support.
- Maintain a professional interpersonal relationship with study team, sites, and Sponsors
- Participate in QA Audits as needed.
- Regularly attend and gives to project specific and departmental meetings
- Ability and willingness to travel as needed (drive and fly)
- Maintain Sponsor and patient confidentiality
- Other duties as assigned
- Minimum Bachelor's degree in a life science
- At least 12 months of a CTA/Clinical Trial Assistant or similar role experience within the clinical/pharmaceutical industry
- Understanding of ICH GCP Compliance
- Excellent communication and organizational skills
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Day in the life
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Summary
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