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Clinical Research Associate
Lesser Poland
Wygasła: 31.08.2022
full-time
umowa o pracę
home office work
specialist (Mid / Regular)
Obowiązki:
Responsible for the monitoring of clinical trials and tracking study progress for our clients
Collect study related data and assist with the preparation, review and submission of regulatory documents to regulatory authorities
Contribute to the overall management of trials in accordance with ICH-GCP standards, local requirements and SOPs
Start-up, maintenance and closure activities of clinical studies including the maintenance of the TMF and study documentation
Monitor on-site clinical trials in accordance with Clinical Consulting and/or client company Standard Operating Procedures, FDA regulations, and GCP and ICH guidelines
Review CRFs (paper or electronic) and subject source documentation for validity and accuracy and generate queries to investigational sites/clients to resolve problem data
Set up ISF and SMF (or cooperate with CTA) and distribute to the investigational sites
Update CTMS system with site and study information
May assist in the preparation of study documentation such as CRF Completion Guidelines, patient diaries, study participation cards by reviewing for accuracy and completeness