Regional Clinical Research Associate
Visited sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, to review data and ensure data collected from start up to termination of studies and to terminate studies.
- Implemented and monitored clinical trials to ensure sponsor and investigator obligations are being met and compliant with applicable local regulatory requirements and ICH guidelines.
- Performed investigative site file reconciliation, requests any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents and compliance with appropriate local regulatory requirements, ICH guidelines, project SOPs and sponsor requirements.
- Performed source document verification, retrieves case report forms (CRFs) and performs query resolution in a timely manner and oversees drug accountability and safety at investigative sites
- Ensured Serious Adverse Event (SAE) reporting according to project specifications, reviews SAE information, resolves queries and assists sites in completion of SAE reports.
- Generated reports for site and project management using CTMS.
- Required to travel 70% of the time.