|Position:||Clinical Research Project Coordinator|
|Education Level:||Bachelor's Degree|
|Experience Level:||Experienced (Non-Manager)|
Responsible for overseeing and managing all functions of the studies as assigned within the Clinical Research Department to ensure successful closure of each study protocol with accurate data reported to the Sponsor/CRO.
Management of Monthly Data Reporting
Resolution of any queries received from Sponsor/CRO
Manage vendor calls with formalized agendas and meeting minutes
Resolution of any outstanding items from meetings and for site needs
Ensure study is conducted within regulatory compliance and industry best standards, any issues encountered are escalated to CMO & Managing Director for resolution
Complete study-specific documents for distribution to Sites
Oversee completion of study matrix for each assigned study for use in marketing materials
1-3 years of clinical research experience managing global trials to include compliance and data management.
Extensive knowledge of HIPAA, ICH-GCP, 21 CFR 11, GDRP, and other applicable regulations.
Strong interpersonal skills with the ability to respond professionally with clients and internal personnel from international cultures whose primary language may not be English.
Preferred: Bachelor’s degree from an accredited four-year university.