Description
Primary Responsibilities:- Set-up and maintain all study and clinical operations files for assigned clinical trials
- Route, track, and receive all essential clinical documents and business with CROs, other departments, sites, partnership collaborations, and vendors
- Maintain study documents, binders, manuals, and supplies to ensure adequate inventory for Clinical Operations and clinical sites
- Assist in the set-up and coordination of clinical activities and meetings
- Maintain databases and tracking systems and review reports from various data sources (including the Clinical Trial Management System)
- Maintain quality records and documentation for ensuring compliance with FDA regulations, ICH guidelines, and company SOPs and guidelines
- Review and assist in the revision of department SOPs
- Collaborate with department members to identify Clinical Operations' process needs
- Works with supervisor and Clinical Operations team to achieve corporate goals and departmental goals within the expected time frames
- Assisting other departments, e.g. QA and/or RA, as needed with the Document Control System and regulatory submissions
Education/Experience:
- Bachelor's degree in a scientific discipline or equivalent preferred
- Minimum 3 years clinical research experience at a clinical site, sponsor company or CRO
- Strong communication skills (verbal and written) and high degree of professionalism
- Highly organized and flexible team player that is able to asses priorities, multi-task, and meet deadlines
To find out more about Real please visit www.realstaffing.com