Description
Clinical Trial Conduct Responsibilities:- Set-up and maintain all study and Clinical Operations files for assigned clinical study(ies)
- 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, prepare meeting minutes as requested
- 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
- Other duties as assigned
- Assists with preparing for meetings such as investigator meetings, partner meetings, scientific meetings, etc. as requested
Departmental Responsibilities:
- 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
Work Experience:
Prefer a minimum of 1 year of clinical research experience working at a clinical trial site, CRO, or Sponsor company
To find out more about Real please visit www.realstaffing.com