Description
Roles:- Able to independently manage the study start up activities for a multi-center, US based IVD study
- Create project specific documents and tools (monitoring plan, meeting materials, tracking spreadsheets and databases, training tools, manuals, etc)
- Responsible for clinical site training and adherence of the site to protocol, applicable ICH/GCP guidelines, regulations, statutes, and SOPs
- Mentor and coach junio staff; CTAs
- Conduct study qualification visits for the purpose of assessing the site's ability to effectively conduct the trial per SOP and study guidelines
- Other duties and assignments as needed for the overall success of studies
Requirements:
- Strongly prefer RN background; will consider BS/BA as well
- Must have at least 5 years of clinical trial monitoring experience
- Prefer OB and diagnostic experience
- Experience managing sites in large, multi-site clinical studies
- TRAVEL (up to 40 %) as required
To find out more about Real please visit www.realstaffing.com