Clinical Trial Specialist

Company Name:
Koch Davis
Conduct country specific feasibility and site pre qualification. Review and validate site identification list. Collect and negotiate confidentially agreements as required. Customize, review, configure, and negotiate as required country/site specific informed consent forms and their amendments. Organize translations per country/regulatory/client requirements. Review and approve country specific and site specific documents or essential regulatory documents. Prepare and submit IRB/IEC application and follow up until final approval received. Prepare and negotiate as required initial and/or amended CSA at a site level. Resolve CSA changes requested by the site and approve any change in CSA language with support from Site Contract Leader as required. Collect internal CSA signatures. Complete routine departmental administrative tasks in an accurate and timely manner. Proactively keep manager informed about work progress and any issues. Ensure basic understanding of project scope, milestones, budgets, and time codes and strive for high quality, timely, and efficient delivery. Update all appropriate Clinical Trial Management Systems as indicated per function on an ongoing basis and submit all relevant documents to central files per the Central File Maintenance Plan.
Proactively work with other project team members to meet project goals. Show commitment and perform consistent high quality work.
Not Specified
This hiring company specializes in the Environmental, Civil, Geo-technical and Construction Management. Provides technical, professional and industrial staffing services to support nearly every industry.

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