Job Title: Clinical Research Specialist III
Location: Mounds View, MN
Duration: 4+ Months (Possibility of extension)
Job Roles & Responsibilities
Main duties of project are as follows:
·Extensive review of Trial Master File and Site Files to ensure files are complete, accurate and compliant with ISO14155, applicable FDA Code of Federal Regulations, project plans and MDT internal SOPs.
·Critical review of target records, to identify any audit risks; recommend or take action to mitigate risks
·Document file review, all findings and actions as a deliverable to the Clinical Trial Manager
Experience required: 5 plus years
Educational: Bachelor’s degree required.
Top 3 skills needed
·Experience with BIMO Audits and Audit prep
·Audit background good organizational skills.
·Strong working knowledge of documentation required for FDA and ISO 41455 audits.