Clinical Research Specialist III

Job Title: Clinical Research Specialist III

Location: Mounds View, MN
Duration: 4+ Months (Possibility of extension)

Job Roles & Responsibilities

• Senior level Clinical Research Specialist with proficiency in BIMO audit preparation needed.
• Team is preparing for a PMA (pre market application) submission.

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.

• Full time hours - 40/week.