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Clinical Research Specialist III

Integrated Resources, Inc

Mounds View, Minnesota

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
Clinical Research, Clinical Trial, Code of Federal Regulations, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Information Technology & Information Systems, Project Planning, Rehabilitation Nursing, Risk Analysis, Risk Management, Standard Operating Procedures (SOP)
LOCATION
Mounds View, Minnesota
POSTED
Today
Clinical Research Specialist IIIIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.Job DescriptionJob Title: Clinical Research Specialist IIILocation: Mounds View, MN Duration: 4+ Months (Possibility of extension) Job Roles & ResponsibilitiesSenior 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 ManagerExperience required : 5 plus yearsE ducational: 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.

About the Company

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Integrated Resources, Inc