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.
  
  
  

We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job.

Thanks & Regards,

Seema Chawhan
Clinical Recruiter
Integrated Resources, Inc.
IT Life Sciences Allied Healthcare CRO
Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I
DIRECT # - 732-844-8724
Email id – seema @irionline.com| www.irionline.com
LinkedIn: https://in.linkedin.com/in/seemachawhan
Gold Seal JCAHO Certified ™ for Health Care Staffing
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