Clinical Research Specialist III

Integrated Resources Inc.; Mounds View (MN); On-site; USD 75,000 - 100,000; Full time

Job summary

A leading staffing firm is seeking a Clinical Research Specialist III in Mounds View, MN for a 4+ month engagement, with responsibilities focusing on BIMO audit preparation and compliance reviews. Candidates should possess a Bachelor’s degree, along with over five years of relevant experience and expertise in documentation for FDA audits.

Qualifications

• 5+ years of experience in clinical research.
• Strong knowledge of FDA and ISO 14155 standards.
• Proficiency in BIMO audit preparation.

Responsibilities

• Review Trial Master File and ensure compliance with ISO14155.
• Identify audit risks and mitigate them.
• Document findings and actions for the Clinical Trial Manager.

Skills

BIMO Audits

Audit preparation

Organizational skills

Documentation for FDA audits

Education

Bachelor's degree

Job description

Integrated 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 Description

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.
  
  

Additional Information

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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