Clinical Research Specialist III

integratedresourcesinc
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📍 MN📍 Mounds View📍 Mounds View, MN, United States📍 us

About this role

Company 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.


Qualifications

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
“INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)

Frequently Asked Questions

Is the salary disclosed for the Clinical Research Specialist III position at integratedresourcesinc?
The salary for this Clinical Research Specialist III role at integratedresourcesinc is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Clinical Research Specialist III position at integratedresourcesinc located?
This Clinical Research Specialist III role at integratedresourcesinc is based in MN, Mounds View, Mounds View, MN, United States, us. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
How do I apply for the Clinical Research Specialist III position at integratedresourcesinc?
Click the "Apply Now" button on this page. You will be redirected to integratedresourcesinc's official application portal hosted on smartrecruiters where you can submit your application directly.
When was the Clinical Research Specialist III job at integratedresourcesinc posted?
This Clinical Research Specialist III position at integratedresourcesinc was posted on Aug 10, 2016. Apply as soon as possible — early applications are often reviewed first.
Clinical Research Specialist III
integratedresourcesinc
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