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 E 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. 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| LinkedIn: Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5000’s FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row) 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.