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Anti-Infectives In-House CRA
| Details |
Country: USA
Location: Kenilworth NJ
Total applied: 33
Location: US-NJ-Kenilworth
Job Category:Pharmaceutical |
|
Anti-Infectives In-House CRA
Purpose: SUMMARY: This is a new group within a department which consists of 50 people. A candidate will be working on phase II-III studies. There will be minimal travel, mostly consisting of investigator meetings of about 15-20%.
REQUIREMENTS:
*Minimum of three year's of direct industry CRA monitoring experience required with a minimum total related clinical research experience of four years.
*Prior Anti-Infectives monitoring experience preferred (must
detail types and amount of experience, indications worked on and, monitoring experience details)
*Familiarity with CRF and database design is required.
*Major Pharmaceutical company or major CRO experience preferred (preferably as an in-house CRA)
*Previous experience in review of data listings, generation of and tracking of queries to closure is required
*Master study file reconciliation
*Discrepancy Resolution Management across sites
*CRF review, pagination, and sign-off
*Advance Report Updates
*Status Reporting
*Regulatory Document Review
*Milestone Maintenance in Study management plan.
*Protocol Amendment Preparation/Management
*Clinical Documentation dept liaison
*Hands-on Ms Office applications skills required.
*BS degree required, preferably in life sciencesClassification:ContractCompensation:
based on experience HourJoin Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries is an equal opportunity employer.
Required Qualifications:
Skills Requirements:
Co-Monitoring, 3 Years Experience in Pharma, Query Tracking, Master Study File Reconciliation, Regulatory Document Review, CRF Review and sign-off, BS in Life SciencesContact Information
Contact:Beckman,Ryan
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