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Scientific Coordinator - United States  

Company managed [?] Still accepting applications
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Posted on : 29 May 2017

Project Description

BASIC SUMMARY:  
  • Provide protocol and report support to study directors, and assist with providing information/data requested by sponsors. 
  • Assist with management of QA audits and assure necessary corrections and follow-up take place.



ESSENTIAL DUTIES AND RESPONSIBILITIES:  
  • Attend post-award and/or pre-study meetings and monitor events during the in-life phase to assure a full understanding of assigned projects and results, including objectives, timelines and reporting requirements. 
  • Create/customize planning tools to facilitate prioritization of daily activities.
  • Interact regularly with sponsors: send amendments and regulatory forms for signature, respond to sponsor-requests for information and tables, and assist with sponsor on-site visits.  Serve as primary point of contact to the sponsor when study director is not available.
  • With guidance, write initial protocol drafts. Upon study director approval, distribute draft protocols for internal and/or sponsor review, and coordinate amendment/revision process.
  • Facilitate signature/approval process for protocol, amendments and other required forms.
  • Tabulate study data and schedule data review meetings.  
  • Create/generate special tables for sponsors as needed.
  • Assemble report (text and data tables) for senior scientific review, QA audits, and final report compilation.  
  • Assist with management of QA audits and assure necessary corrections and follow-up take place.
  • Ensure that all study books are corrected appropriately, and that documentation is GLP-compliant prior to submission to QA. 
  • Assist in IACUC form preparation and perform IACUC literature searches. 
  • Assist in documentation of deviations from the protocol or Standard Operating Procedures (SOP).  Assist in drafting new or study specific SOPs.
  • Perform all other related duties as assigned.



Qualifications
Education:  Bachelor’s degree (B.A. /B.S.) or equivalent in science or related discipline. 
Experience:  2-4 year related experience in a laboratory or scientific research environment. 
An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Certification/Licensure:  None.
Other:  
  • This position requires analytical thinking skills and a good understanding of scientific processes. 
  • Strong organizational skills and attention to detail required, as are computer skills including MS Office software and database management. 
  • Must be familiar with medical terminology and have a thorough understanding of technical aspects of research studies (e.g. observing dosing, treatments, surgical procedures, and necropsy evaluations). 



Equal Employment Opportunity
Our company is an Equal Opportunity Employer M/F/Disabled/Vet