Clinical Trial Associate

Allentown, PA 18104

Posted: 05/22/2019 Industry: Other Area(s) Job Number: 6527

McGrath Systems is accepting applications for a Clinical Trial Associate to work in the Allentown, PA area.

Responsibilities: 
  • Assist with the execution of clinical studies such as coordinating, monitoring and oversight to ensure compliance with study protocols, SOPs, ICH-GCP guidelines 
  • Develop clinical study documents such as study protocols, data collection forms, informed consent forms, monitoring plans, clinical study reports, and any other study related documents.     
  • Conduct pre-study, initiation, interim, and close-out site visits and complete trip reports and follow up letters in a timely manner.
  • Design and provide training to investigators and coordinators during initiation visits.  
  • Review clinical data for completeness and accuracy. 
  • Database creation (excel), database entry and limited analysis of clinical data for analytical and clinical studies.      
  • Set up and maintenance of Trial Master File.
  • Assists with generation of clinical portions of regulatory submission documents 
  • Prepares for and participates in inspections by FDA, Notified Bodies and other regulatory agencies.
  • Provide information and status updates to the clinical trials manager and core team members.      

Requirements: 
  • BS in scientific related field
  • 2+ years of field monitoring experience as a CRA 
  • Knowledge of Code of Federal Regulations, Good Clinical Practices, and FDA guidelines pertaining to medical devices and biologics.   
  • Knowledge of EU Medical Device and In Vitro Diagnostics Regulations. 
  • Outstanding organizational and time-management skills such as prioritizing/organizing to meet deadlines of multiple projects with overlapping deliverables. 
  • Ability to effectively communicate orally and in writing at all corporate levels (subordinates, peers, executive management) as well as outside the company.
  • Advanced PC Skills (Microsoft Word, Excel and Power Point)
  • Ability to travel up to 40% over the year 

McGrath Systems is an Equal Opportunity Employer and embraces diversity in the workplace.

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