Senior Clinical Research Associate

Description

• Independently responsible for all activities of the clinical trial including clinical site selection, study initiation visits, training of on-site personnel, study close-out visits and trial monitoring with on-site audits of clinical data for accuracy and completeness, and clinical report preparation and presentation.
  
  
• Devise and write study protocols, investigator manuals, site specific instruction manuals and design case report forms for new and modified products.
  
  
• Prepare clinical reports and clinical/non-clinical sections of regulatory submissions and prepare scientific abstracts, posters and publications arising from the trials.
  
  
• Assist with the management of key study parameters (i.e. start-up activities, enrollment, data collection, etc.)
  
  
• Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem.
  
  
• Maintain a high level of familiarity with clinical literature in field of study and related areas and stay up to date on major advances in infectious disease diagnosis and cancer detection and the use of new tests and advances in clinical practice.
  
  

• In Vitro Diagnostic (IVD) products experience in molecular diagnostics or immunodiagnostics; HIV and/or Hepatitis experience is a plus
  
  
• Bachelor's degree in a scientific discipline, RN or BSN degree or equivalent.
  
  
• Minimum of 5 to 8 years experience with monitoring IVD products.
  
  

• Good understanding of medical terminology, human physiology and laboratory testing
  
  
• Experience with laboratory automation and biological databases
  
  
• Knowledge of GCP & ICH guidelines and FDA regulations
  
  
• Travel requirements of 20-40%