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SR. Clinical Operations Associate

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Location
Irvine, CA
Hourly
$51.53 - $71.88
Job Type
Contract
Degree
Master of Science
Date
May 24, 2017
Job ID
2485858
Our pharma client needs two Sr.Clinical Operations Associates for a one-year contract. They will work with the Clinical Trial Manager and Operations Study Lead in the operational execution of assigned clinical studies.

Requirements
  • Science degree preferably in science or health-related field 
  • Previous experience of working on a clinical study 
  • Good Clinical Practices, ICH guidelines, PhRMA code, CFR Guidelines, clinical research ethics, HIPAA and patient privacy laws (plus applicable local regulations, when country-based)
Responsibilities
Study Management/Conduct Phase 

The incumbent assists the CTM/OSL in: CRO oversight, database lock activities; regional study drug management; regional trial master file management; periodic review of protocol deviations; regional vendor management; and ensuring adverse event reporting. 

Close-Out Phase 
  • The incumbent assists the CTM/OSL in the following activities: supporting database lock activities; ensuring all regional documents are filed in the TMF appropriately; ensuring all close-out activities are completed; ensuring study documentation is properly archived when the study is considered completed. 
  • The employee is expected to complete their assigned tasks within agreed upon project priorities, timelines and quality specifications. 
  • The incumbent ensures the assigned clinical study is run to time and budget and is completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all policies and procedures. 
  • The incumbent is responsible for completing all required training to execute their job and maintain their training records. 
  • They are responsible for reporting any potential GCP violations either internally or externally to their manager and participate in any corrective and preventative action plans as appropriate. 
  • They are responsible for reporting any safety concerns to the appropriate department including but not limited to Serious Adverse Events. 
  • In addition, the employee is responsible for documenting key communications from either internal or external sources in the study file.