Sr. Associate, Clinical Trial Management - CA in Irvine, CA at Apex Life Sciences

Date Posted: 5/15/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Irvine, CA
  • Job Type:
    Management
  • Experience:
    Not Specified
  • Date Posted:
    5/15/2018
  • Job ID:
    849313

Job Description


Position Summary: 

  • The Sr ACTM will support CTM/OSL in ensuring the assigned clinical study(ies) are run to time and budget and are completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all policies and procedures. 

Experience: 

  • The incumbent will assist CTM/OSL with: 
    • Regional study feasibility when necessary 
    • Tracking of site training, certification(s), delivery of ancillary supplies, etc., necessary for site activation 
    • Development of study-specific documents when necessary 
    • Regional vendor management: manage vendor issues, coordinate contract amendments, create monthly vendor accruals, process and track monthly invoices, provide quarterly budget forecast assumptions 
    • Periodic review of protocol deviations 
    • Database lock activities (interim or final lock) 
    • Regional study drug management: track shipping or storage site temperature excursions and coordinate new shipment requests if necessary 
    • Regional trial master file management: ensure all documents are filed in the TMF appropriately during periodic reviews and at database lock 
    • Regional enrollment management: site activation and enrollment tracking for monthly reporting 

Qualifications / Experience: 

  • B.A/B.S. in science or health-related field 
  • Four (4) years clinical research experience or related experience 
  • Monitoring experience is preferred

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.