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Associate, Clinical Trial Management in Irvine, CA at APEX Systems

Date Posted: 4/16/2019

Job Snapshot

Job Description

Job #:  960544

Position Summary: 
The Associate, Clinical Trial Management will support the Clinical Trial Manager in ensuring the assigned clinical studies are run on time and to budget and are completed in compliance with all relevant laws, regulations, and regulatory guidelines as well as all policies and procedures.

This position is located in Irvine, CA based but may have option to work from home 2 days per week
Responsibilities: 
• Regional site feasibility, when necessary 
• Tracking of site training, certification, 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, and 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 
• Regional trial master file management (TMF): ensure all documents are appropriately filed in the TMF 
• Regional enrollment management: site activation and enrollment tracking for monthly reporting 
Qualifications: 
• Bachelor’s degree or higher 
• Science degree preferably in science or health-related field 
• Previous experience of working on a clinical study 
• 3+ years relevant experience at pharmaceutical CRO or sponsor 
• Experience supporting clinical trials 
• Handle and prioritize multiple tasks simultaneously 
• Work effectively in a team/matrix environment 
• Understand technical, scientific and medical information 
• Handle conflict management and resolution 
• Familiarity with clinical study budgets and accruals 

 

 

 

 

 

 

 

 

 

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 844-463-6178