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Clinical Operations Representative
Ref No.: 18-14410
Location: Irvine, California
Title - Clinical Operations Representative, Clinical Affairs
Location - Irvine CA.
​Duration - 02+ Months

Clinical Operations Representative, Clinical Affairs – Heart Valve Therapy (HVT)

Description
 
A pioneer in the development and commercialization of heart valve therapies, the world's leading manufacturer of heart valve systems and repair products. This contract in-house position is located in Irvine, CA.
 
The Clinical Operations Representative is responsible for efficient processing and quality check of all study documents, vendor/site payments, and assistance with various clinical study management activities.
 
Job Functions:
  • Review and ensure accuracy and completeness of clinical study files, enter into computerized tracking system, and file/scan for archive, for multiple clinical research trials
  • Conduct periodic audits of documentation and may participate in internal master file audits
  • Assist with reviewing and processing of clinical site and vendor payments 
  • Assist with site and patient binder creation and other study supplies
  • Data review and other incidental clinical study management duties
Qualifications
 
Required Education/Skills/Experience: 
  • HS Diploma or equivalent plus 4 years of related experience required
  • Bachelor's Degree preferred
Additional Talents and General Expectations: 
  • Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery
  • Experience with an Trial Master File (TMF) software such as Veeva, CTMS (Clinical Trial Management System), etc. preferred
  • Excellent written, verbal communication and interpersonal skills
  • Ability to work in a fast-paced environment
  • Demonstrated problem-solving and critical thinking skills
  • Full knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical study documentation
  • Ability to manage confidential information with discretion
  • Completes tasks in resourceful, effective and timely manner
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Must be able to work in a team environment, including inter-departmental teams, with supervisory guidance provided as needed in the execution of routine tasks
  • General instructions given with assignment of new lines of work or complex special assignments