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Representative, Clinical Research - THV

Company: Edwards Lifesciences
Location: Irvine
Posted on: October 15, 2020

Job Description:

This is a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing solutions for patients suffering from structural heart disease. The Clinical Research Representative will be responsible for efficient processing and quality check of all study documents.

Key Responsibilities:

• Review and ensure accuracy and completeness of clinical study files

• Organize documents and data in ETMF (electronic trial master file), CTMS (clinical trial management system) and ensure compliance with internal procedures. May review clinical data for completeness for multiple clinical research trials

• Collate new study materials, create study binders, patient recruitment materials, and arrange shipment of materials to clinical sites

• Other incidental duties

Education and Experience:

H.S. Diploma or equivalent 2 years experience of previous related experience Required

Bachelor's Degree Preferred

Additional Skills:

• Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery

• Experience with Clinical Systems such as eTMF (electronic Trial Master File) and CTMS (Clinical Trial Management System) preferred.

• Good written and verbal communication skills and interpersonal relationship skills

• Ability to work in a fast paced environment

• Knowledge and understanding of Edwards policies and SOP, and domestic medical device regulatory guidelines relevant to clinical study documentation

• Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint

• Good written and verbal communications skills

• Good problem-solving skills

• Ability to manage confidential information with discretion

• Strict attention to detail

• Ability to interact professionally with all organizational levels

• Contacts are across the organization, and may include external contacts

• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. SDL2017

Keywords: Edwards Lifesciences, Irvine , Representative, Clinical Research - THV, Other , Irvine, California

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