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Clinical Research Associate (Specialist) - In House Irvine - Transcatheter Mitral and Tricuspid Ther

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

Job Description:

Ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements

Key Responsibilities:

• Perform study start-up and conduct activities including ICF review that meets regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities

• Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases

• Conduct in-house and site (if applicable) reviews of associated documentation and participate in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards internal SOPs, and US and OUS regulations

• Assess current processes, identify opportunities and propose solutions to improve process efficiency within and across related functional areas

• Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution

• Assist with clinicaltrials.gov updates

• Other incidental duties

Education and Experience:

Bachelor's Degree in in related field, 3 years years experience of previous experience with regulatory documentation for clinical studies Required

Additional Skills:

• Good computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file) preferred

• Excellent written and verbal communication skills and interpersonal relationship skills

• Excellent problem-solving and critical thinking skills

• Solid knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols

• Solid understanding of regulatory submissions, reporting, and audits

• Ability to manage confidential information with discretion

• Strict attention to detail

• Ability to interact professionally with all organizational levels

• Ability to manage competing priorities in a fast paced environment

• Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects

• Ability to build productive internal/external working relationships

• 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 , Clinical Research Associate (Specialist) - In House Irvine - Transcatheter Mitral and Tricuspid Ther, Other , Irvine, California

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