Senior Clinical Research Associate (Senior Specialist) - Hybrid In House/Monitor - TMTT

  • Edwards Lifesciences
  • Irvine, CA, USA
  • Jul 20, 2020
Full time Health Care

Job Description

This is a unique opportunity to join an early-stage product development group, Transcatheter Mitral & Tricuspid Therapies (TMTT), focused on developing solutions for patients suffering from structural heart disease.

The Senior Specialist, Clinical Research Associate will ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements. This role is a hybrid Senior CRA responsible for mentoring in house clinical research associates in Irvine, Ca and having 40% travel to field sites nationwide.
 

Job Functions:

  • Responsible for study start-up and study conduct activities including drafting ICF study specific template and TMF plan, approving study specific essential documents list, managing and communicating the status of study progress and activities
  • Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution. Oversee the work of the Sr Representative and may provide coaching and training to lower level employees
  • Lead in the investigation of all discrepancies in study documentation, by applying clinical protocol knowledge and GCP and develop processes to mitigate reoccurrence throughout study phases
  • Lead in assessing current and new processes, identifying opportunities and implementing solutions to improve process efficiency within and across related functional areas
  • Conduct in-house and site (if applicable) reviews of associated documentation and lead in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure documents are compliant with Good Documentation Practices and Edwards internal SOPs, and US and OUS regulations
  • Partner with clinical project manager in leading regular team meetings
  • Prepare materials for steering and investigator meetings
  • Other incidental duties

  • Travel may be up to 40% nationwide as needed
     

Minimum Qualifications:

  • Bachelor's Degree in related field required
  • 5 years of previous experience with regulatory documentation for clinical studies required
  • Ability to travel up to 40% nationwide as needed

Preferred Qualifications:  

  • Proven expertise in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file)

Additional Skills and Responsibilities:

  • Written and verbal communication skills and interpersonal relationship skills
  • Excellent problem-solving and critical thinking skills
  • knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
  • Full 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 key contact representing the organization on contracts or projects
  • Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
  • 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.