Senior Clinical Research Representative - Transcatheter Mitral & Tricuspid Therapies

Edwards Lifesciences Corp Irvine , CA 92606

Posted 4 months ago

As the Sr. Clinical Research Rep will be joining a fast and dynamic team, supporting the Clinical Development team within Transcatheter Mitral and Tricuspid Therapies (TMTT) department. They will be supporting multiple clinical trials ranging from early feasibility to pivotal. Their main responsibilities will be managing clinical study documentation, medical imaging files, and coordinating training for external partners.

Job Functions:

  • Organize documents and data in screening tracking system, ETMF (electronic trial master file), CTMS (clinical trial management system) and ensure compliance with internal procedures. Perform quality checks and escalate issues or remediations within team. Review clinical data for completeness for multiple clinical research trials

  • Maintain and update trackers for incoming documents and images and check for compliance to the clinical protocol and internal processes

  • Review and ensure accuracy and completeness of clinical study files and perform quality checks

  • Coordinate web based training with external physicians

  • Create training documents for internal and external participants as needed to support clinical trials

  • Contribute to internal and external audits as requested

  • Assist with query management, escalate issues appropriately for resolution

  • Participate in work streams for continuous improvements

  • Full knowledge and understanding of Edwards policies, SOPs, domestic medical device regulatory guidelines relevant to clinical study documentation

  • Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint

  • Excellent written and verbal communications skills

  • Advanced problem-solving skills

  • Ability to manage confidential information with discretion

  • Completes tasks in resourceful and effective ways

  • 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

  • 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 assigne

  • ments

  • Contributes to sections of organizational projects and goals

  • Errors in judgment may require some expenditures of resources to rectify

  • Contacts are within and outside of the organization

  • Must be able to work in a team environment, including immediate supervisor and other team members in the section or group

  • Ability to build productive internal/external working relationships

  • Participates in basic process improvements.

#LI-PF1

#AS

Requirements/Education:

  • Bachelor's Degree in related field with 1 year of previous work experience Required

  • 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

  • Good written and verbal communication skills and interpersonal relationship skills

  • Developing problem-solving and critical thinking skills

  • Other incidental duties

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Senior Clinical Research Representative - Transcatheter Mitral & Tricuspid Therapies

Edwards Lifesciences Corp