Senior Specialist, Clinical Research

Imagine how your ideas and expertise can change a patient’s life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients’ lives. As part of our Clinical Affairs team, you’ll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes.

Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

As the Senior Clinical Research Specialist, you will ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements. This is a hybrid role (office and remote blend). Selected candidate must reside within a reasonable distance from the Irvine Corporate location and have ability to commute on required onsite days.

How you'll make an impact:

• Responsible for study start-up and study conduct activities including ICF review, developing study specific templates and TMF plan, approving and managing study specific essential documents, managing and communicating the status of study progress and activities, and driving resolution of issues encountered with sites during all phases of the study.
• Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution.
• Lead the investigation of all discrepancies identified in study documentation reconciliation by applying clinical protocol requirements, GCP knowledge, Edwards SOPs, and appropriate regulations and guidance; develop and implement processes to mitigate reoccurrence of issues throughout the study.
• Lead in assessing current and new processes, identifying 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.
• Provide coaching and knowledge transfer to team members
• Prepare materials for meetings (Steering Committee, Investigators, etc.)
• Other incidental duties

What you'll need (Required):

• Bachelor's Degree or Equivalent in related field
• 5 years of experience in clinical research (site management, site qualification, site training, clinical project management, monitoring, and/or CRC) including quality assurance/control and regulatory compliance or field monitoring with experience in the healthcare industry

What else we look for (Preferred):

• Experience in cardiac research or medical device trial
• Clinical research experience from a sponsor
• Experience in electronic data capture
• Covid Vaccination
• Ability to travel nationwide up to 10% for site visits, and conferences
• 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
• Strong written and verbal communication skills, presentation skills, interpersonal relationship skills, and analytical skills are required
• Strong problem-solving and critical thinking skills
• Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
• Moderate understanding of regulatory submissions, reporting, and audits
• Ability to manage confidential information with discretion
• 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

Aligning our overall business objectives with performance, we of