Clinical Research Specialist

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 in-house 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 will make an impact:  

• 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

• Other incidental duties assigned by Leadership

What you'll need (Required):

• Bachelor's Degree or equivalent in Life Sciences or Nursing

• 3 years of work experience in clinical research (site management, clinical project management, field monitoring, and/or clinical research coordination) including quality assurance/control and regulatory compliance or field monitoring with experience in the healthcare industry

• Experience in electronic data capture

• Covid vaccination

• Ability to travel up 25%

What else we look for (Preferred):

• Previous medical device Clinical Research experience in cardiology

• Clinical research certification (ACRP or SOCRA, Clinical Coordinator/CRA certification)

• Hands-on experience in supporting PMA submission preparation and data cleaning, assisting with clinical trial documentation, ensuring regulatory compliance, and maintaining data integrity.

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

• Strong written and verbal communication skills, presentation skills, interpersonal relationship skills, and analytical skills

• Strong problem-solving and critical thinking skills

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

• Moderate 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

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to