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 Associate 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:

• Participate in study start-up activities (e.g., tracking site readiness, communication with clinical trial sites about planning and logistics of site qualification visit and site initiation visit)

• Conduct reviews of documentation needed for 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

• Investigate discrepancies and participate in the development of processes to minimize possibility of recurrence during study conduct and closeout

• Assist in identifying opportunities and proposing solutions to improve process efficiency within and across related functional areas

• Other incidental duties

What you'll need (Required):

• Bachelor's Degree in Life Sciences or Nursing

• 1-year relative work experience in clinical research (as a CRC or CRA) including quality assurance/control and regulatory compliance with experience in the healthcare industry

• Covid vaccination

What else we look for (Preferred):

• Experience managing clinical trials within medical device industry

• Knowledge of cardiovascular physiology and structural heart anatomy

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

• Experience with electronic data capture

• Good written and verbal communication skills and interpersonal relationship skills

• Good problem-solving and critical thinking skills

• Understanding of regulatory submissions, reporting, and audits

Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.

For California (CA), the base pay range for this position is $67,000 to $90,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).  Applications will be accepted while this position is posted on our Careers website.