Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open-heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

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.

We are searching for a Senior Clinical Research Specialist to join Edwards. As the Senior Clinical Research Specialist, you will ensure trials are conducted in accordance with all applicable regulatory requirements. This is an in-office role, 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.

• Manage sites through all phases of study conduct including regulatory document collection, training maintenance, and execution support.

• 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.)

• Participate in cross-BU working groups representing Surgical Clinical affairs

• Other incidental duties

What you'll need (Required):

• Bachelor's Degree in related field

• 5 years of experience with regulatory documentation and managing sites and third-party vendors for clinical studies

• Experience in clinical site monitoring, site qualification, and site training

• Ability to travel up to 10% for clinical site visits, conferences, etc

• Covid Vaccination

What else we look for (Preferred):

• Experience managing clinical trials within medical device industry

• Prior clinical research experience with Class III Medical Devices including PMA, IDE and 510(k)

• Clinical Research Monitoring Experience

• Sponsor-related experience executing an IDE or pre-market study from site selection and study startup, through execution and close out

• Experience in Surgical therapies/medical device product

• Knowledge of cardiovascular physiology and structural heart anatomy

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, the base pay range for this position is $103,000 to $140,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will accepted while this position is posted on our Career website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.