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.Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.The Associate Clinical Research Specialist will ensure clinical trials are conducted and reported 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:
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, the base pay range for this position is $66,000 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.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.COVID Vaccination RequirementEdwards 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.