Job description

Associate Clinical Research Specialist (Irvine) - Transcatheter Heart Valve (THV)

Edwards has a unique opportunity to join the Transcatheter Heart Valve (THV) group, focused on developing solutions for patients suffering from structural heart disease. The Associate Clinical Research Specialist, will ensure clinical trials are conducted and reported in accordance with all applicable regulatory requirements. T his position is located at our Irvine headquarters, there will be at least four days working in the office.

Key Responsibilities:

• 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

Minimum Education and Experience:
Bachelor's Degree in related field, required

1 year of previous experience with clinical research regulatory documentation for clinical studies, required

Covid vaccination, required

Additional Skills:

• 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.
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving and critical thinking skills
• Good knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
• Good 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 immediate supervisor and other team members in the section or group
• Ability to build productive internal/external working relationships
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

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$64,000 to $91,000 (highly experienced).

The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).

About Edwards Lifesciences

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world’s leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

For us, helping patients is not a slogan - it’s our life’s work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

COVID Vaccination Requirement

Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all Healthcare Interacting positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who interact with healthcare providers as part of their role. If hired, as a condition of employment, you will be required to submit proof that you have been fully 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 countries where it is prohibited by law to impose vaccination. In countries where vaccines are less available, or other requirements exist, we may institute alternate measures that optimize patient safety and healthcare provider safety, which may include regular COVID testing or specific masking requirements.

For United States Applicants Only:
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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