Clinical Records Associate Specialist, Transcatheter Heart Valve

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 under-treated. 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.
As a Clinical Records Associate Specialist, you will be responsible for assessing Trial Master File (TMF) issues and execute process improvements within Clinical Records.
The position will be on-site at our Irvine headquarter 5 days/week and will turn to a hybrid working schedule after the completion of the first 3 months at the discretion of the leadership team.
How you will make an impact:

• Identify opportunities and propose solutions to improve process efficiency within and across related functional areas (e.g, trial workflow timelines, TMF essential documents) Develop and contribute to the creation/harmonization of templates/guidance (e.g. document tracking tools, training materials, TMF Work Instructions)
• Identify and assess TMF issues and/or discrepancies discovered during review and collaborate with appropriate team members to bring to resolution
• 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. Play a vital cross-functional role in TMF document retrieval and management
• Determine root cause and recommend corrective actions on basic issues
• Provide training and knowledge transfer to team members
• Other incidental duties

What you will need (required):

• Bachelor's degree AND 1 year of previous related experience with regulatory documentation for clinical studies from a sponsor/CRO
• Experience with eTMF (electronic Trial Master File)

What else we look for (preferred):

• Experience with ERP software, JDE, CTMS (Clinical Trial Management System) and eTMF (electronic Trial Master File)

Additional skills:

• Good computer skills in usage of MS Office Suite
• 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 knowledge of EW GDP (Global Document Practice) SOP requirements with the ability to train team members on standards and applications
• 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 $55,000 to $78,000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience).
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
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.