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 Senior Clinical Records Representative , you will be responsible for the accuracy and completeness of our clinical study documents. The position will be on-site at our Irvine headquarter 5 days/week.How you will make an impact:
Review and ensure accuracy and completeness of clinical study documents (e.g., EFS, pivotal) ensuring GDP and performing quality checks with limited supervision
Organize and archive documents and data in eTMF (electronic trial master file) and/or CTMS (clinical trial management system) ensuring compliance with internal procedures and regulatory guidelines
Perform quality checks and escalate issues or remediations to management
Provide training and knowledge transfer to team members
Review clinical data for completeness of study files
Retrieve documents in support of internal and external audits utilizing knowledge of eTMF filing structure
Other incidental duties: May oversee vendor study training (e.g., CRO, Echo Core Lab, DSMB/CEC). Collate new study materials, create study binders, patient recruitment materials, and arrange shipment of materials to clinical sites
What you will need (required):
High School Diploma or equivalent
4 years of previous related experience in regulatory documentation for clinical studies
What else we look for (preferred):
Bachelor’s Degree in related field
Additional skills:
Good computer skills including MS Office Suite, Adobe, and ability to operate general office machinery
Experience with TMF preferred
Good written and verbal communication skills and interpersonal relationship skills
Good problem-solving and critical thinking skills
Full knowledge and understanding of Edwards policies, SOPs, domestic medical device regulatory guidelines relevant to clinical study documentation
Good knowledge of EW GDP (Good Document Practice) SOP requirements with the ability to provide feedback to authors and approvers on deficiencies
Strict attention to detail
Ability to manage confidential information with discretion
Ability to interact professionally with all team organizational levels
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
For California, the base pay range for this position is $58,000 to $80,000 (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.