Senior Clinical Records Representative
About The Position
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. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. As the Senior Clinical Records Representative, you will play a key role in ensuring the accuracy, completeness, and proper management of documentation supporting our clinical studies. You will be responsible for performing quality checks on all study documents and maintaining study‑specific training matrices and rosters. This is a hybrid position combining remote work with onsite collaboration. The selected candidate must live within a reasonable commuting distance of our Irvine Corporate location and be available for required onsite days.
Requirements
- High school diploma or equivalent, with 4 years of related work experience
- Ability to travel up to 10% for occasional business needs
Nice To Haves
- Bachelor’s Degree in related field.
- Experience in preparing and managing regulatory documentation for clinical studies, ensuring compliance with applicable guidelines and protocols.
- Good computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file).
- Good written and verbal communication skills and interpersonal relationship skills.
- Developing problem-solving and critical thinking skills.
- Full knowledge and understanding of Edwards policies, SOPs, domestic medical device regulatory guidelines relevant to clinical study documentation.
- Advanced proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint.
- Strict attention to detail.
- Ability to manage confidential information with discretion.
- Ability to interact professionally with all 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.
Responsibilities
- Review and ensure accuracy and completeness of clinical study documents (e.g., EFS, pivotal) ensuring GDP and performing quality checks with limited supervision.
- Escalate quality check issues or remediations, including development and communications of quality reports, with cross functional teams and/or subject matter experts.
- Provide training and knowledge transfer to teammates.
- Participate in workstreams for continuous improvements.
- Contribute to internal and external audits as requested.
- Other incidental duties.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
