Clinical Research Specialist

Edwards Lifesciences • Irvine, CA

17d • $87,000 - $123,000

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. How you will make an impact: Performing study start-up and conducting activities including ICF review that meets regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities. Identifying and investigating discrepancies in study documentation by applying clinical protocol and GCP knowledge and developing processes to mitigate reoccurrence throughout study phases. Conducting in-house and site (if applicable) reviews of associated documentation and participate in 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. Assessing current processes, identifying opportunities and proposing solutions to improve process efficiency within and across related functional areas. Partnering with cross-functional teams (e.g., clinical data management, field teams) with query management, data reviews and resolution.

Requirements

• Bachelor's Degree in Life Sciences or Nursing with 3 years of experience in clinical research (site management, clinical project management, monitoring, and/or CRC) including quality assurance/control and regulatory compliance or field monitoring with experience in the healthcare industry or equivalent work experience based on Edwards criteria
• Experience in electronic data capture

Nice To Haves

• Experience working in a medical device or regulated industry
• Good computer skills in usage of MS Office Suite and Clinical Systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file)
• Strong written and verbal communication skills, presentation skills, interpersonal relationship skills, and analytical skills
• Strong problem-solving and critical thinking skills
• Strong understanding of cardiovascular anatomy, pathology and physiology or Business Unit area of expertise
• Moderate knowledge and understanding of Edwards policies, procedures, and international and domestic medical device regulatory guidelines relevant to clinical protocols
• Moderate 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 inter-departmental teams and representing the organization on specific projects
• Ability to build productive internal/external working relationships

Responsibilities

• Performing study start-up and conducting activities including ICF review that meets regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities.
• Identifying and investigating discrepancies in study documentation by applying clinical protocol and GCP knowledge and developing processes to mitigate reoccurrence throughout study phases.
• Conducting in-house and site (if applicable) reviews of associated documentation and participate in 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.
• Assessing current processes, identifying opportunities and proposing solutions to improve process efficiency within and across related functional areas.
• Partnering with cross-functional teams (e.g., clinical data management, field teams) with query management, data reviews and resolution.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level