Specialist, Clinical Research

Edwards Lifesciences; Irvine (CA); On-site; USD 87,000 - 123,000; Full time

Benefits offered by this job

Competitive salaries

Performance-based incentives

Benefits programs

Job summary

Edwards Lifesciences in California is seeking a Clinical Research professional to support TMF management and regulatory compliance within the Transcatheter Mitral and Tricuspid Therapies unit. You will collaborate with investigators, clinical teams, and auditors to ensure high-quality documentation and compliant trial conduct.

The role emphasizes data integrity, audits, site management, and cross-functional collaboration, with a focus on improving processes and patient outcomes.

Qualifications

• Bachelor's degree in Life Sciences or Nursing with 3 years in clinical research
• Experience in site management, monitoring, or CRC roles
• Experience with electronic data capture (EDC) systems

Responsibilities

• Review TMF documents for compliance with Good Documentation Practices and regulations
• Identify process improvements to increase efficiency across functions
• Collaborate with cross-functional teams for data reviews and query resolution
• Investigate study documentation discrepancies and mitigate recurrence

Skills

Clinical research

Site management

Regulatory compliance

GCP knowledge

EDC

Data review

Communication

Education

Bachelor's degree in Life Sciences or Nursing

Tools

EDC systems

CTMS

eTMF platforms

Job description

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:

• 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.
• Identifying and investigating discrepancies in study documentation by applying clinical protocol and GCP knowledge and developing processes to mitigate reoccurrence throughout study phases.

What you’ll need (Required):

• 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

What else we look for (Preferred):

• Medical device clinical trial experience
• Cardiovascular or structural heart clinical research experience
• Experience supporting audits and inspections
• Experience working as a Clinical Research Coordinator (CRC) at an investigational site
• Experience working for a Sponsor and/or CRO supporting clinical trial operations (such as a CRA or IHCRA)
• Experience supporting site management, study conduct, data review, regulatory documentation, and/or study closeout activitiesExperience working with electronic clinical systems including EDC, CTMS, and/or eTMF platforms
• Strong knowledge of ICH-GCP, FDA regulations, and clinical research best practices
• Demonstrated ability to build productive relationships with investigators, CRCs, and site personnel
• Excellent organizational skills with the ability to manage multiple sites, priorities, and deadlines simultaneously
• Strong problem-solving, critical thinking, and risk assessment skills
• Ability to independently drive issue resolution and follow-through
• Strong written, verbal, and presentation skills
• Experience reviewing and maintaining high-quality regulatory and TMF documentation.

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 (CA), the base pay range for this position is $87,000 to $123,000 (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.