Specialist, Clinical Research

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

Job summary

Edwards Lifesciences Irvine is seeking a Clinical Research Professional to support TMF audits, regulatory compliance, and cross-functional collaboration. The role focuses on site reviews, data integrity, and process improvement across clinical operations.

Requirements include a Life Sciences or Nursing degree with 3 years of clinical research experience and proficiency with electronic data capture systems. CA-based and visibility into regulatory standards are key."

Qualifications

• Bachelor's Degree in Life Sciences or Nursing with 3 years of clinical research experience including QA/regulatory compliance.
• Experience in electronic data capture.

Responsibilities

• Conduct in-house and site reviews of documentation and participate in audits to ensure TMF regulatory compliance.
• Assess current processes and propose efficiency improvements across functional areas.
• Partner with cross-functional teams for data reviews, query management, and discrepancy investigations.
• Identify and investigate discrepancies in study documentation and develop mitigation processes.

Skills

Clinical research experience

Electronic data capture

Regulatory compliance knowledge

Strong communication skills

Education

Bachelor's Degree in Life Sciences or Nursing

Tools

EDC

CTMS

eTMF

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 activities
• Experience 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.

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).

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. Through breakthrough technologies, world-class evidence and partnerships with clinicians and healthcare stakeholders, our employees are inspired by our patient-focused culture to deliver life-changing innovations to those who need them most.