Clinical Research Specialist - Cardio Trials & Compliance

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

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."