Clinical Research Specialist - Cardio Trials & TMF

Edwards Lifesciences; Irvine, Northern (CA, KY); Hybrid; USD 87,000 - 123,000; Full time

Job summary

Edwards Lifesciences in Irvine, CA, is seeking a Clinical Affairs professional to drive evidence generation, TMF compliance, and regulatory alignment across audits and inspections.

You will partner with investigators and cross-functional teams to improve processes, manage site activities, and ensure data quality in ICH-GCP settings.

This role requires a life sciences or nursing degree with experience in clinical research and EDC, CTMS, and eTMF systems.

Qualifications

• Bachelor's degree in Life Sciences or Nursing with 3 years clinical research experience including QA/QC and regulatory compliance.

Responsibilities

• Review TMF documents and participate in audits to ensure compliance with GCP, Edwards SOPs, and US/OUS regulations.
• Assess processes and propose improvements to increase cross-functional efficiency.
• Collaborate with clinical data management and field teams on query management and data reviews.
• Identify discrepancies in study documentation and develop mitigation processes.

Skills

Electronic data capture

GCP knowledge

Regulatory compliance

Cross-functional collaboration

Data review

Problem solving

Education

Bachelor's degree in Life Sciences

Bachelor's degree in Nursing

Tools

EDC

CTMS

eTMF

Job description

Edwards Lifesciences in Irvine, CA, is seeking a Clinical Affairs professional to drive evidence generation, TMF compliance, and regulatory alignment across audits and inspections.

You will partner with investigators and cross-functional teams to improve processes, manage site activities, and ensure data quality in ICH-GCP settings.

This role requires a life sciences or nursing degree with experience in clinical research and EDC, CTMS, and eTMF systems.