Associate Clinical Research Specialist

Edwards Lifesciences

402d • $66,000 - $90,000 • Hybrid

About The Position

The Associate Clinical Research Specialist plays a crucial role in ensuring that clinical trials are conducted in compliance with regulatory requirements. This position involves collaboration with various stakeholders, including principal investigators and regulatory authorities, to generate clinical evidence that demonstrates the effectiveness and safety of innovative medical technologies. The role is hybrid, requiring the candidate to reside near the Irvine Corporate location for necessary onsite days.

Requirements

• Bachelor's Degree in Life Sciences or Nursing
• 1-year relative work experience in clinical research (as a CRC or CRA) including quality assurance/control and regulatory compliance in the healthcare industry
• Covid vaccination is required.

Nice To Haves

• Experience managing clinical trials within the medical device industry
• Knowledge of cardiovascular physiology and structural heart anatomy
• Good computer skills in MS Office Suite and Clinical Systems such as CTMS and eTMF
• Experience with electronic data capture
• Good written and verbal communication skills and interpersonal relationship skills
• Good problem-solving and critical thinking skills
• Understanding of regulatory submissions, reporting, and audits.

Responsibilities

• Participate in study start-up activities, including tracking site readiness and communicating with clinical trial sites about planning and logistics.
• Conduct reviews of documentation for internal and competent authority audits to ensure compliance with Good Documentation Practices and regulations.
• Investigate discrepancies and help develop processes to minimize recurrence during study conduct and closeout.
• Assist in identifying opportunities and proposing solutions to improve process efficiency within related functional areas.
• Perform other incidental duties as required.

Benefits

• Competitive salaries
• Performance-based incentives
• Wide variety of benefits programs to address diverse individual needs of employees and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Miscellaneous Manufacturing
• Education Level: Bachelor's degree