Clinical Trials Data & Compliance Associate

Edwards; Irvine (CA); On-site; USD 59,000 - 83,000; Full time

Job summary

Edwards in Irvine, CA is seeking a Clinical Trial Coordinator with a Bachelor's degree and 1 year of trial management experience. You will partner with sites, clinical teams, and regulatory bodies to ensure device accountability data is accurate and timely.

Key responsibilities include training teams on trial processes, resolving data discrepancies, and contributing to regulatory submissions while maintaining strict compliance and high-quality data integrity.

Qualifications

• Bachelor’s degree in related field is required with 1 year of clinical trial management experience or equivalent.
• Experience with ERP JD Edwards, Salesforce and CTMS is preferred.
• Strong attention to detail and problem solving abilities are essential.
• Excellent written and verbal communication and interpersonal skills.

Responsibilities

• Communicate regularly with sites and field team to resolve basic queries.
• Investigate and analyze discrepancies between site and JDE data on device accountability with stakeholders.
• Provide training on device accountability processes within electronic databases (e.g., Salesforce) for cross-functional teams.
• Identify and implement basic process improvements to trial workflow timelines.
• Support regulatory reporting with accurate data for bodies like the FDA.

Skills

Attention to detail

Problem solving

Communication skills

Teamwork

Organizational skills

Analytical thinking

Education

Bachelor's degree in related field

Tools

JD Edwards

Salesforce

CTMS

MS Office

Job description

Edwards in Irvine, CA is seeking a Clinical Trial Coordinator with a Bachelor's degree and 1 year of trial management experience. You will partner with sites, clinical teams, and regulatory bodies to ensure device accountability data is accurate and timely.

Key responsibilities include training teams on trial processes, resolving data discrepancies, and contributing to regulatory submissions while maintaining strict compliance and high-quality data integrity.