Hybrid Clinical Trials Regulatory & Data Coordinator I

ERA Health Research; Redmond; Hybrid; AUD 49,000 - 69,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

FSA/HSA options

401k Retirement Savings Plan

PTO 10 days/year (+ sick leave)

Job summary

ERA Health Research invites applications for a Full-Time Regulatory and Data Coordinator I in Redmond, WA. This role blends regulatory expertise with data coordination to support trial activation, regulatory binder upkeep, and EDC data integrity.

You will work in a hybrid setting, collaborating with CRAs, sponsors, and clinical teams, while ensuring compliant study conduct and timely monitoring preparation.

Qualifications

• Bachelor's degree or equivalent work experience in science, healthcare, or regulatory field.
• 1–2 years of clinical research and regulatory support experience.
• Familiarity with GCP guidelines, SOPs, and regulatory binder management.
• Proficiency with EDC systems and data verification techniques.
• Strong attention to detail and ability to manage multiple deadlines.

Responsibilities

• Support study activation, regulatory document management, and submission tracking.
• Assist with IRB submissions and regulatory binder maintenance.
• Transcribe data into EDC systems per protocol and ensure accuracy.
• Prepare for monitoring visits and address queries and action items.
• Collaborate with CRAs, sponsors, and research teams to maintain compliance.

Skills

Regulatory compliance

Clinical research knowledge

EDC systems

Document management

Communication skills

Attention to detail

Time management

Problem solving

Microsoft Office

Education

Bachelor’s degree in Science or related field

Tools

EDC software

Job description

ERA Health Research invites applications for a Full-Time Regulatory and Data Coordinator I in Redmond, WA. This role blends regulatory expertise with data coordination to support trial activation, regulatory binder upkeep, and EDC data integrity.

You will work in a hybrid setting, collaborating with CRAs, sponsors, and clinical teams, while ensuring compliant study conduct and timely monitoring preparation.