Clinical Trials Regulatory & Data Coordinator (Hybrid)

Eastside Research Associates; Redmond (WA); Hybrid; USD 34,000 - 40,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k Retirement Savings Plan

Paid time off (PTO)

Floating holidays

Job summary

ERA Health Research in Redmond, WA seeks a Full-Time Regulatory and Data Coordinator I to support study activation, regulatory document management, and data quality. Hybrid work model with on-site training initially. Responsibilities include IRB submissions, EDC data entry, regulator binder maintenance, and monitoring preparation.

The role requires a Bachelor’s degree in a related field and 1–2 years of regulatory support experience, plus strong attention to detail and communication skills.

Qualifications

• Bachelor’s degree in Science, Healthcare, Compliance/Regulatory or related field or equivalent work experience.
• 1-2 years of clinical research and regulatory support in a healthcare or clinical research setting.
• Knowledge of clinical research processes including regulatory compliance and IRB submissions.
• Familiarity with GCP guidelines, SOPs, and regulatory binder management.
• Proficiency in EDC systems and understanding of data verification techniques.
• Knowledge of clinical trial terminology and regulatory standards.
• Proficiency in Microsoft Office (Excel, Word, Outlook).
• Strong attention to detail and accuracy in data management.
• Strong organizational and time management skills to manage multiple tasks and deadlines.
• Effective communication with monitors, clinical teams, and sponsors.

Responsibilities

• Regulatory expertise as the subject matter expert for study conduct.
• Manage preparation, submission, and tracking of SIPs for clinical studies and IRB approvals.
• Prepare for Interim Monitoring Visits and assist monitors on site.
• Maintain Regulatory Binder and perform quality control reviews of patient files.
• Prepare and submit regulatory documents to IRBs.
• Transcribe source data into EDC systems and ensure data integrity.
• Prepare and scan documents into EDC systems and databases.
• Perform other duties as assigned by supervisor or manager.

Skills

Clinical research

Regulatory compliance

GCP knowledge

Data quality

Communication

IRB submissions

EDC systems

Microsoft Office

Education

Bachelor's degree in Science/Healthcare/Regulatory

Tools

EDC systems

Microsoft Office

Job description

ERA Health Research in Redmond, WA seeks a Full-Time Regulatory and Data Coordinator I to support study activation, regulatory document management, and data quality. Hybrid work model with on-site training initially. Responsibilities include IRB submissions, EDC data entry, regulator binder maintenance, and monitoring preparation.

The role requires a Bachelor’s degree in a related field and 1–2 years of regulatory support experience, plus strong attention to detail and communication skills.