Hybrid Clinical Regulatory & Data Coordinator I

ERA Health Research; Redmond (WA); Hybrid; USD 71,635,000 - 83,097,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k Retirement Savings Plan

PTO and leave

Floating holidays

Job summary

ERA Health Research seeks a Full-Time Regulatory and Data Coordinator I to support clinical trial operations in Redmond, WA. Hybrid work model with on-site training as needed. Responsibilities include regulatory document management, data integrity, and monitoring visit support.

Required 1–2 years in clinical research, strong regulatory knowledge, and proficiency in EDC and Microsoft Office. Relocation assistance is not available.

Qualifications

• Bachelor’s degree or equivalent experience in science, healthcare, compliance/regulatory field.
• 1–2 years in clinical research and regulatory support in healthcare or trials.
• Knowledge of clinical research processes, regulatory compliance and IRB submissions.
• Familiarity with GCP guidelines, SOPs and regulatory binder management.
• Proficiency in EDC systems and data verification techniques.
• Strong attention to detail and accuracy in data management.
• Good communication with monitors, clinical teams and sponsors.

Responsibilities

• Regulatory expertise for study conduct as SME.
• Manage SIP preparation, submission and tracking.
• Prepare for monitoring visits and ICF reviews; assist during visits.
• Maintain regulatory binder and perform quality control reviews.
• Prepare and submit regulatory documents to IRBs per requirements.
• Collaborate with teams to transcribe source data into EDC and ensure accuracy.
• Document management: scan and organize documents for accessibility.
• Perform additional duties as assigned by supervisor.

Skills

Attention to detail

Organizational skills

Communication skills

Education

Bachelor’s degree in Science, Healthcare, Compliance/Regulatory or related field

Tools

Microsoft Office

Job description

ERA Health Research seeks a Full-Time Regulatory and Data Coordinator I to support clinical trial operations in Redmond, WA. Hybrid work model with on-site training as needed. Responsibilities include regulatory document management, data integrity, and monitoring visit support.

Required 1–2 years in clinical research, strong regulatory knowledge, and proficiency in EDC and Microsoft Office. Relocation assistance is not available.