Regulatory & Data Coordinator I – Clinical Trials

Era Health Research, LLC; Redmond (WA); Hybrid; USD 52,000 - 73,000; Full time

Benefits offered by this job

Medical, dental, and vision

FSA/HSA options

401k Retirement Savings Plan

PTO + 1 hour sick leave per 40 hours

Floating holidays

Job summary

ERA Health Research, LLC in Redmond, WA, seeks a Full-Time Regulatory and Data Coordinator I to support clinical trial operations, regulatory documents, data quality, and monitoring visit prep.

The role offers a hybrid work model with on-site training during the initial period; relocation is not provided. The successful candidate will liaise with CRAs, sponsors, and research teams to ensure regulatory compliance and smooth study activation.

Qualifications

• Bachelor’s degree or equivalent work experience in related field.
• 1-2 years of clinical research/regulatory support experience.
• Knowledge of regulatory processes and IRB submissions.
• Familiarity with GCP, SOPs and binder management.
• Proficiency with EDC systems and data verification.
• Strong attention to detail and organizational skills.
• Effective communication with monitors, teams and sponsors.

Responsibilities

• Regulatory Binder Management and compliance review.
• Study activation: SIP prep, IRB submissions and setup.
• Support monitoring visits and address action items.
• Transcribe source data into EDC and ensure data integrity.
• Prepare and scan regulatory documents for systems.
• Collaborate with clinical operations and sponsors on site.

Skills

Regulatory knowledge

GCP familiarity

Attention to detail

Communication skills

Organizational skills

Problem-solving

Education

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

Tools

EDC systems

Microsoft Office

Job description

ERA Health Research, LLC in Redmond, WA, seeks a Full-Time Regulatory and Data Coordinator I to support clinical trial operations, regulatory documents, data quality, and monitoring visit prep.

The role offers a hybrid work model with on-site training during the initial period; relocation is not provided. The successful candidate will liaise with CRAs, sponsors, and research teams to ensure regulatory compliance and smooth study activation.