Hybrid Regulatory & Data Coordinator — Clinical Trials

Era Health Research, LLC; Redmond (WA); Hybrid; USD 34,000 - 40,000; Full time

Benefits offered by this job

Hybrid work model

Medical/dental/vision insurance

401k

PTO + sick leave

Floating holidays

Job summary

ERA Health Research in Redmond, WA is seeking a Full-Time Regulatory and Data Coordinator I to support trial operations, manage regulatory documents, and ensure data quality. Hybrid work model; training on-site initially.

You will coordinate IRB submissions, EDC data entry, and binder maintenance, collaborating with CRAs and sponsors to keep studies compliant and on schedule. The role requires a Bachelor's degree and 1–2 years in clinical research; strong attention to detail and communication

Qualifications

• Bachelor’s degree or equivalent in science, healthcare, regulatory, or related field.
• 1–2 years of clinical research and regulatory support experience.
• Knowledge of regulatory processes, IRB submissions, and GCP.
• Familiarity with EDC systems and data verification.
• Strong attention to detail and organizational skills.

Responsibilities

• Serve as subject matter expert for regulatory aspects of study conduct.
• Manage SIP preparation, submission, and tracking for clinical studies.
• Prepare for interim monitoring visits and assist with source data verification.
• Maintain Regulatory Binder and perform quality control of patient files.
• Prepare regulatory documents for IRB submissions.
• Transcribe data into EDC per protocol and ensure data integrity.
• Scan and organize documents in EDC systems and databases.
• Perform additional duties as assigned.

Skills

Regulatory compliance

Clinical research

IRB submissions

EDC systems

Data quality

Documentation

Communication

MS Office

Education

Bachelor’s degree in Science/Healthcare/Regulatory

Job description

ERA Health Research in Redmond, WA is seeking a Full-Time Regulatory and Data Coordinator I to support trial operations, manage regulatory documents, and ensure data quality. Hybrid work model; training on-site initially.

You will coordinate IRB submissions, EDC data entry, and binder maintenance, collaborating with CRAs and sponsors to keep studies compliant and on schedule. The role requires a Bachelor's degree and 1–2 years in clinical research; strong attention to detail and communication