Hybrid Regulatory & Data Coordinator - Clinical Trials

ERA Health Research; Redmond (WA); Híbrido; USD 34.000 - 40.000; Tempo integral

Benefícios oferecidos por esta vaga

Medical, dental, and vision insurance

Flexible Spending Account (FSA) and Hs

401k Retirement Savings Plan

PTO starting at 10 days per year and 1

Sick leave 1 hour per 40 hours worked

Two Floating Holidays per year

Resumo da vaga

ERA Health Research is seeking a Full-Time Regulatory and Data Coordinator I to support clinical trial operations from Redmond, WA. The hybrid role includes regulatory document management, ED C data entry, IRB submissions, and monitoring visit preparation as part of a cross‑functional team.

The ideal candidate has a bachelor’s degree in a related field and 1–2 years in regulatory support, with strong attention to detail, organization, and communication skills to liaise with monitors, clinical

Qualificações

• 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 skills for liaising with monitors, clinical teams, and sponsors
• Problem‑solving abilities to address queries and resolve action Items effectively

Responsabilidades

• Regulatory Expertise: Serve as the subject matter expert for regulatory aspects of clinical study conduct.
• Study Activation: Manage the preparation, submission, and tracking of SIPs for clinical studies; collect essential regulatory documents and prepare IRB submissions.
• Monitoring Visits: Prepare for IMVs, review ICFs, verify source data, and assist monitors during onsite visits.
• Regulatory Binder Management: Maintain the Regulatory Binder and support QC reviews of patient files.
• IRB Submissions: Prepare and submit regulatory documents to IRBs per study requirements.
• EDC: Transcribe source data into EDC systems per protocol and maintain data integrity.
• Document Management: Scan and file documents into EDC systems and databases.
• Other Duties: Perform additional tasks as assigned by supervisors.

Conhecimentos

Attention to detail

Organizational skills

Time management

Communication skills

Problem-solving

Formação

Bachelor’s degree in Science/Healthcare/Regulatory

Ferramentas

EDC systems

Microsoft Office

Descrição da vaga

ERA Health Research is seeking a Full-Time Regulatory and Data Coordinator I to support clinical trial operations from Redmond, WA. The hybrid role includes regulatory document management, ED C data entry, IRB submissions, and monitoring visit preparation as part of a cross‑functional team.

The ideal candidate has a bachelor’s degree in a related field and 1–2 years in regulatory support, with strong attention to detail, organization, and communication skills to liaise with monitors, clinical