Administrative Assistant - Regulatory

About the role

ERA Health Research is seeking a Full-time Regulatory Administrative Assistant to join our team in Redmond, WA. This role plays a critical role in providing administrative and operational support to the Regulatory department to ensure the efficient regulatory management of clinical research studies. The ideal candidate is highly organized, detail-oriented, and committed to maintaining accurate documentation while supporting compliance with company procedures and applicable regulatory requirements in a fast-paced clinical research environment. This is a fully onsite role and requires working from our Redmond, WA office; it is open only to applicants who are current Washington State residents.

Responsibilities

• Support the Regulatory team with day-to-day departmental operations and administrative functions.
• Assist with departmental process improvements and help maintain efficient workflows.
• Prepare, organize, scan, upload, maintain, and archive regulatory documents and files.
• Assist with the creation, organization, and maintenance of regulatory binders and other related items.
• Monitor regulatory files to ensure required documentation is current and complete.
• Coordinate document collection from internal departments and study sites as requested.
• Assist with preparation for and follow-up to audits, sponsor visits, and regulatory inspections.
• Accurately transcribe source data into EDC systems in accordance with study protocols and established standards.
• Ensure the accuracy and completeness of data by cross-referencing it with source documents.
• Execute EDC activities in alignment with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) guidelines, and other applicable regulatory requirements.

Requirements

• High School Diploma (required).
• Minimum of 1 year of administrative, document management, or office support experience (required).
• Strong organizational skills with exceptional attention to detail.
• Ability to manage multiple tasks and meet deadlines.
• Strong written and verbal communication skills.
• Ability to work independently and collaboratively within a team.
• Proficiency in Microsoft Office (Word, Excel, Outlook).

Qualifications

• Associate degree in Business Administration, Office Administration, Regulatory Affairs, or a related field (preferred).
• Experience supporting clinical research or regulatory operations (preferred).
• Familiarity with FDA regulations, ICH Good Clinical Practice (GCP), and clinical trial documentation (preferred).
• Experience with quality control (QC) and database systems (preferred).

Pay

Pay Range: $24.00 - $26.00 per hour. Pay is based upon candidate experience and qualifications, as well as market and business considerations.

Benefits

• Medical, dental, and vision insurance.
• Flexible Spending Account (FSA) and Health Savings Account (HSA) options.
• 401k Retirement Savings Plan.
• Paid time off (PTO) starting at 10 days per year.
• 1 hour of sick leave for every 40 hours worked.
• 2 Floating Holidays per year.