Administrative Assistant - Regulatory

ERA Health Research is seeking a Full-time Regulatory Administrative Assistant to join our team in Redmond, WA. The Regulatory Administrative Assistant plays a critical role in providing administrative and operational support to the Regulatory department to ensure the efficient regulatory management of clinical research studies.

This role is responsible for organizing, maintaining, and processing regulatory records, preparing study and IRB documents, supporting regulatory activities, and assisting with day-to-day regulatory operations. 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.

DUTIES & 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.

QUALIFICATIONS

Required:

• High School Diploma
• Minimum of 1 year of administrative, document management, or office support experience
• 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)

Preferred:

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

PAY & BENEFITS

Pay Range: $24.00 - $26.00

Pay is based upon candidate experience and qualifications, as well as market and business considerations

ERA Health Research provides eligible employees with an opportunity to enroll in a comprehensive benefits package which includes:

• 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 and 1 hour of sick leave for every 40 hours worked.
• 2 Floating Holidays per year

EEO STATEMENT

ERA Health Research provides equal employment opportunities to all without regard to race, color, religion, sex (including sexual orientation or gender identity), national origin, age, disability, genetic information, or other protected status. Applicants and employees with disabilities may be entitled to reasonable accommodations under the terms of the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is an adjustment to our standard application and/or interview and/or employment process which will ensure an equal employment opportunity without imposing undue hardship on ERA Health Research. Please inform our team if you are requesting accommodation to complete any forms or otherwise participate in the application process or perform the essential functions of this role