Regulatory Affairs Administrative Assistant - Remote

Overview

The Regulatory Affairs Administrative Assistant will support the operational excellence initiatives for the DaVita Clinical Research team by managing regulatory documents necessary for research studies and ensuring compliance with federal and GCP guidelines.

In Short

• Manage regulatory activities for clinical trials.
• Oversee Regulatory Affairs Coordinators for projects.
• Act as a main contact for site start-up issues.
• Support review of regulatory document filings.
• Attend team meetings and manage agendas.
• Assist in reviewing IRB submissions.
• Maintain IRB study access for teammates.
• Perform other assigned duties.
• Work in a collaborative environment.
• Commit to DaVita’s values in all interactions.

Requirements

• High School Diploma required; Bachelor's preferred.
• 1+ years of Clinical Research experience preferred.
• 2+ years of administrative experience in a fast-paced setting.
• Excellent research and analytical skills.
• Strong verbal and written communication skills.
• Advanced computer skills (MS Office, Adobe Acrobat).
• Ability to manage confidential information.
• Strong organizational and planning skills.
• Commitment to DaVita’s values.
• Up to 10% travel may be required.

Benefits

• Flexible work schedule based on business needs.
• Comprehensive benefits including medical, dental, and vision.
• 401(k) match and paid time off.
• Support for family resources and EAP counseling.
• Professional development programs available.
• Performance-based rewards.
• Dedication to patient care and community values.
• Access to online training and leadership courses.
• Wellness breaks during the holiday season.
• Commitment to a diverse and inclusive workplace.