Regulatory Affairs Administrative Assistant

Posting Date

07/29/2025

825 S 8th StSte 400, Minneapolis, Minnesota, 55404-1208, United States of America

At DaVita Clinical Research, we find that our best leaders are those who create an inspiring vision, have a desire to shape the future of medicine, and empower their team to achieve success. They enjoy tackling difficult problems and believe that the best way to solve them is through a collaborative environment that involves team efforts. They take ownership of results and instill accountability in those they lead. They are driven, compassionate, strong communicators, relationship builders, and find real fulfillment in challenging and impactful work.

We are seeking a Regulatory Affairs Administrative Assistant to assist with the operational excellence initiatives for the DaVita Clinical Research team.  This teammate will be responsible for all required regulatory documents necessary to support research studies for Clinical Trials to ensure all studies meet federal and GCP guidelines for research.

DCR prides itself on a culture of growth, transparency and feedback and would want our leaders to do that same. We want a teammate who is compassionate, purposeful and motivated by meaningful work.

ESSENTIAL DUTIES & RESPONSIBILITIES:

40% - Manage and oversee clinical trials regulatory activities throughout the course of all studies. Provide oversight of DCR clinical trials Regulatory Affairs Coordinators for assigned projects and manage resources to ensure project needs are met.
- Act as a main point of contact for information and escalation for issues related to site start-up

15% - Support the review of regulatory document filing once site start-up packets are completed.   

15% - Attend team meetings, collaborate with the regulatory leadership to create regulatory meeting agendas and manage the meeting minutes.

20% - Support the Regulatory Affairs Coordinators in reviewing IRB submissions for studies in start-up

5% - Update and maintain IRB study access for Alliance teammates 5% - Other duties as assigned.

MINIMUM QUALIFICATIONS

• High School Diploma or equivalent is required

• Bachelor's Degree is preferred

• 1 or more years of Clinical Research experience is preferred

• 2 or more years of proven administrative experience as an Executive Assistant, Administrative Assistant and/or Project Coordinator within a fast-paced setting either in a clinical research or regulated industry.  

• Excellent research, analytical and communication skills with ability to interpret legal and technical specifications.

• Excellent verbal and written communication and interpersonal skills and superior organizational and planning skills

• Excellent organizational skills Advanced computer skills (MS Word, MS Excel, MS PowerPoint, Adobe Acrobat) is preferred

• Experience in managing confidential information and/or issues using discretion and judgment.

• Commitment to and role model of DaVita’s values with ability to demonstrate those positively and proactively to patients, teammates, management, physicians, and/or vendors (Village Service Partners) in everyday performance and interactions.

• Up to 10% travel depending on business needs Nights/Weekends: Generally not required; however certain situations/timelines may require night/weekend work.

DaVita Clinical Research (DCR), a wholly owned subsidiary of DaVita Inc., is the research arm of DaVita. DCR innovates through retrospective outcomes research aimed at improving care and quality of life for people with kidney disease. DCR assists pharmaceutical and medical device companies in the design, recruitment and completion of clinical trials using its renal research site network. For 30 years we have helped 500+ clients with their development projects. DCR is based in Minneapolis, MN and operates in locations across the US.

What We’ll Provide:

More than just pay, our DaVita Rewards package connects teammates to what matters most. Teammates are eligible to begin receiving benefits on the first day of the month following or coinciding with one month of continuous employment. Below are some of our benefit offerings.

Flexible weekly work schedule: This will vary and is based on current business needs December Industry wellness break (Week between Christmas and New Year’s Day) Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out Support for you and your family: Family resources, EAP counseling sessions, access Headspace®, backup child and elder care, maternity/patern