Regulatory Affairs Administrative Assistant

Posting Date

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/paternity leave and more Professional development programs: DaVita offers a variety of programs to help strong performers grow within their career and also offers on-demand virtual leadership and development courses through DaVita's online training platform StarLearning.

Here is what you can expect when you join our Village:
* A "community first, company second" culture based on Core Values that really matter.
* Clinical outcomes consistently ranked above the national average.
* Award-winning education and training across multiple career paths to help you reach your potential.
* Performance-based rewards based on stellar individual and team contributions.
* A comprehensive benefits package designed to enhance your health, your financial well-being and your future.
* Dedication, above all, to caring for patients suffering from chronic kidney failure across the nation.

Salary/ Wage Range

Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience and may fall outside of the range shown. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at https://careers.davita.com/benefits

Join us as we pursue our vision "To Build the Greatest Healthcare Community the World has Ever Seen."
Why wait? Explore a career with DaVita today.
Go to http://careers.davita.comto learn more or apply

#LI-JD2

At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and comply with state and federal affirmative action requirements. Individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic.

This position will be open for a minimum of three days.

Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at https://careers.davita.com/benefits

Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.