Regulatory Affairs Coordinator II

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.

Sound like you? Then you might be a great fit for our Regulatory Affairs Coordinator II position with DaVita Clinical Research (DCR)

We are looking for a highly committed individual who is seeking to performs tasks associated with the process of regulatory site start-up and regulatory document maintenance in accordance with applicable regulations, standard operation procedures (SOPs), and project requirements based on established protocols and criteria for each study.

This position is a remote position and will be based out of a home office. This individual can be located anywhere within the U.S, and does not need to be located within Minneapolis.

ESSENTIAL DUTIES & RESPONSIBILITIES:
40% - Coordinate site regulatory start-up and maintenance activities throughout the course of assigned studies under the guidance of Quality and Regulatory Sr. Manager or with support of a Sr. Regulatory Coordinator. This includes:

• Draft and distribute site regulatory documents to investigative sites

• Collect and perform quality check of site regulatory documents and submit regulatory packages to study sponsors and/or CROs (Clinical Research Organizations) following established study requirements

• Submit study sites to the IRB (Institutional Review Board) and ensure that approvals are obtained; may also require submission and management of study protocols

• Conduct routine follow-up with sites to ensure documentation is complete and resolve outstanding issues

15% - Track and report regulatory document status and start-up activities to project team members and sponsors/CROs to ensure project timelines and study deliverables are met

20% - Maintain site regulatory files for the duration of the study.

15% - Ensure accurate and timely completion of maintenance of internal systems and tracking tools with site and study information.

• This includes inputting key dates, documents and applicable information into the CTMS (Clinical Trial Management System)

5% - Provide additional administrative support to the Regulatory Affairs Team, which includes:

• Attend team meetings, phone conferences, and training as required

• Understand and follow teammate guidelines, employment policies, and department/company procedures

5% - Other duties as assigned.

REQUIREMENTS:

• Education

  • High School Diploma or equivalent is required.

  • Bachelor's Degree is strongly preferred.

• Experience

  • Minimum of 3 years of experience in Clinical Research, preferably as a clinical research coordinator, and/or either a quality or regulatory affairs role is required

  • Minimum of 3 years of experience within Regulatory Affairs and/or Quality is required. Preferably in a clinical research setting.

  • Extensive experience with Electronic Trial Master File (eTMF) systems, including maintaining essential study documents, ensuring completeness and inspection readiness, supporting audit preparation, overseeing document quality control, and collaborating with study teams to ensure timely, accurate, and compliant filing in accordance with regulatory and sponsor requirements is required

  • Minimum of 2 or more years of Administrative experience, including managing schedules, organizing complex documentation, coordinating meetings, and supporting cross-functional teams in a fast-paced environment is required.

• Skills & Competencies

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

  • Strong experience writing, reviewing, editing, and submitting a wide variety of documentation.

  • Effective verbal communication skills with the ability to interact professionally at multiple organizational levels.

  • Exceptional organizational and planning abilities.

  • Strong attention to detail and accuracy, with demonstrated ability to identify, investigate, and resolve discrepancies.

  • Advanced proficiency in the Microsoft Office Suite and document-publishing tools used for regulatory submissions.

• Additional Requirements

  • Ability to travel up to 10% based on business needs.

  • Nights and weekends are generally not required; however, certain timelines or project demands may require occasional off-hours 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.com to 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.