DaVita Kidney Care

Regulatory Affairs Coordinator

DaVita Kidney Care

full-time

Posted on:

Location Type: Remote

Location: Remote • Minnesota • 🇺🇸 United States

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Salary

💰 $70,512 - $117,769 per year

Job Level

Mid-LevelSenior

About the role

  • 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
  • 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
  • Maintain site regulatory files for the duration of the study.
  • 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)
  • 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
  • Other duties as assigned.

Requirements

  • Education High School Diploma or equivalent is required. Bachelor’s Degree is strongly preferred.
  • 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.
  • 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. Effectives 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.
Benefits
  • 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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Clinical ResearchRegulatory AffairsQuality ControlElectronic Trial Master File (eTMF)Document ManagementRegulatory SubmissionsAudit PreparationData AnalysisDocumentation ReviewProject Coordination
Soft skills
CommunicationAnalytical SkillsOrganizational SkillsAttention to DetailProblem SolvingInterpersonal SkillsPlanningTeam CollaborationTime ManagementAdaptability