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Clinical Research Coordinator I

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Fresenius Kidney Care Eupora

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Location:
United States of America , Mishawaka

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

Supports Frenova Renal Research by providing administrative and clinical support for the implementation and conduct of clinical trials under the direct supervision of the Principal Investigator (PI), Director, and other site personnel as applicable. Responsible for the collection and submission of regulatory documents, performance of study specific procedures, regulatory reporting requirements as instructed by the PI and governed by Good Clinical Practice (GCP) and ICH guidelines, and assisting with ongoing study activity.

Job Responsibility:

  • Utilizes experience and knowledge to act as a resource and provide on-going leadership and support to Clinical Research Assistant I
  • Conducts on the job training for Clinical Research Assistant I as requested
  • Researches and identifies research related issues and discrepancies
  • Obtains and prepares regulatory/essential documents throughout the duration of a study
  • Ensures documents and forms are compiled and submitted in a timely manner
  • Assists with maintaining constant communication with Institutional Review Boards, study sponsors, dialysis facility, practice and field staff
  • Assists with the contracting process, document preparation and execution
  • Interfaces with potential study subjects for the purpose of promoting participation in research studies
  • Assists with screening subjects for participation eligibility
  • Assists with and documents the obtaining of informed consent according to GCP
  • Responsible for the timely and accurate data entry of study specific data into case report forms
  • Assists with addressing and resolving study sponsor questions, concerns, and queries
  • Processes and ships study specific lab specimens as directed by the PI
  • Performs study specific procedures at protocol directed intervals under the supervision of the PI
  • Provides general support for research projects as directed
  • Obtains and updates essential documents for specific studies, as necessary
  • Attends clinical research-related training as required
  • Assists with study close-out activities as directed by PI
  • Completes the clinical trials management system and electronic/paper case report forms in an accurate and timely manner
  • Escalates issues to supervisor for resolution
  • Assist with various projects as assigned by direct supervisor
  • Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations

Requirements:

  • High School Diploma required
  • Associate’s Degree or Certified Medical Assistant preferred
  • 2-4 years of experience of related experience preferred
  • Minimum 18 months experience in a medical setting and/or clinical research setting required
  • Willingness to obtain research specific training as needed
  • Ability to meet deadlines for multiple concurrent projects
  • Ability to understand and follow study specific protocol and direction
  • Ability to understand a patient medical record
  • Attention to detail required
  • Good computer skills including MS Excel
  • Strong communication skills, verbal and written
  • Strong organizational skills
  • Ability to take direction

Nice to have:

  • Associate’s Degree or Certified Medical Assistant
  • 2-4 years of experience of related experience
What we offer:
  • Healthcare
  • Continuing Education
  • Paid Time Off
  • Collaborative Environment
  • Additional Perks
  • 401(k) Retirement Saving

Additional Information:

Job Posted:
April 11, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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