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Full-Time

Clinical Research Assistant

Confirmed live in the last 24 hours

Fresenius Medical Care

Fresenius Medical Care

11-50 employees

Provides dialysis and renal healthcare services

Healthcare

Compensation Overview

$18 - $28Hourly

Entry

Denver, CO, USA + 1 more

More locations: Cherry Hills Village, CO, USA

Category
Public Health
Biology Lab & Research
Biology & Biotech
Required Skills
Google Cloud Platform
Requirements
  • High School Diploma required.
  • Certified Medical Assistant preferred.
  • 0-1 year experience in a medical setting and/or clinical research preferred.
  • Willingness to obtain research specific training as needed.
  • Must be able to meet deadlines for multiple concurrent projects.
  • Ability to understand and follow study specific protocol and direction.
  • Ability to understand a dialysis medical record.
  • Attention to detail a must.
  • Proficient with PCs and Microsoft Office applications.
  • Strong communication skills, verbal and written.
  • Strong organizational skills.
  • Ability to take direction.
Responsibilities
  • Assists with obtaining and preparing regulatory/essential documents throughout the duration of a study including, but not limited to, FDA 1572, CVs, professional licensure, financial disclosure forms and IRB submission forms.
  • Under close supervision, ensures documents and forms are compiled and submitted in a timely manner to the CRO, study sponsor or IRB as applicable.
  • Assists with maintaining constant communication with Institutional Review Boards, study sponsors, dialysis facility, practice and field staff as necessary to ensure timely study start-up or the effective and efficient progression of the study.
  • Assists with the contracting process, document preparation and execution as required during study start-up activities and throughout the duration of a study.
  • Under close supervision, interfaces with potential study subjects for the purpose of promoting participation in research studies.
  • Assists with the screening of subjects for participation eligibility using inclusion/exclusion criteria as outlined in the study protocol and under the direction of the PI.
  • Assists with and documents the obtaining of informed consent according to GCP.
  • Assists with 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 in accordance with timelines established by the study sponsor.
  • 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 by the PI, Director, or other site personnel.
  • 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, as deemed necessary.
  • Review and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
  • Assists with various projects as assigned by direct supervisor.
Fresenius Medical Care

Fresenius Medical Care

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Fresenius Medical Care North America focuses on delivering high-quality healthcare services to individuals with kidney and other chronic conditions. The company operates a vast network of dialysis centers and outpatient labs for cardiac and vascular care, ensuring coordinated treatment for many patients across the continent. It stands out as the largest fully integrated renal company, providing not only dialysis services but also specialty pharmacy and laboratory services. Additionally, Fresenius manufactures and distributes a wide range of dialysis equipment, disposable products, and renal pharmaceuticals. The goal of Fresenius Medical Care is to enhance the quality of life for patients with chronic illnesses by providing comprehensive and accessible healthcare solutions.

Company Stage

N/A

Total Funding

$39.1M

Headquarters

Waltham, Massachusetts

Founded

N/A

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

0%
Simplify Jobs

Simplify's Take

What believers are saying

  • FMCNA's leadership in the renal care market provides employees with a stable and reputable work environment.
  • The company's innovative initiatives, such as the virtual reality kidney education program, demonstrate a commitment to leveraging technology for patient care.
  • Recognition from Newsweek and other organizations highlights FMCNA's positive workplace culture and investment in employee development.

What critics are saying

  • The highly regulated healthcare industry could pose compliance challenges and impact operational flexibility.
  • Dependence on government grants and funding, as seen with the Mississippi Department of Health grant, may introduce financial uncertainties.

What makes Fresenius Medical Care unique

  • Fresenius Medical Care North America (FMCNA) is the world's largest fully integrated renal company, offering a comprehensive line of dialysis equipment, disposable products, and renal pharmaceuticals.
  • Their extensive network of dialysis facilities and outpatient cardiac and vascular labs provides coordinated healthcare services at pivotal care points, setting them apart from competitors.
  • FMCNA's commitment to employee well-being and professional development has earned them a spot on Newsweek's 100 Most Loved Workplaces for two consecutive years.

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