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  • 2626 North Webb Road
    Wichita, KS 67226

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Clinical Research Regulatory Specialist

Wichita Urology Group • Wichita, KS

Posted 20 days ago

Job Snapshot

Full-Time
Experience - At least 3 year(s)
Healthcare - Health Services
Health Care
54

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Job Description

Clinical Research Regulatory Specialist

Job Title:                                 Clinical Research Regulatory Specialist

Department:                          Clinical Research 

Overtime Status:                   Non-Exempt

Position reports to:             Clinical Research Coordinator

Location of position:           Wichita, KS

Position Summary:             

  • Determine and interpret applicable rules and regulations associated with Wichita Urology’s clinical research studies and trials, ensuring the protection, safety and welfare of our patients
  • Ensure compliance to the rules and regulations from the staff
  •  Develop and compile research protocol documents and all materials required for regulatory submissions in compliance with policies from the state and Wichita Urology
  • Guide and coordinate all associated submission, documentation and reporting processes
  • Will perform internal audits and inspections and report the findings
  • Will perform assigned activities of investigative sites in all phases of clinical trials
  • Maintain regulatory documents, monitor and recommend improvements for upkeep of regulatory documents
  • Will work closely with the Clinical Research Coordinator and Clinic Research Assistant
  • May serve as primary liaison on safety issues and reporting procedures 

Job Requirements

Required Qualifications:

  • Bachelor’s degree preferred
  • 3-5 years of experience in the clinical research field
  • Prior regulatory experience

Physical Requirements:     

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Average, ordinary, visual acuity necessary to prepare or inspect documents or products, or operate machinery.
  • Prolonged periods of sitting, standing or walking may be required, should be able to transport approximately 0-25lbs of charts or files.
  • Occasional assistance in patient transfers of up to 50lbs.

Working Conditions:

  • While performing the duties of this job, the employee is frequently exposed to blood, body fluids, fumes, or airborne particles, and sharp objects potentially contaminated with blood borne pathogens or other infectious agents.
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