Clinical QA Coordinator

Kelly Science & Clinical is seeking a Clinical QA Coordinator near Irving, TX. This role is a full-time, fully benefited position. As a Kelly employee you will be eligible for Medical, Dental, 401K, and a variety of other benefits to choose from. You’ll also be eligible for paid time off, including holiday, vacation, and sick/personal time. 

Contract to Hire
Shift: Monday – Friday 6:30am – 3:30pm or 9:30am-6:30pm 
Compensation: $24-28.80/hr DOE 

Key Responsibilities

• Checks the patch booths before they are opened to ensure that the patch type and testing conditions are correct and patches have test article on them
  

  • Verifies humidity and temperature of retain closet, test article closet, drug closet, server room and archive room and ensure that they are within the range
    

  • Verifies if there are any test articles on the floor inside the retain closet, test article closet and drug closets
    

  •  Verifies temperature for incubators, refrigerators and freezers and ensures that the temperature is within specified range
    

  • Verifies that balances are level
    

  • Verifies balances for calibration
    

  • Maintains and file all logs in their respective binders
    

  
  

• When applicable, witnesses jar fill prior to study start
  

• Reviews Informed Consent Forms signed by subjects and Medical History Forms
  

• Conducts In-study audits
  

• Inventories the test articles that are received and enter them into the respective inventory log
  

• Maintains Standard Operating Procedures
  

• Ensures that the studies are compliant with protocols and Standard Operating Procedures and are conducted in compliance with Good Clinical Practices
  

• Assists Quality Assurance Coordinator II or Manager, Quality Assurance in writing new Standard Operating Procedures when necessary
  

• Maintains keys to restricted areas (retain closet, drug closets, test article closet and archives)
  

• Attends protocol meetings for assigned studies
  

• Maintains Signature/Initials log, Curriculum Vitae binder for physicians.
  

• Assists Quality Assurance Coordinator II with maintaining training records, Curriculum Vitae for employees, Standard
  

• Operating Procedure and Standard Training Procedure acknowledgements from employees.
  

• Ensures equipment (timer, pipettes and thermometers) and standard weights are checked for calibration on a regular basis, monthly expiration check.
  

• Ensures that Fume Hood is checked for certification every six months
  

• Reviews Study Administrative Notebooks/regulatory binder prior to the beginning of the study.
  

• Reviews Data sheets for completeness and accuracy
  

• Reviews data tables to ensure accuracy of data
  

• Reviews data tables after statistical analyses are performed to ensure accuracy of the data
  

• Reviews Serious and non-serious Adverse events to ensure subject’s safety and accuracy of reported data
  

• Maintains retain samples of test articles and log them into the retain log
  

• Maintains accountability for test articles during the course of the study until the study ends
  

• Attends study status meetings and give an update on their study status
  

• Performs other duties as may be assigned from time to time

Qualifications & Requirements
Education & Experience

• Bachelor’s Degree (BA/BS) from a four-year college or technical school; and 1 year of related experience and/or training

Certifications & Licenses (Preferred)

• Current certification in Human Protections
  

• Current certification in Good Clinical Practices (GCP)
  

• Current certification in Bloodborne Pathogens

Core Competencies & Skills

• Technical & Computer Skills: Proficiency with Microsoft Office (Word, Excel, Outlook) and Database software (FileMaker Pro).
  

• Attention to Detail: Proven thoroughness in monitoring quality standards and reviewing complex data tables.
  

• Organization & Planning: Excellent prioritization skills with the flexibility to manage changing clinical priorities.
  

• Communication: Strong verbal and written communication skills; ability to collaborate ethically and professionally across teams.

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