Clinical QA Coordinator

Clinical QA Coordinator – Irving, TX

Kelly Science & Clinical is seeking a full‑time Clinical QA Coordinator. This position is contract to hire and fully benefited. As a Kelly employee you will be eligible for medical, dental, 401K, paid time off (holiday, vacation, sick/personal), and a variety of other benefits.

• Shift:
  Monday - Friday 6:30am - 3:30pm or 9:30am-6:30pm
• Compensation: $24-28.80/hr DOE

• 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 ensures they are within the range
• Verifies if there are any test articles on the floor inside 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 files 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 enters 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 logs 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 gives an update on their study status
• Performs other duties as may be assigned from time to time

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

• Current certification in Human Protections
• Current certification in Good Clinical Practices (GCP)
• Current certification in Bloodborne Pathogens

• Technical & Computer
  
  Skills:
  
  Proficiency with Microsoft Office (Word, Excel, Outlook) and Database software (File Maker Pro)
• Attention to Detail:
  Proven thoroughness in monitoring quality standards and reviewing complex data tables
• Organization & Planning:
  Excellent prioritization skills with flexibility to manage changing clinical priorities
• Communication:
  Strong verbal and written communication skills; ability to collaborate ethically and professionally across teams

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work‑related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short‑term disability. As a Kelly…