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 & SkillsTechnical & 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.
