Clinical QA Coordinator with Security Clearance

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: $24-30/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. 10300533