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) 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. #J-18808-Ljbffr