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 (File Maker 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.