Clinical Trials and Quality Assistant

Job Functions Duties Responsibilities and Position Qualifications:

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LOCATION: Austin TX

HOURS: 40/week

Full Time: Benefit Eligible

The primary function of the Clinical Trials and Quality Assistant is to:

Support operational activities in support of Phase I IV clinical trials in a central laboratory setting. Receives sample shipments accessions orders and properly handles samples being referred or internally tested. Ensures proper storage of biospecimen retrieves and ships to domestic and international sites. Assists project managers in obtaining site and investigator information. Day to day task management of key quality systems including: Non-Conformances and Complaints Management Document Risk Audit and Archive Management Laboratory Quality Control and Validation documents Change Control Vendor Management Training & Compliance

What Youll do:

• Assist in the management of Quality Systems as assigned by the Head of Quality including: Vendor Management program Customer Complaints Risk Management Document Control and ongoing administration of Electronic Document Management
• Management of non- Conformities Management of internal/external audits program Training Program
• Change Control Records
• Retention Data Integrity
• Perform general duties of a Clinical Trials Assistant in support of central laboratory services Serves as main point of contact for SCT USA quality reporting to global quality team Develop recommend and monitor corrective and preventive actions
• Prepare reports to communicate outcomes of quality activities Coordinate and support audits conducted by external providers
• Evaluate audit findings and implement appropriate corrective actions
• Monitor risk management activities
• Monitor and oversee change control activities Responsible for document management systems and review and approval of controlled documents.
• Assure ongoing compliance with quality and industry regulatory requirements
• Any other duties as assigned within their skills and/or qualifications

What Youll need:

• Experience in data analysis tools and statistical analysis

• High degree of integrity as it relates to following SOPs organizational policies and execution Knowledgeable of clinical testing laboratory processes customer service support biobanking shipping and receiving

• Training in Sonic Healthcare Corporate Values.

• Auditor Training.

• GCP and applicable ISO and Regulatory Requirements Training.

• Degree in Biomedical Science or Science or similar

Experience in a similar level position in a regulated environment. Experience working in a clinical laboratory pre-analytical department customer service or as a laboratory technician Experience implementing corrective action programs. Working knowledge of tools concepts and methodologies of QA. Experience with LIMS systems and specimen handling in a CAP CLIA or other accredited organization Experience working with CAP local accreditation agencies and strong working knowledge of GCP Excellent oral and written English skills. Highly developed analytical problem solving and troubleshooting skills. Time management planning and organizational skills. Demonstrated attention to detail. Ability to multi-task and work to client-prescribed deadlines. Strong Microsoft and computer applications skills. Ability to work cross functionally as part of a team independently and maintain productive and cooperative professional relationships

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Sonic Healthcare USA is an equal opportunity employer that celebrates diversity and is committed to an inclusive workplace for all employees. We prohibit discrimination and harassment of any kind based on race color sex religion age national origin disability genetics veteran status sexual orientation gender identity or expression or any other characteristic protected by federal state or local laws.