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 You'll 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 You'll 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

Scheduled Weekly Hours:

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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.