Want to make a positive impact in medical research?

We're hiring!

Quality and Compliance Specialist

Phoenix, Arizona

The Quality and Compliance Specialist works under the supervision of designated clinical Investigators and reviews data from clinical trial initiation throughout the trial’s duration. The Quality and Compliance Specialist assists in assuring compliance with Cognitive Clinical Trial’s standards and all applicable regulations. The QA department is responsible for review of study data, medical records, case report forms,monitoring letters, drug accountability and regulatory files.

Responsibilities and Essential Duties:

· Plans, schedules,and conducts internal quality assurance audits of the processes, procedures, and controls employed in the design, conduct, and analysis of clinical trials

· Documents audit observations and prepares audit reports

· Communicates observations to clinical investigators, senior study coordinators, training supervisor, and management

· Reviews essential documents such as original source data, medical records, and informed consent forms

· Conducts internal audits in preparation for sponsor, regulatory agency or FDA inspection and ensures compliance with Standard Operating Procedures and applicable regulatory requirements

Experience:

5 years of clinical research experience

Previous quality assurance with clinical trials preferred

Must be detail oriented, well organized, and can work independently

Knowledge of audit techniques

Apply to work with us!

Apply for: Quality and Compliance Specialist
Located in: Phoenix, Arizona
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