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Sr. Quality Assurance Associate

Integrated Resources, Inc Westwood Full-Time
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Job Title
Senior Associate Clinical Quality Assurance

Assure a high level of quality in *** global clinical research projects, as defined in Federal Regulations, local regulations, GCP, *** policies and applicable industry standards.

Support the outsourcing of Clinical Investigator Site Audits
Conduct Trial Master File Audits, Clinical Study Report audits and Internal Process Audits
Assist with health authority inspection preparation and facilitation
Conduct peer reviews of audit reports
Act as a scribe during meetings and author meeting minutes

The position will require independent decision making for (but not limited to) the following:
Conducting peer reviews of audit reports
Providing GCP guidance to external customers
Risk assessments of audit observations and audit observation responses

Bachelor s degree in associated functional discipline, advanced degree preferred
Clinical Quality Assurance experience
Fundamental knowledge of US, EU and International regulatory standards and guidelines for the conduct of clinical trials.
Technical and administrative capabilities to carry out routine audits with minimal supervision or to play a supporting role in more complex audits
Must be analytical and thorough in work habits and report writing
Must have mature and professional communications skills, strong independent time management skills and the ability to multi-task
No travel required
 

Recommended skills

Clinical Research
Clinical Trials
Trial Master File
Good Clinical Practices (Gcp)
Time Management
Auditing
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Job ID: 19-13945

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