Category: Scientific & Clinical
Job ID: 132548
Date Posted: 12/06/2018
-ensuring clinical facility is prepared for a health authority inspection
-ensuring clinical sites are prepared per an inspection readiness plan.
-ensures that sponsor and site inspections are appropriately facilitated by CQA.
-manages the CQA Clinical Document Audit function (plan, prepare, perform, and report on CQA audits of Clinical Study Reports and Trial Master Files)
-audit clinical investigational sites, perform inspection readiness visits at sites, develop both audit plans and inspection readiness plans, and provide GCP/Lessons Learned training as needed.
-conduct audits of internal processes. All of these activities are essential to obtaining marketing approvals of regulatory submissions.
-Write Inspection Readiness Plans as necessary. Facilitate sponsor and site inspections as necessary.
-Develop Study Audit Plans and prepare, perform, and report on CQA audits of investigator sites
-Plan, prepare, perform, and report on CQA audits of internal processes
-Provide GCP and Lessons Learned training
-BS or MS degree in relevant field.
-4-7 years of experience in CLINICAL Quality Assurance methods and/or processes (for example, several years of clinical research study monitoring with knowledge of CQA processes)
-Ability to travel 30% of the time.
Joule, a System One division is seeking a Clinical QA Manager for our Pharmaceutical client. Candidates MUST have Clinical QA or experience with clinical qa processes such as clinical research study monitoring as well as site inspections. Candidates with QA Manufacturing experience would not be a fit for this role. With more than 6,000 employees and roughly 40 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.