Quality Assurance Manager
Renstar Medical Research, an established clinical research site in Ocala, Fl, is seeking a full-time Quality Assurance Manager.
Responsibilities include: investigating and drafting corrective action and prevention plans for upper-management review; drafting standard operating procedures and work instructions for activities related to conducting clinical research trials at a research site; identifying areas or risk regarding processes or procedures; identifying trends in job quality and making recommendations for improvement; designing, implementing , and maintaining training documents and programs that will demonstrate continuous quality improvement and staff education; working with staff in a respectful and collaborative manner to research issues, identify solutions, and implement changes; oversee and maintain internal auditing program for medical records and worksheets; review summary reports for trends and risks.
This position will also include project management tasks including but not limited to tasks such as implementing company wide systems changes, such as the implementation of an electronic records systems, new forms and documentation requirements, new policies and procedures, and successfully building support and fostering high morale from site staff.
Qualified candidates will have strong understanding of operational processes and procedures at a clinical research site; strong computer skills; strong written and verbal communications skills; experience creating flowcharts and diagrams, mastery of Microsoft Excel, experience creating SOPs and Work Instructions, experience creating CAPAs, the ability to execute strategic goals related to quality identified by upper management. A candidate with clinical research industry experience and prior certification in GCP/ICH training is strongly preferred.
Established multi-disciplinary pharmaceutical/clinical research site.