8 days old

305521 1Clin Pharm Spec Reg

Penn Medicine
Philadelphia, PA 19104
The Investigational Quality Assurance, Clinical Pharmacist Specialist (IQACPS) ensures investigational pharmacy compliance related to regulatory and accreditation standards and regulations. The individual will be responsible for the development and execution of internal audits by examining records, reports, and operating practices, against established controls to ensure all relative operations adhere to applicable research requirements. The individual must demonstrate a highly organized ability to integrate within the healthcare team and current structure of the pharmacy department. The IQA-CPS will be responsible for the management of investigational medication safety issues and coordination of safety guidelines. The individual in this role will coordinate the development of CAPA and Root Cause Analyses that are identified when protocol deviations are reported. In addition, this individual will ensure the investigational pharmacys policies and procedures are in compliance with regulatory bodies governing research. \t\tThe candidate will also participate in design and implementation of management controls and practices to ensure that the investigational pharmacy is compliant with Federal, state and local rules and regulations, including, but not limited to PHMSA, PA State Board of Pharmacy and OSHA. The IQA-CPS will conduct process owner interviews and document end-to-end process flow charts for in-scope processes while updating existing documentation as changes occur. The candidate will collaborate with the Office of Compliance and Review and pharmacy department counterparts to ensure consistency and in preparation of internal audits. The IQA-CPS participates in unannounced mock audits or walkthroughs with process owners to ensure process and control documentation are correct. The candidate will track corrective actions to ensure all actions are completed and properly documented and will support the study teams and management during external audits by coordinating information requirements.

PharmD obtained from an accredited school of pharmacy and\t3-5 years experience. Candidates without PGY1 or PGY2 training must be Board Certified with relevant experience. Prefer PGY1 and PGY2 Medication Safety, Administration. Experience with clinical trial monitoring and auditing preferred.\nMust be PA licensed upon hire.

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Posted: 2020-03-24 Expires: 2020-04-23

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305521 1Clin Pharm Spec Reg

Penn Medicine
Philadelphia, PA 19104

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