The Investigational Drug Services (IDS) and Pharmacy Regulatory Coordinator collaborates closely with the Clinical Pharmacy Specialists for Investigational Drug Services to ensure appropriate handling, preparation, packaging, labeling and billing of investigational medicinal products. The position is also responsible for performing unit inspections/drug storage reviews/audits of locations performing investigational medication administration as well as ambulatory sites to ensure compliance with medication management standards. Assists in the auditing of medications, supplies, samples and patient's own medication storage. As an integral member of Pharmacy Services, the IDS/Pharmacy Regulatory Coordinator's role also includes assuring accurate record keeping, filling, compounding and delivering of investigational drug products to study coordinators, study nurses and patients. Assists in preparing investigational study budgets, reconciling billing, charging costs centers and research grants. Investigational medications include, but are not limited to, intravenous admixtures, chemotherapy, NIOSH group 1, 2 and 3 medications, total parenteral nutrition, oral bulk/unit dosed or prepackaged medications, compounds, cellular and gene therapy, chemicals/gases and other investigational drugs/devices.