Location: Rochester, NY

Employer: CMSU- University of Rochester

Responsibilities:

To direct, oversee and coordinate all aspects of the Clinical Material Services Unit (CMSU) related to clinical supply operations and clinical pharmacy information services. Ensure compliance with Good Manufacturing Practices (cGMPs), Good Clinical Practices (GCPs) and Good Laboratory Practices (GLPs) standards meeting the requirements of FDA and ICH regulations and applicable professional standards pertaining to receipt, storage, inventory control, quality assurance, distribution, accountability and destruction of investigational drugs/devices. Collaborate closely with the Sr. Director and Director, Quality Assurance to ensure appropriate 21 CRF part 11 technologies are maintained at the CMSU (e.g. ClinPro LBL, temperature monitoring, etc.). Liaise directly with internal and external sponsors. Serve as a resource for clinical pharmacy information as needed in support during the planning and implementation stages of clinical studies. Manage operations of as the ‘central pharmacy’ for NIH, industry and other networks.

This position is responsible for developing, implementing, maintaining and providing leadership, strategic direction and oversight of compliance and training activities for FDA regulated research activities. The position ensures that all clinical research projects are carried out to the standards set forth by the International Conference of Harmonization (ICH) covering Good Clinical Practices (GCP), Good Manufacturing Practices

How to Apply: