Presentation

The pharmaceutical manager is the person responsible for collaborating in any clinical research study in which pharmacy services are required for the management of medication or medical devices under investigation.

Performed tasks

• Control of the investigational product from receipt to dispensing (temperature checks during transport and storage, checking certificates of analysis, verifying that the packaging and identification materials comply with current regulations, ensuring proper storage, etc.).
• Verify that each trial presents all necessary authorizations (favorable opinion from the Clinical Research Ethics Committee/Authorization from the Spanish Agency for Medicines and Medical Devices), and that there is a signed contract between all parties involved, before beginning any activity in the Pharmacy.
• Study the protocol for each trial and understand the work of the Pharmacy Department in each trial, preparing an internal working document summarizing the tasks to be performed.
• Assist clinical trial monitors and/or sponsors throughout their various visits (selection, start-up visit, monitoring, and closure): provide information on internal procedures, provide temperature probe calibrations, provide temperature records, verify Ensure stock is correct, verify accounting for research products, sign documentation, etc.
• Respond to all contact (telephone/email) from clinical trial monitors and/or sponsors and maintain frequent communication with them and the researchers of each trial.
• Establish internal prescription and dispensing conditions with the research team and the clinical trial monitors and/or sponsors.
• Coordinate the investigational product flow for all double-blind trials, with the goal of maintaining the blind at all times.
• Perform manufacturing or packaging of the investigational product when appropriate.
• Prepare preparation documents for the investigational product, as well as the labels necessary for the correct identification of the preparations, following the instructions specified in both the protocol and the trial Pharmacy Manual.
• Make dispensing orders, both to patients directly and to researchers or collaborators, providing all information related to the clinical trial's investigational medication.
• Assist patients or researchers with questions about the clinical trial's investigational medication, as well as inform them about possible interactions with concomitant medications.
• Verify adherence to treatment of patients participating in the trial.
• Perform temperature control of all investigational products as required according to the trial protocol or pharmacy manual.
• Maintain daily probe calibrations (annual calibration).
• Manage and document the destruction of the investigational product when required.
• Control and management of different Interactive Web Response Systems (IWRS).
• Control and maintenance of the pharmacy file for each clinical trial.
• Monitor clinical trial activity related to the investigational product, as well as prepare status reports if required.
• Support to the principal investigator in any audit or visit by the AEMPS that may occur.