Job Requirements Under general supervision, performs and assists with the management of research protocols to include drug preparation, dispensing, inventory control, and various quality assurance activities related to the Investigational Drug Service (IDS). Serves as a liaison with sponsor representatives and serves as a resource to hospital and pharmacy personnel regarding investigational drug policies and procedures.
The following statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all job duties performed by personnel so classified. Assists the pharmacist with the preparation of study documents and the dispensing of study drugs and supplies.
Prepares doses of study drugs upon request of an authorized physician and/or pharmacist. Prepares scheduled doses and prescriptions prior to scheduled visits to ensure smooth clinical operations. Delivers drugs to clinical patients and pharmacy locations.
Assists with the maintenance of treatment schedules. Assists with the protocol review and preparation of protocol documents with supervision from the IDS specialists and IDS supervisor. Maintains control of study drug inventories located within the Investigational Drug Service areas throughout the Dept. of Pharmacy.
Receives shipments of investigational drugs and reviews against accompanying receipt to ensure accuracy. Labels all study medications according to state, federal and sponsor standards (such as name of drug, amount, dose, date, expiration date, caution, prescribed amount, method of administration, physician’s name, usage instructions, that it is a drug “for investigational use only”). Properly stores incoming clinical trial materials regarding study, temperature, and location.
Properly documents receipt and returns acknowledgement forms to sponsor in accordance with all FDA regulations. Accurately records dispensing activities and maintains records of Clinical Trial Materials in accordance with FDA regulations. Reorders drugs from sponsors in accordance with sponsors’ stated time needs.
Completes appropriate pharmacy stock requisitions forms for replacement of medications that are obtained commercially. Conducts quality assurance inventories for each study, at intervals of not greater than 30 days. Verifies the accuracy of the dispensing records and reconcile discrepancies according to the department’s quality assurance policy.
Assists with the final processing of patient returns and ensures proper procedures are followed for the return and final destruction of study medications. Maintains files of all investigational drug protocols and FDA required information. Assists with the coordination of monitoring visits with sponsor representatives.
Completes quality assurance inventory, makes all drug supplies readily available, and copies all necessary documentation prior to scheduled visits. Serves as a resource to pharmacy personnel regarding investigational drug procedures and sponsor requirements in the proper handling and dispensing of study drugs. Trains pharmacy technicians in the daily procedures and logistics of the IDS, the handling of study drug documentation and the orientation to the IDS layout.
Maintains IDS drug information notebooks and updates as required, at least monthly. Assists with billing and/or collection of pharmacy research related fees with supervision from the IDS specialists and IDS supervisor. Communicates problems to the supervisor or pharmacist for resolution, as necessary.
Observes established department policies, procedures and quality assurance programs, safety, environmental and infection control standards. Performs monthly inspections of IDS work area; completes inspection reports, documents problems observed and corrective actions taken as necessary. Assists in the care and maintenance of department equipment and supplies such as Laminar Flow Hoods, biological safety cabinets, computers, printers, packaging equipment and manufacturing equipment.
Ensures proper functioning of pharmacy refrigerators and freezers. Checks for adequate temperature levels and that cleaning standards are maintained according to departmental procedures. Performs routine maintenance; contact Facilities Maintenance or Biomedical Engineering to perform more complex maintenance duties.
Thoroughly cleans and changes filters in Laminar Flow Hoods and biological safety cabinets using aseptic technique. Documents all actions relative to established total quality management criteria according to established procedure. Work Experience Education and Experience High school diploma or equivalent (GED) is required.
Certification as a Certified Pharmacy Tech (CPhT) required. Maryland BOP registration required. Three years experience as a Pharmacy Technician, or equivalent experience in a research/clinical environment, is required.
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