Pharmacy Technician III, Investigational Drugs

UNIVERSITY OF MARYLAND MEDICAL SYSTEM; Baltimore (MD); On-site; USD 31,092 - 43,518; Full time

Benefits offered by this job

Sign-on bonus

Shift differentials

Job summary

JobRx, Inc. is seeking a Pharmacy Technician to support the Investigational Drug Service (IDS).

Under supervision, you will assist with drug preparation, dispensing, inventory control, and QA activities related to IDS, and serve as a resource to hospital staff regarding investigational drug policies and procedures. You will assist with preparation of study documents and the dispensing of study drugs, label medications, maintain drug inventories, and help with protocol documentation and sponsor

Qualifications

• High school diploma or equivalent (GED) is required.
• Certification as a Certified Pharmacy Tech (CPhT) required.
• Maryland BOP registration required.

Responsibilities

• Assist with preparation of study documents and the dispensing of study drugs.
• Prepare doses of study drugs upon request of an authorized physician and/or pharmacist.
• Prepare scheduled doses and prescriptions prior to scheduled visits to ensure smooth clinical operations.
• Deliver drugs to clinical patients and pharmacy locations.
• Assist with the maintenance of treatment schedules.
• Assist with protocol review and preparation of protocol documents with supervision from IDS specialists and IDS supervisor.
• Maintain control of study drug inventories located within IDS areas throughout the Dept. of Pharmacy.
• Receive shipments of investigational drugs and review against accompanying receipt for accuracy.
• Label all study medications according to state, federal and sponsor standards and properly store incoming clinical trial materials.
• Accurately record dispensing activities and maintain records of Clinical Trial Materials per FDA regulations.
• Reorder drugs from sponsors and complete stock requisitions for replacement medications.
• Conduct quality assurance inventories not more than 30 days apart and reconcile discrepancies.
• Assist with final processing of patient returns and proper destruction of study medications.
• Maintain files of all investigational drug protocols and required FDA information.
• Coordinate monitoring visits and prepare necessary documentation for sponsors.
• Serve as a resource to pharmacy personnel regarding investigational drug procedures and sponsor requirements.
• Train pharmacy technicians in IDS procedures and drug documentation.
• Maintain IDS drug information notebooks and update monthly.
• Assist with billing/collection of research-related fees under supervision.
• Communicate problems to supervisor or pharmacist for resolution.
• Observe policies and QA programs; perform monthly IDS area inspections and document corrective actions.
• Assist in care and maintenance of department equipment; ensure proper functioning of refrigerators/freezers.
• Perform routine maintenance; coordinate with Facilities/Biomedical Engineering for complex tasks.
• Clean and change filters in Laminar Flow Hoods and cabinets using aseptic technique; document actions per QA criteria.

Skills

Pharmacy principles

Verbal and written communication

Education

High school diploma

CPhT certification

Maryland BOP registration

Job description

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.

Principal Responsibilities and Tasks

1. Assists the pharmacist with the preparation of study documents and the dispensing of study drugs and supplies.
2. Prepares doses of study drugs upon request of an authorized physician and/or pharmacist.
3. Prepares scheduled doses and prescriptions prior to scheduled visits to ensure smooth clinical operations.
4. Delivers drugs to clinical patients and pharmacy locations.
5. Assists with the maintenance of treatment schedules.
6. Assists with the protocol review and preparation of protocol documents with supervision from the IDS specialists and IDS supervisor.
7. Maintains control of study drug inventories located within the Investigational Drug Service areas throughout the Dept. of Pharmacy.
8. Receives shipments of investigational drugs and reviews against accompanying receipt to ensure accuracy.
9. 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.
10. Accurately records dispensing activities and maintains records of Clinical Trial Materials in accordance with FDA regulations.
11. 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.
12. Conducts quality assurance inventories for each study, at intervals of not greater than 30 days. Verifies the accuracy of the dispensing records and reconciles discrepancies according to the department's quality assurance policy.
13. Assists with the final processing of patient returns and ensures proper procedures are followed for the return and final destruction of study medications.
14. Maintains files of all investigational drug protocols and FDA required information.
15. 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.
16. Serves as a resource to pharmacy personnel regarding investigational drug procedures and sponsor requirements in the proper handling and dispensing of study drugs.
17. 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.
18. Maintains IDS drug information notebooks and updates as required, at least monthly.
19. Assists with billing and/or collection of pharmacy research related fees with supervision from the IDS specialists and IDS supervisor.
20. Communicates problems to the supervisor or pharmacist for resolution, as necessary.
21. 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.
22. 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.
23. Ensures proper functioning of pharmacy refrigerators and freezers. Checks for adequate temperature levels and that cleaning standards are maintained according to departmental procedures.
24. Performs routine maintenance; contact Facilities Maintenance or Biomedical Engineering to perform more complex maintenance duties.
25. 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.

Knowledge, Skills and Abilities

1. General knowledge of generally accepted pharmacy principles, practices and procedures, pharmaceutical generic and trade names and general mathematics is required. Knowledge of general PC computer software applications such as spreadsheet, database, word processing and data entry is required.
2. Highly effective verbal and written communication skills are necessary in order to work with medical, nursing and various allied health staff in order to successfully provide optimal patient care.

Master of sterile compounding technique preferred.

Education and Experience

1. High school diploma or equivalent (GED) is required.
2. Certification as a Certified Pharmacy Tech (CPhT) required.
3. Maryland BOP registration required.
4. Three years experience as a Pharmacy Technician, or equivalent experience in a research/clinical environment, is required.

Additional Information

All your information will be kept confidential according to EEO guidelines.

Compensation

• Pay Range: $22.57-31.59
• Other Compensation (if applicable): Eligible for shift differentials when applicable, eligible for up to $1200 sign‑on bonus
• Review the 2025-2026 UMMS Benefits Guide

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