Pharmacy Technician

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Pharmacy Records KMCR Full Time Dallas, TX, US

The Pharmacy Technician will be responsible for assisting with the day-to-day operations of clinical trials, and manage preparation and dispensation of compounded sterile investigational products for the pharmacy to facilitate the efficient operation of the Clinical team. This person must possess competencies in USP, demonstrate proper aseptic technique, and have a strong background in sterile IV compounding. They will attend meetings and events to promote studies, work closely with Clinical team to assist and cross train, as well as document and report on the daily operations of pharmacy activities and status.

This person must be able to understand clinical research priorities and establish a workflow to complete all required activities in a timely manner. This position is responsible for a broad range of duties involving confidential information.

The Pharmacy Technician must be organized, excel at multitasking, detail-oriented, an excellent written and oral communicator, and be able to provide high-quality patient care. This person will collaborate very closely with other members of the team, external vendors, and therefore must be highly collaborative, goal-oriented, flexible, and communicative. An ideal candidate will be responsive, thoughtful, empathetic, self-motivated, and a team-player. This role reports directly to the Site Director.

• Preparation of Investigational product, including sterile IV compounding.
• Comply with proper USP standards.
• Receive investigational product (IP) shipments on site.
• Account for all shipment contents and complete required documentation.
• Confirm in sponsor assigned vendor portal (example: IWRS/IXRS/EDC) shipment received or notify sponsor that shipment was received if there was no IWRS/IXRS system.
• Document shipment and its contents on the IP logs.
• Upload monthly temperature logs within the first week of the month for individual or multiple sites
• Assessing, documenting, and reporting temperature excursions as they occur to include completion of any excursion paperwork provided by the sponsor
• IP dispensing and return accountability from clinical team
• Double verification of IP dispensation and returns.
• Manage Pharmacy Binder on CRIO eREG
• Host unblinded routine monitoring visits
• Daily reconciliation of applicable pharmacy logs
• Maintain pharmacy organization and current IP supply
• Coordinate routine temperature monitor calibrations
• Complete manual temperature recording as applicable
• Perform IP administration
• Orders supplies as needed from local pharmacy or selected vendors if applicable
• Maintains pharmacy supply inventories
• Ensures appropriate temperature conditions for pharmacy and pharmacy equipment (i.e. refrigerators and freezers)
• Provides training to support staff members
• Coordinates the return of IP with Sponsor/CRO
• Calls in prescriptions on behalf of PCR for patients if applicable to site process
• Labels IP for internal tracking
• Provides subjects with IP instruction and education
• Collaborate and cross-train with Lab and Clinic personnel if applicable at site
• Always maintain subject and document confidentiality, understand, and comply with the appropriate sponsor requirements and regulations which include the Food and Drug Administration, good clinical practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures
• Willing to travel to provide additional support to other sites as needed

• Create and maintain reports and/or spreadsheets as requested
• Assist with maintaining study documents and electronic regulatory documents
• Schedules and coordinates meetings with sponsors for purposes of review of pharmacy related items alongside Clinical Research Project Manager

Duties, responsibilities, and activities may change, or new ones may be assigned at any time.

• High School Diploma or general education degree (GED)
• Licensed Pharmacy Technician in The State of Texas
• 2 years Pharmacy Technician experience
• Proficient in all Microsoft Office applications
• Demonstrated organizational skills and outstanding time management, including keen attention to detail with the ability to track multiple projects at one time
• Strong…