Pharmacy Assistant

Duties and Responsibilities

• 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.
• Assess, document, and report temperature excursions as they occur to include completion of any excursion paperwork provided by the sponsor.
• 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.
• Carefully coordinate routine temperature monitor calibrations.
• Complete manual temperature recording as applicable.
• Order 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.
• Collaborates and cross-trains with Lab and Clinic personnel if applicable at site.
• Always maintains 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.

Qualifications, Education & Experience

• A High School Diploma or general education degree (GED).
• Medical Assistant with 2 years of front and back-office experience or 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 written and oral communication skills.
• Knowledge of basic medical terminology.
• Possess impeccable integrity and personal and professional values that are consistent with PCR’s high standards and mission.
• Comply with the company policies, code of ethics, and guiding values always.
• Proficient in English and Spanish preferred.