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Position Description:

The IDS Pharmacy Technician must be knowledgeable in standard pharmacy practices, including USP<797> and USP<800>, in addition to research and oncology care practices. The IDS Pharmacy Technician advocates for patient safety and protocol integrity, adheres to patient care standards, and communicates effectively to ensure effective conduct of clinical trials and quality patient care.

Minimum Qualifications

Current Pharmacy Technician License (required) in the state where the NEXT Oncology position is located.
Current IV Certification (required) with at least 1 year of mixing experience.
Current Chemotherapy Certification (required) with at least 6 months of mixing experience.

Essential Duties and Responsibilities

Essential and other important responsibilities and duties may include but are not limited to the following:

Protocol Compliance

Enters concomitant medications into the electronic medical record (EMR).
Prepares investigational product (IP) per pharmacy manual instructions and site compounding sheets.

Medication Dispensing and Preparation for Conventional and Investigational Products (IP)

Reviews all chemotherapy labels and compounding instructions for accuracy of dose and dose calculations.
Compounds all IV doses of investigational products and conventional agents, including supportive care medications, cellular therapies, and hazardous compounds.
Have an excellent working knowledge of good clinical practice (GCP), good manufacturing practice (GMP) and all procedures, legislation or national guidelines relating to aseptic preparation (USP<797>) and dispensing of hazardous medication (USP<800>) and clinical trials.
Ensure that IDS services are flexible and responsive to research staff and patient that the services meet patient requirements / needs.

Management of Investigational Product and Drug Accountability

Maintains responsibility for the management of the inventory for protocols, including ordering, receiving and returning IP, as required.
Maintains responsibility for the management of other supplies necessary to perform IP preparation, including, but not limited to IV bags, IV tubing, cleaning products, personal protective equipment (PPE), etc.
Maintains responsibility for ordering conventional agents weekly as needed.
Ensure that correct procedures for receipt of IP and storage of IP are followed.
Maintain appropriate and accurate records for all protocols, including drug accountability, drug receipt, temperature monitoring, expiration / retest dating and staff training, etc.
Ensure that procedures for the return and disposal of IP are current and being followed.
For oral IP: review patient medication diaries and IP returns for accuracy and completeness in conjunction with the treatment room nurses and research coordinators. Document this review and returns in Vestigo. Ensure medication diary is scanned and uploaded into eDOCS.
Ensure that products used in clinical trials are managed according to standard operating procedures (SOPs), Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and any other applicable regulations.
Assist with monitoring visits and answering any monitor queries.

Administrative and Supervisory Responsibilities

Contributes to the development, integration and monitoring of written procedures and workflows covering all aspects of the IDS.
Performs monthly investigational product inventory and documents in Vestigo.
Performs monthly conventional inventory, assists pharmacist in investigating inventory discrepancies / issues.
Provides coverage for other IDS employees when they are out due to illness or scheduled PTO.
Collects and documents workload measurement statistics, provides other data, as required.
Assists the VP of Investigational Drug Services in preparation and review of documentation for audits.

Education Responsibilities

Orients IDS staff, pharmacy residents and pharmacy students to the IDS pharmacy technician role with respect to protocols, as required.
Maintain continuing education requirements to maintain Texas Pharmacy Technician license and protocol compliance training, i.e. GCP / PHRS.

Data and Document Management and Information Technology

Assist in the scanning. review and uploading of protocol documentation into eDOCS.
Upload resume, license(s), certification(s) and training documents into eDOCS.
Vestigo will be utilized as our IP and protocol management software. All IDS staff will become knowledgeable in the use of this program.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Requires full range of body motion including manual and finger dexterity, and eye-hand coordination.
Requires standing and walking for extensive periods of time.
Lifts and carries items weighing up to 40 pounds on a daily basis.
Requires corrected vision and hearing to normal range

Supervision

The IDS Pharmacy Technician reports to the VP of Investigational Drug Services and the IDS research pharmacists at their location, if applicable.

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