Research Pharmacy Technician (Investigational Drug Service)

Children’s Hospital of Philadelphia•Philadelphia, PA

3d•$25 - $31•Onsite

About The Position

Reporting to the IDS Pharmacy Supervisor, the IDS Pharmacy Technician assists in various pharmacy activities under the supervision of a licensed pharmacist and is responsible for providing technical support of clinical trial protocols by managing clinical trial inventory, preparing and distributing investigational products according to the protocol, and enforcing relevant standard operating procedures (SOPs) to maintain compliance with applicable regulations. Sterile Products Pharmacy Technicians maintain high standards for the quality and controls of processes, components, and environments with the skill and knowledge of practices to prevent harm to patients due to 1. Microbial contamination, 2. Excessive bacterial endotoxins, 3. Variability in the intended strength of correct ingredients 4. Unintended chemical and physical contaminants, and 5. Ingredients of inappropriate quality in compounded sterile preparations (CSPs). The incumbent must demonstrate the knowledge and skills necessary to provide care appropriate to this unique patient population and support the mission and vision of CHOP and CHOP's Research Institute.

Requirements

Must be registered as a Pharmacy Technician in Pennsylvania - Required
High School Diploma / GED Required
Basic computer skills including use of Windows operating system and word processors (Required proficiency)
Calculation skills (Required proficiency)

Nice To Haves

Certified Pharmacy Technician (CPhT) - Pharmacy Technician Certification Board (PTCB) - upon hire - Preferred
Certified Pharmacy Technician (CPhT) - National Association for Health Professionals (NAHP) - upon hire - Preferred
Technical Diploma Pharmacy Technician Program Preferred
Sterile products compounding Preferred
Investigational Drug Service experience Preferred

Responsibilities

Provides technical and operational support of clinical trial protocols and conforms to the IDS Policy and Procedures for the appropriate and efficient preparation and utilization of investigational products at CHOP
Prepares and distributes investigational product and other necessary medications and supplies according to the protocol and pharmacy investigational drug data sheet, accurately, in the appropriate quantity and at the time the product is needed
Maintains clinical trial inventory according to protocol requirements and IDS SOPs
Maintains proper functioning of equipment and systems used by IDS
Responds to inquiries from internal staff (i.e., pharmacy staff and study coordinators) and external personnel (i.e., monitors and auditors)
Responsible for accurately preparing patient-specific and non-patient specific doses by ensuring that the compounded sterile products (CSP) are accurately identified, measured, reconstituted, diluted, mixed, sterilized, packaged, labeled, and stored.
CSPs are prepared aseptically, accurately, and safely in accordance to USP 797, USP 800 and CHOP Pharmacy SOPs
Only medications and ingredients with correct identity, quality and purity are used in the preparation of CSPs
Ingredients, medications and CSPs are appropriately stored to preserve the sterility and strength until the manufacturer expiration date or CHOP assigned beyond-use date (BUD)
Equipment, devices, and fixtures are routinely cleaned, appropriately maintained, and used for accuracy and effectiveness for their intended use as per CHOP SOP
Ensure floors are free of debris and dust. Floors, sink, and all surfaces are cleaned daily as per CHOP SOP
Labels products with proper information and appropriately assigns the BUD as per CHOP SOP
Prior to dispensing, ensures all prepared CSPs are verified by a pharmacist for accurate identity, measure, reconstitution, dilution, mixture sterility, packaging, labeling, and storage at the recommended temperature.
CSPs are prepared within allotted cycle times to ensure that the turnaround time for all first-doses and non-STAT medication orders does not exceed 1 hour and the turnaround time for all STAT medication orders does not exceed 15 minutes
Responsible for compliance to all federal, state, and department standards and regulations for sterile product compounding- USP797, USP800, CMS Conditions of Participation, FDA Compounding Guidance and TJC standards
Completes initial aseptic technique training and passes competency test
Reviews all CHOP Pharmacy SOPs related to CSP preparation and practices
Completes electronic competency with score ≥ 90%
CSP microbial contamination risk levels
Beyond Use Dating
Environmental Quality and Control
ISO Class Air Sources, Buffer Area and Ante Area
Personnel Cleaning and Garbing (Non-Hazardous and Hazardous)
Cleaning/Disinfection Procedures (Non-Hazardous and Hazardous)
Complete three consecutive cycles of Non- Hazardous and Hazardous PPE donning/doffing with zero (0) standard work variances including three gloved fingertip test samples with zero (0 CFU) growth results after a 3 day incubation
Completion of aseptic media fill practical evaluation with zero (0) standard work variances including test media samples with zero (0) CFU growth results after a 14 day incubation
Completes annual/semi-annual aseptic technique recertification and passes competency test
Completes electronic competency with score ≥ 90%
Completes one cycle of Hazardous and Non- Hazardous PPE donning/doffing with zero (0) standard work variances including one gloved fingertip test samples with zero (0 CFU) growth results after a 3 day incubation
Completion of aseptic media fill practical evaluation with zero (0) standard work variances including test media samples with zero (0) growth results after a 14 day incubation
Compliant to all dress code and PPE maintenance and associated CHOP Pharmacy SOPs
No make-up or head/neck/wrist jewelry can be worn
Appropriate attire in Sterile Product areas:
- Scrub sets
- Short-sleeved, collarless shirts
- Full-length pants
- Skirt or dress – NOTE: Stockings/hose MUST be worn with skirt or dress
- Socks covering above ankle
Compliant to all aseptic technique work practices and associated CHOP Pharmacy SOPs
Cleaning, disinfection, and sanitization of laminar air flow hood (LAFH), equipment, and room at frequency defined USP 797 and CHOP SOPs
Cleaning all products and supplies with sporicidal cleaning/disinfecting agent prior to introduction across line of demarcation
Sanitizing all products and supplies with sterile 70% isopropyl alcohol prior to introduction into LAFH
Sanitizing gloves with 70% isopropyl alcohol prior to introduction into LAFH for dose preparation
Maintenance of “first air” to all critical sites during dose preparation
Maintain all required documentation for clean room operations including but not limited to:
- Daily LAFH and work surface cleaning
- Weekly sporicidal LAFH and work surface cleaning
- Monthly sporicidal zone cleaning and inspection
- Daily air pressure differential monitoring
- Weekly eye wash hose functionality
Pharmacy products are distributed accurately, with the appropriate quantity and at the time the product is needed
Kanban Inventory system is adhered to 100% of time.
Maintains and organizes inventory supply in a manner which minimizes inventory storage cost, wastage, and stock-outs. Ensures inventory is rotated properly, stored in appropriate conditions and location with 100% accuracy.
Complete monthly medication expiration dating assignments in a timely manner. Identify and reorder expired medications inventory and ensures that stock is stored in accordance with manufacturer requirements.
Assures the proper replacement of prescription drugs to stock upon requisitions from various departments of the hospital either manually or through the Pyxis System.
Ensures the proper documentation and secure storage of controlled substances and investigational products.
Documents every transaction completely and accurately.
No generation of discrepancies in the C2 Safe, Pyxis Medstation, or Inventory Logs.
Ensures the destruction of returned controlled substance continuous medication infusions.
Ensures secure storage of narcotics and other controlled substances on a regular basis. Maintains inventory records on narcotics and other forms of drugs as required by law.
Performs inventory counts of controlled substances on safes as per policy and procedures.
Achieve patient safety and satisfaction through the use of LEAN principles:
5S
Elimination of Waste
JIT
Stand Work
Quality
Promotes and Complies with Standardized Procedures.
Promotes and Complies with Standard Work.
Identifies “waste” in ownership process and recommends solutions for implementation.
Corrects abnormal conditions.
Participates in hospital and departmental Continuous Quality Improvement (CQI) activities.
Utilizes LEAN Principals to analyze and resolve problems in a systematic manner.
All improvement must be made in accordance with the scientific method
Participation in departmental RPI
Works OT to allow co-workers to participate in department RPI