The University of Texas MD Anderson Cancer Center
Location
Houston, TX | United States
Job description
SUMMARY
In compliance with FDA, United States Pharmacopeia, Texas Department of State Health Services Radiation Control Program, and Texas State Board of Pharmacy rules and regulations, provides supervision for CRF Nuclear Medicine Technician (NMT) and monitors area to ensure a safe working environment. Participates in preparation and release of hyperpolarized contrast agents and provides guidance to the NMT regarding same. This position requires the ability to successfully manage the dispensing , compounding, and quality control of radiopharmaceuticals. Ensures safe and reliable unit dose dispensing of both FDA-approved and investigational radiotracer imaging agents.
MISION STATEMENTThe mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation, and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.
JOB SPECIFIC COMPETENCIES Radioisotope Handling and Dispensing • Legally operates the radiopharmacy per Texas State Law and oversees all radiopharmacy related activities.
• Applies principles and practices of pharmacy and radiochemistry to prepare and dispenses unit doses of radiopharmaceuticals used for patient diagnosis and therapy.
• R eceives radiopharmaceutical prescriptions from physicians and reviews prescriptions to determine the suitability of a particular radiopharmaceutical for intended use.
• Utilizes knowledge of radiopharmaceutical preparation and principles of drug biodistribution to verify that specified radioactive substances and reagents will give desired results in examination or treatment procedures.
• Calculates volume of radioactive pharmaceutical required to provide patients with desired level of radioactivity at prescribed time, according to established rates of radioisotope decay.
• Follows all radiopharmacy procedures, extemporaneously compounds radiopharmaceuticals and non-radioactive drugs not available from commercial sources to prepare various investigational radiopharmaceuticals.
• Provides complex radiolabeling services (including radiolabeling of peptides for diagnostic and therapeutic applications).
• Dispatches radiopharmaceutical materials to external purchasers in compliance with the requirements for lawful transport of radioactive materials by air or road.
• Assays prepared radiopharmaceuticals, using measuring and analysis instruments and equipment, such as ionization chamber, pulse-height analyzer, and radioisotope dose calibrator, to verify rate of drug disintegration and to ensure that patient receives required dose.
• Works with NPT(s) and/or Staff Radiopharmacist to prepare fluid paths and aseptically prepare final product syringes for use in the SpinLab.
• Understands quality control release criteria for hyperpolarized agents produced by the SpinLab. Signs off on release of dose as needed.
• Assist with the development of SOPs, CMC preparation, etc. to help meet the deliverables listed on executed Statements of Work.
• Attends site initiation and/or investigator orientation meetings for clinical trials in which the CRF is involved.
• Trains on new pharmacy related IND radiopharmaceuticals to ensure proper preparation, dispensing, and quality control is completed per protocol.
• Supports the Director of the CRF in the preparation of the annual budget. Proposes solutions to increase the cost efficiency associated with radiopharmacy operations.
• Maintains accountability for stewardship and fiscal operation of the radiopharmacy.
• Develops and recommends new pharmaceutical procedures and techniques; prepares reports and analyses setting forth progress, adverse trends, and appropriate recommendations or conclusions.
• Maintains and calibrates a variety of chemistry and scientific instrumentation.
• Develops systems for disposal, distribution, compounding, preparation, sterility assurance, and quality control of radiopharmaceuticals.
• Develops systems for the control against theft or diversion of radiopharmaceuticals or their components.
• Advises the Director of the CRF regarding administrative/operational concerns as they arise. Proposes solutions to same for consideration.
• Consults with the Director of the CRF to:
(1) establish policies for procurement of prescription drugs and devices and other products dispensed from the Class B pharmacy;
(2) establish policies and procedures for the security of the prescription department including the maintenance of effective controls against the theft or diversion of prescription drugs;
(3) if the pharmacy uses an automated pharmacy dispensing system, reviewing and approving all policies and procedures for system operation, safety, security, accuracy and access, patient confidentiality, prevention of unauthorized access, and malfunction;
(4) provide the pharmacy with the necessary equipment and resources commensurate with its level and type of practice; and
(5) establish policies and procedures regarding maintenance, storage, and retrieval of records in a data processing system such that the system is in compliance with state and federal requirements.
Documentation and Record Keeping • Maintains compliance with the established regulations for radiopharmacy operation, including, but not limited to:
- T exas Department of Health Services Radiation Control Program
- US Pharmacopeia
- Food and Drug Administration
- Texas Board of Pharmacy
- Drug inventory, drug accountability, dispensing and inventory control
- The prescription drug ordering process including prescription generation and traceability
- Pharmacy dispensing and dispensed drug final verification checks
- M.D. Anderson internal pharmacy guidelines
• Performs weekly and monthly Quality Assurance procedures.
• Assists with Out of Specification (OOS) event investigations and proposes subsequent plans of action.
• Works with the Director and direct reports to document all radiopharmaceutical product complaints received by the CRF. Assists with any investigation(s) as stipulated by Director.
• Actively participates during inspections by the Texas BOP, FDA or other regulatory agencies. Works with Director and the Drug Manufacturing Quality Specialist to draft audit response(s) with/without a Corrective Action Plan.
Radiopharmacy Safety • Monitors assigned area for environmental deficiencies such as lighting/electrical needs or breech of exit/entrance. Notifies Director of occurrences.
• Ensures that radiopharmaceutical personnel wear appropriate personnel protective equipment (PPE) when working in hazardous controlled areas.
• Ensures that the radiopharmacy is clean, organized, and safe for personnel. Directs NMT in cleaning efforts and/or assists as needed to maintain appropriate cGMP environment.
• Limits access only to those by qualified/required personnel.
• Works to ensure minimal radiation exposure and compliance with the "As Low as Reasonably Achievable" (ALARA) principle.
• Responsible for ensuring radiation detection equipment is worn by personnel working in the Radiopharmacy.
• Performs/documents daily dosimeter checks.
• Supervises radioactive/biohazard waste segregation and disposal and completion of related documentation.
• Ensures appropriate storage and handling of radiation detecting equipment.
• Assists with Out of Specification (OOS) event investigations and proposes subsequent plans of action.
Human Resource Oversight • Leads by example in behavior and work ethic.
• Assures all pharmacy personnel are trained appropriately through education and evaluation.
• Provides daily supervision of the Staff Radiopharmacist(s) and NPT(s). Organizes, co-ordinates, and/or appropriately delegates daily activities to ensure appropriate resource allocation and to meet the needs of CRF Stakeholders.
• Monitors area workflow to assure that all tasks are performed in a timely manner. Works with the Director of the CRF to address issues of noncompliance.
• Plans and conducts meetings with subordinates to ensure compliance with established procedures, to implement new policies, and to keep employees abreast of current changes and standards.
• Establishes regular, recurring meeting times with direct report(s) to provide timely feedback on performance. Conducts coaching/counseling sessions as needed to achieve positive outcomes related to issues/concerns. Maintains documentation of meetings for future reference if needed.
• IN collaboration with the Director, completes Performance Evaluations for direct reports per institutional guidelines.
• Ensures direct reports obtain required continuing education. Provides training/arranges in-services to integrate new procedures into daily practices.
• Identifies opportunities for professional growth of direct report(s). Covers routine tasks so that direct report(s) can attend identified training.
Other Duties As Assigned Required education: Bachelor's of Science degree in Pharmacy or Pharm. D. degree from an accredited college of pharmacy.
Required experience: Five years of experience as a Nuclear Pharmacist.
Required license: Current license to practice pharmacy in the State of Texas.
It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law. http://www.mdanderson.org/about-us/legal-and-policy/legal-statements/eeo-affirmative-action.html
Additional Information
- Requisition ID: 166095
- Employment Status: Full-Time
- Employee Status: Regular
- Work Week: Days
- Minimum Salary: US Dollar (USD) 128,000
- Midpoint Salary: US Dollar (USD) 160,000
- Maximum Salary : US Dollar (USD) 192,000
- FLSA: exempt and not eligible for overtime pay
- Fund Type: Soft
- Work Location: Onsite
- Pivotal Position: Yes
- Referral Bonus Available?: No
- Relocation Assistance Available?: Yes
- Science Jobs: No
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