To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values-integrity, patient-centered, respect, accountability, and compassion - must guide what we do, as individuals and professionals, every day.
As members of a High Reliability Organization (HRO), every employee should practice CHAMP behavior and strive to make patient safety a top priority. Performs complex Pharmacy-directed technical and clerical functions in support of the pharmacist in the handling of investigational drugs to ensure compliance with pharmacy practices and regulatory standards.
Responsibilities: 1. Performs pharmaceutical distribution, manufacturing, and inventory control duties to ensure compliance with State and Federal regulations as they apply to investigational studies. 1.1. Procures study drug(s) and materials from the research sponsor, drug wholesaler and/or manufacturer in a timely fashion with no more than 3 valid complaints in a 2 month period by investigators and/or 3 interruptions in treatment protocols, as observed by supervisor. 1.2. Receives shipments for storage in the pharmacy in care of the principal investigator completing all required documentation within 4 hours of receipt, as observed by supervisor. Assures accurate and timely disposition of investigational drug supplies upon study termination, as observed by supervisor. 1.3. Maintains adequate drug and material inventory levels 98% of the time, as observed by supervisor. 1.4. Accurately prepares sterile and non'sterile compounded formulation when drug/placebo is not available in required dosage form/unit of issue with no more than four errors per year as observed by supervisor. 1.5. Under the direct supervision of a pharmacist, accurately dispenses investigational drugs to patients and/or study personnel with no more than four errors per year, as observed by supervisor. 1.6. Assists in the coordination of multi'site studies among participating institutions as requested and observed by supervisor. 2. Performs recordkeeping and filing tasks to ensure compliance with State and Federal regulations as they apply to investigational drug studies and to ensure the expeditious retrieval of information so that department personnel can accomplish their responsibilities. 2.1. Maintains inventory records with an accuracy rate of 98% as observed by supervisor. 2.2. Maintains drug dispensing (accountability) records with accuracy rate of 98% as observed by supervisor. 2.3. Maintains study files in an organized fashion as noted by supervisory review. 2.4. Prepares investigational study procedure manuals and/or operating guidelines as requested which required minimal editing by the supervisor. 2.5. Assists the pharmacist in the development of specialized procedures for the extemporaneous preparation, handling, and distribution of investigational study medication. 2.6. Develops study'specific methodologies necessary to document inventory disbursements according to federal regulatory standards. 3. Assists in productivity and activity monitoring within the IDS in order to help ensure the goals of the service are met. 3.1. Accurately collates IDS work volume statistics for the quarterly/annual report within five days of completion of each quarter as observed by supervisor. 3.2. Prepares invoices for manufacturing services rendered to investigators within five days of the completion of each quarter as observed by supervisor. 3.3. Accurately inputs information required into the computer on a daily basis as observed by supervisors. 4. Follows established safety precautions and procedures in the performance of all duties in order to ensure a safe environment. 4.1. Operates the following equipment in a safe manner following all procedures as reviewed at initial orientation, with no more than 2 non'serious variances in this evaluation period: laminar flow hoods (horizontal), unit dose strip packaging machine, mixer/blender, hot plate, class A balance syringe filling apparatus, typewriter and computer video display terminal and printer. 5. Exercises professional communication skills in support of the efficient utilization of the Investigational Drug Service. 5.1. Serves as a principal departmental liaison with physician researchers, nurses, and hospital clients. 5.2. Serves as a hospital liaison with pharmaceutical industry research associates, regulatory agencies, and independent laboratories. 6. Assists with employee orientation and training of new employees to ensure through understanding of IDS policy and procedures. 6.1. Conducts training and orientation of pharmacy technicians to the IDS. 6.2. Completes lecture or lab session for department technician training program, meeting all deadlines and quality expected for all lectures as determined by the coordinator of the program. 6.3. Assists the department's staff development coordinator in providing continuing education programs to the pharmacy technicians. 6.4. Conducts necessary ongoing training of pharmacy technicians for all new inpatient investigational studies, including the storage, handling and distribution of study medications.
High school diploma required. Successful completion of academic or military pharmacy technician training course
and certification by the national Pharmacy Technician Certification Board (PTCB) strongly preferred. College degree
Minimum of three and a half (3 1/2) years pharmacy technician experience at Yale?New Haven Hospital pharmacy, with a minimum of one (1) year as Technician II. Must have demonstrated performance at the very good level.
Current registration as a Pharmacy Technician in the State of Connecticut as outlined by the Dept. of Consumer
Must be registered or eligible for registration as a Pharmacy Technician in the State of Connecticut as outlined by
the Dept. of Consumer Protection. Proficiency in mathematical calculations; accuracy; problem solving; attention to
detail; knowledge of computer applications including word processing and spreadsheets; ability to learn quickly in a
fast-paced environment; ability to learn or perform pharmaceutical compounding, repackaging and labeling including
manipulation of raw drug products using appropriate technique: ability to work with computer and technology
equipment including the ability to perform basic troubleshooting functions. Must be able to prioritize competing
demands, work independently, show flexibility and teamwork. Demonstrate good communication skills to customers
and team members
The individual in this position is held accountable to the Manager,. Pharmacy Operations for performing all duties
accurately, efficiently, and according to departmental, hospital and professional standards. Must maintain State of
CT registration. Must meet any and all demands for service in a timely and efficient manner. Must successfully
complete all hospital and departmental competency validation and quality assurance tests, including but not limited
to, weekly audits for drug dispensing accuracy
Incumbent held accountable for the accurate and timely performance of investigational drug distribution activities in accordance with acceptable hospital practices and Federal and State regulations. Must maintain dispensing (accountability) records. Responsible for collating work volume statistics, and for preparation of billing invoices. Controls investigational drug inventories. Serves as operational liaison between inpatient pharmacy services and the IDS.
Performs tasks independently under the supervision of a pharmacist. Performs work commensurate with a high level of cooperation and mutual respect towards other employees. Responsible for planning activities around projected workload. Assists with the specialty training of pharmacy technicians and orientation of pharmacists. Uses independent judgment in controlling the movement of investigational drug inventory. Assists in making decisions which affect the daily operations of the IDS. Provides creative input into investigational study procedure manuals. Applies problem'solving skills aimed at innovative ways of handling investigational drug studies. Works in the specialty area (IDS) 100% of scheduled hours.