Job location: Smilow Center for Translational

Employment Type: Full-time
Posted data: 2019-08-16
Req: JR00004524
University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.

Posted Job Title

Clinical Research Pharmacy Assistant

Job Profile Title

Laboratory Resources Coordinator

Job Description Summary

The Clinical Research Pharmacy Assistant is responsible for the preparation of and accountability for medications dispensed to subjects in clinical research trials. The highest degree of accuracy and attention to detail is expected of this position. Additionally, the technician is responsible for management of drug and supply inventories and periodic reordering to ensure medications are available when required; compliance with regulations, policies and study protocols. Other key accountabilities include but are not limited to: assisting visitors, research personnel and study participants; active participation in and assistance with audits and inspections; compliance with departmental and institutional policies; and collaboration and cooperation with other members of the study team as needed. This position is contingent on funding.

General requirements of the candidate:
•Accuracy and attention to detail
•Ability to handle stressful situations and meet deadlines
•Prior research experience required (clinical preferred, non-clinical considered)
•Strong customer service focus
•Prior pharmacy experience preferred, sterile admixture experience preferred
•Ability to work flexible hours, including rotating weekends, occasional overtime to meet operational needs
•Strong self-initiative while working as part of a team

Job Description

• Prescriptions are filled and dispensed accurately and timely

• Prescription filling includes correct medication, study, correct kit or lot number, correct patient, etc

• All transactions are thoroughly and properly documented; both electronic and paper records are complete and legible as applicable to the individual activit
• Study-specific written procedures and sponsor instructions are followed with every dispense; variance from these procedures is brought to the attention of a pharmacist immediately
• Discrepancies are noted, brought to the attention of a pharmacist and then investigated, documented and/or brought to resolution.

• Sterile products are prepared accurately and safely
• Sterile admixture certification and chemotherapy certification are completed successfully within the first 30 days after hire, routine re-certification is completed per established department schedule
• Dose calculations are accurate and clearly documented
• Measurements are performed accurately and using appropriate tools or materials
• Sterile products are manipulated in a safe manner following strict aseptic technique and in compliance with USP<797> standards

• Inventory management, recordkeeping and reordering
• Supplies that require reordering are ordered in proper quantities at the appropriate time
• Inventory checks for assigned areas are completed and documented per department procedure
• Discrepancies are noted, brought to the attention of a pharmacist and then investigated, documented and/or brought to resolution.
• Patient ‘returns’ are checked routinely and documented thoroughly and accurately
• Technician sets up for audits and monitoring visits, reviews documentation beforehand, assists in answering auditor’s questions and seeks pharmacist assistance when necessary.
• Disposal/destruction of medication follows policy and is documented completely, accurately and legibly.

• Compounding, manufacturing and repackaging of products for clinical trial use
• Follow safe practices in the handling and manipulation of raw materials, chemicals and other products used in the preparation of medications for clinical trial use
• Demonstrate proficiency in the use of equipment such as balances, mixers, centrifuges, heat presses, capsule fillers, pipettes, microscopes, etc.
• Maintain complete, accurate and thorough documentation in the preparation of all products; batch records are completed in full, test results are accurately recorded, product is reserved until QA review
• Products are prepared on a timely basis as per the needs of patients and individual clinical trials

• Customer service and communications
• Greet visitors/customers and answer phones promptly, professionally, respectfully, with a helpful customer service-focused approach
• Effectively triage and resolve communications related to subject visits, appointment scheduling and sponsor/monitor requests. Direct communications that require pharmacist input to the appropriate staff member.
• Communicate effectively and timely with coworkers and customers
• Take proper and complete messages
• Follow-up on incomplete tasks, stat items and outstanding issues to ensure resolution

• Compliance with policies, regulations and guidelines
• Follow department policies and related institutional policies.
• Maintain active GCP and HSP (Human Subject Protection) training and any training required by either UPHS or the University of Pennsylvania
• Follow applicable national standards, including USP<795>, USP<797>, USP<800>, GCP, GMP and others.

• Laboratory testing and product release
• Technician is able to identify when laboratory testing of products is required prior to use
• When required, samples are withdrawn under appropriate conditions for testing use
• Technician maintains awareness of testing that is performed within IDS, communicates with Director and laboratory manager when testing is required
• With proper required training, performs tests under guidance of laboratory manager or designee
• Confirms that all testing is complete and that product has been released for use.

• Other duties as assigned

Qualifications:

Bachelor's Degree and 1-2 years experience or equivalent combination of years and experience required.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$20.00 - $36.00

Affirmative Action Statement 
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.

Special Requirements 
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.