Investigational Drug Services Technician Specialist, Shipping and Receiving

Description

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Summary:
The certified technician specialist demonstrates a high level of expertise and skill in a specific aspect of pharmacy practice. The Shipping and Receiving Specialist in Investigational Drug Services is responsible for overseeing the logistics, management, and handling of investigational drugs within the shipping and receiving areas. This includes ensuring the safe and compliant receipt, storage, and distribution of all sponsor-provided shipments, with a focus on maintaining the integrity of medications, ensuring compliance with regulatory requirements, and providing leadership and oversight to shipping and receiving technicians. The pharmacist will manage temperature excursions, monitor chain of custody documentation, communicate tracking with study team contacts, support SOP creation, and provide guidance for any shipment challenges. The Technician Specialist has a high level of autonomy in the role, but consults with the pharmacist when required. The Specialist is the primary trainer of other technicians in the shipping and receiving roles. The Specialist identifies and initiates process improvement activities. The position may be called upon to provide general technician support to the pharmacist. All work is carried out under the supervision of a licensed Pharmacist.

Position will be Day Shift. 8:00 am - 4:30 pm.

This position qualifies for our Pharmacy Technician Incentive Program, which includes $5000 in commitment incentives spread over a two-year period. Payment is made after six months, one year, and two years of employment. Learn more about the Pharmacy Technician Incentive Program here: https://jobs.unchealthcare.org/pages/pharmacy-technician-commitment-incentive-program

Key Responsibilities:

1.Shipping and Receiving Oversight:

oProvides content expertise of a specialty area, specifically shipping and receiving of investigational drugs.

oSupervises the daily operations of the shipping and receiving area, ensuring all incoming and outgoing shipments are handled in accordance with the study protocols, regulatory guidelines, and Good Clinical Practice (GCP).

oCoordinates the receipt of sponsor shipments and ensures proper handling, inspection, and storage of investigational drugs upon arrival.

2.Temperature Excursion Management:

oIs the point of contact for managing and investigating temperature excursions for shipments containing investigational drugs for both General IDS and Oncology IDS.

oHandle temperature excursions and follow through independently. oEnsure that any temperature deviations are documented, assessed for impact, and reported as per IDS SOP and sponsor requirements.

oRequired to communicate with study teams and sponsor contacts regarding temperature excursion events.

oEnsures appropriate corrective actions are implemented in situations where it is required.

oCompletes all sponsor temperature excursion forms. oCommunicates final outcome of temperature excursion to IDS team and maintains documentation.

3.Chain of Custody & Documentation Management:

oEnsure all shipments have proper chain of custody documentation, including verifying that all shipping documents are complete and accurate.

oOversee the maintenance of records for all shipped, received, and stored investigational drugs in compliance with applicable regulations and study requirements.

oSend all chain of custody documentation and courier tracking via email to study teams for both General and Oncology in real time.

4.Communication & Coordination:

oSend tracking information and shipment details to study team contacts for both General and Oncology IDS in a timely and accurate manner.

oCoordinate and communicate with sponsors, couriers, and vendors to ensure timely and compliant shipment of investigational drugs.

oServe as the main point of contact for study teams on any shipping-related inquiries.

5.Supervision and Training:

oSupervise, mentor, and train shipping and receiving technicians to ensure all processes are followed accurately and efficiently.

oProvide support in resolving any challenges or issues encountered during the shipment process, such as delays, damaged goods, or documentation discrepancies.

oEnsure shipping and receiving staff comply with all safety, security, and regulatory guidelines.

oCreate all required training documents and checklists.

6.SOP Creation and Process Improvement:

oResponsible for the creation, review, and updating of SOPs related to shipping, receiving, and handling investigational drugs.

oResponsible for developing and implementing best practices for packaging, shipment processing, and inventory management.

oIdentify opportunities for process improvements and assist in the implementation of enhancements to increase efficiency, accuracy, and compliance.

7.Regulatory Compliance:

oEnsure that all shipping and receiving operations comply with applicable regulations and relevant guidelines.

oStay informed about any regulatory changes or updates that may affect shipping and receiving practices and ensure that the team remains in compliance.

8.Inventory Management and Record-Keeping:

oMonitor and track all investigational drug inventories for both General and Oncology IDS to ensure accurate records are maintained.

oCollaborate with the inventory management team to ensure that stock levels are adequate and that drugs are pulled/quarantined according to expiration dates.

9.Miscellaneous Responsibilities:

oProvide additional support as needed to maintain efficient operations and ensure that all investigational drug shipments are managed in a compliant and timely manner.

oParticipate in audits, inspections, and compliance reviews as needed to ensure all processes are being followed according to established procedures.

oPerforms pharmacy technician operations responsibilities as needed.

Other information:
Education Requirements:
* None required as long as other position qualifications are met.
Licensure/Certification Requirements:
* Registration with the NC Board of Pharmacy unless enrolled in a PharmD program.
*CPhT from PTCB or ExCPT from NHA unless enrolled in a PharmD program.
Professional Experience Requirements:
* One year of pharmacy technician experience required.
Knowledge/Skills/and Abilities Requirements:

Legal Employer: NCHEALTH

Entity: Shared Services

Organization Unit: Pharmacy Investigational Drugs

Work Type: Full Time

Standard Hours Per Week: 40.00

Salary Range: $20.53 - $29.23 per hour (Hiring Range)

Pay offers are determined by experience and internal equity

Work Assignment Type: Onsite

Work Schedule: Day Job

Location of Job: US:NC:Morrisville

Exempt From Overtime: Exempt: No

This position is employed by NC Health (Rex Healthcare, Inc., d/b/a NC Health), a private, fully-owned subsidiary of UNC Health Care System, in a department that provides shared services to operations across UNC Health Care; except that, if you are currently a UNCHCS State employee already working in a designated shared services department, you may remain a UNCHCS State employee if selected for this job.

Qualified applicants will be considered without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

UNC Health makes reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as applicants and employees with disabilities. All interested applicants are invited to apply for career opportunities. Please email applicant.accommodations@unchealth.unc.edu if you need a reasonable accommodation to search and/or to apply for a career opportunity.