J0B SUMMARY
As an integral member of the Pharmacy Services, the responsibilities of the Pharmacy Technician Supervisor, include: managing the investigational product (IP) inventory; providing technical direction and assistance with clinical trial protocols; performing drug dispensing activities; maintaining information and record keeping related to clinical trials required by the study protocols; preparing IP products in accordance with protocols ; maintaining the clinical investigational work areas in a clean and orderly manner; performing training/educational functions; performing cross-functional and other duties and responsibilities consistent with the job classification.
Personnel
· Manages department to ensure operational objectives for project/trial are in conformance to all relevant laws, regulations, guidelines, project/trial protocols and internal SOPs/policies.
· Manages resources needed and assists in assigning individual responsibilities and project/trial assignment.
· Mentors and supports direct reports responsibilities and functions.
· Inspires and motivates employees to perform at their best through positive encouragement and incentive initiatives.
· Proactively assess staffing needs at assigned site(s) according to projections and productivity expectations and communicate needs to the senior management and Human Resources.
· Reviews and assists with initial interviews for all open direct report staff positions and provides feedback.
· Works with Human Resources to orient new employees using the new hire checklist process and complete building orientation.
· Works with Training and Development Lead to oversee the direct reports development of a customized training plan for each new hire according to their historic experience.
· Performs probationary and annual performance appraisals, setting annual goals and plans for each direct report with the support from the Training and Development Lead.
· Meets regularly with each direct report throughout the year to discuss progress on goals and provide timely feedback, including objective, measurable goals.
· Reviews personnel concerns with HR and thoroughly documents all personnel issues, as well as any coaching and counseling provided.
· Carries out disciplinary processes as required, providing thorough documentation to the HR team.
· DUTIES & ESSENTIALS JOB FUNCTIONS
o Manages the IP inventory.
o Manages inventory for clinical investigational drug trials, including independently ordering IP, within scope of authority, receiving, organizing, and monitoring the use of IP.
o Conducts physical counts of IP and resolves any discrepancies.
o Monitors expiry dates of IP and returns study materials, as required.
o Maintains separate supplies of returned IP from patients for trials that have this requirement.
· Provides technical assistance with clinical trial protocols.
o Utilizes knowledge of equipment and other technical skills to provide technical guidance for protocol summaries.
o Organizes a study binder for each trial with sections for all required documentation.
o Participates in the set-up of clinical drug trials, as required, including assembling study binders and other required items.
o Assists with staff orientation to clinical investigational drug trials.
· Maintains information and assists in the record keeping related to clinical trials required by the study protocols.
o Keeps updated on pharmacy manuals as required by the study protocol. Ensure Pharmacy Techs are adhering to study protocol guidelines.
o Files all paperwork pertaining to inventory control activities.
o Performs internal audits of IP dispensing records and helps resolve discrepancies.
o Meets with external monitors and responds to questions regarding inventory control and documentation and prepare responses in writing, if required.
o Prepares site-specific list of active drug studies on a regular basis for distribution to pharmacy staff, if required.
· Performs drug distribution activities.
o Preparing medication and supplies for dispensing.
o Ensures double-checking of all IP products before dispensing.
o Dispense medication to patients, as per protocol, for all clinical trials.
· Maintains the clinical investigational drug work areas in a clean and orderly manner.
o Ensures all IP trial work areas are maintained in a clean, orderly, organized and presentable manner.
o Ensures all active studies are maintained in an organized fashion to enable respective staff to clearly identify location of study binder and its respective drug supply.
· Performs workload measurement support functions.
o Assures completion of continuous quality improvement activities and workload reports.
o Submits required reports in a timely manner.
o Assists and participates in team and departmental planning.
· Performs quality improvement and quality assurance implementation.
o Perform regular internal audits on IP inventories and drug accountability logs.
o Assists in identifying problems and suggesting improvements.
o Assists in implementation of quality initiatives and improvements.
o Responds to technical inquiries from internal staff (i.e. pharmacy staff and study coordinators) and external personnel (i.e. monitors and auditors)
· Maintains proper functioning of equipment used.
o Logs temperatures of refrigerators and freezers on weekly basis.
o Ensures proper functioning of safety cabinets and thermometers.
· Maintains supervision of Pharmacy staff
o Ensures optimal coverage of Pharmacy staff at each site for all studies.
o Manages pharmacy schedule including out of office requests to ensure optimal coverage.
o Provides training and supervision to pharmacy staff including any updates on pharmacy manuals or new procedures.
o Ensures all direct reports adhere to the established Standard Operating Procedures (SOPs), Work Instructions (WIs) and meet timelines when performing pharmacy tasks.
o Performs evaluations and recommends next steps.
· Adheres to the established SOP and work instructions when performing pharmacy tasks and control review of project/trial related IP documentation.
· Knowledge of all awarded protocols and applicable supporting pharmacy manuals (as applicable).
· Ensure compliance with all study and non-study regulations, but not limited to the study protocol, HIPAA, OSHA, GCP, GDP, CRF and ICH Guidelines.
· Participate in projects/trials related meetings including but not limited to study award meetings, planning meetings, protocol training, and site initiation visits (as applicable).
· Works in compliance with the Occupational Health & Safety Act and its regulations, reporting hazards, deficiencies, and contraventions of the Act, in a timely manner.
· Performs cross-functional and/or other duties consistent with the job classification, as assigned or requested.
Work Location: In person
