Research Pharmacy Tech Supervisor Segal Institute for Clinical Research - 4.0 Miami Lakes, FL Job Details Full-time 1 hour ago Qualifications HIPAA Filing Team development Interviewing Quality audits Full Job Description

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