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Overview of Position

The lnvestigational Drug Services (IDS) Research Pharmacist (RP) plays a pivotal role in the clinical research landscape by collaborating with researchers to ensure the safe and effective use of investigational drugs. The RP rigorously reviews the clinical trial protocols to align with regulatory standards and institutional policies, providing critical input on study design, particularly in pharmacotherapeutics and pharmacokinetics. The responsibilities encompass overseeing the compounding, labeling, storage, and dispensing of investigational drugs, ensuring all preparations adhere to protocol specifications and maintaining meticulous documentation. Managing the inventory of investigational drugs, the RP ensures regulatory compliance and proper handling throughout the trial process, coordinating with clinical research teams to synchronize drug dispensation with study schedules and patient dosing requirements. The RP also monitors patient safety, educates healthcare providers and patients on proper drug use, and tracks patient outcomes for adverse reactions. The RP is well-versed in federal, state, and institutional regulations, preparing and managing documentation for compliance and audits, and ensuring adherence to Good Clinical Practice (GCP) guidelines. Additionally, they educate and train pharmacy staff, researchers, and clinical personnel, stay abreast of new developments in pharmacology, and actively participate in the creation of new protocols and scientific publications aimed at advancing pharmacotherapy outcomes and clinical pharmacology.

Primary Functions:

• Engages in Development and Monitoring:
• Actively participates in the creation and continuous monitoring of patient drug therapy treatment plans and outcomes across a variety of research programs.
• Conducts Comprehensive Patient Assessments:
• Performs thorough patient assessments and monitors the effects of drug therapy using clinical symptoms, laboratory data, and other pertinent diagnostic techniques.
• Ensures Compliance with SOPs:

Demonstrates in-depth knowledge and adherence to departmental Standard Operating Procedures (SOPs).

• Mastery of Pharmacy Software:
• Exhibits proficiency with the pharmacy software system, PioneerRx, to ensure efficient and accurate operations.
• Manages Subject Randomization:
• Executes subject randomization through schemes and IWRS systems, collecting vital dose determination data and verifying eligibility and informed consent with the caller.
• Prepares Study Medications:
• Prepares oral and intravenous study medications using aseptic techniques for both adult and pediatric patients, ensuring high standards of safety and accuracy.
• Maintains Accurate Records:
• Keeps precise and current records and medication stock for all AIDS Clinical Trials Group (ACTG) studies, including mandatory monthly inventory checks.
• Logs Transactions and Generates Labels:
• Records all transactions using various accountability logs and generates necessary pharmacy labels prior to dispensing study medications to participants.

• Performs Inventory Verification:
• Conducts monthly verification of physical inventory against perpetual accountability logs, maintaining refrigerator and freezer temperature logs, identifying, and rectifying any discrepancies.
• Manages Medication Inventory:
• Orders study medication to maintain adequate inventory levels, conducting visual inspections at dispensing time and following protocol-specific resupply requirements.
• Receives and Processes Shipments:
• Verifies the accuracy and condition of received shipments, entering details into accountability records, and reporting any discrepancies or damage promptly to relevant parties.
• Prepares for Audits:
• Assembles internal documents and records in preparation for audits, assisting auditors with document copying, packaging, and shipment preparation.
• Maintains Operational Efficiency:
• Ensures the smooth operation of inventory and equipment, contributing to seamless office functionality.

• Updates Department Information:
• Regularly updates departmental information on the TU Intranet as necessary, ensuring information is current and accurate.
• Collaborates with External Entities:

Interacts professionally with sponsors, CROs, and site personnel to ensure strict adherence to study protocols.

• Contributes to Standard Operating Procedures:
• Assists the director in the creation and maintenance of departmental SOPs and processes, enhancing procedural accuracy and consistency.
• Participates in Meetings and Trainings:
• Attends and actively participates in staff meetings and training sessions, contributing to team growth and expertise.
• Maintains Patient Confidentiality:
• Upholds a high degree of responsibility for maintaining patient confidentiality, ensuring sensitive information is protected.
• Exhibits Professionalism:
• Maintains a pleasant, courteous, and tactful demeanor in all interactions with internal staff and external vendors.
• Operates Independently:
• Works with minimal supervision, demonstrating initiative in organizing and completing daily tasks efficiently.
• Solves Problems Proactively:

• Uses judgment based on company policies and department practices to solve minor problems independently.
• Meets Productivity Standards:
• Consistently meets established productivity and task management standards for assigned duties, ensuring timely and accurate completion.
• Provides Flexibility and Availability:
• In case of necessity, available outside of regular business hours for time-sensitive study enrollments and randomizations, including weekends and holidays for investigational product preparation and dispensing.
• Performs On-call Duties (see attached document for expectations of on-call):
• Participates in on-call rotations at least one weekend or holiday per month, as required by active studies.
• Supports Department Operations:
• Takes on additional tasks as necessary to ensure the efficient operation of the department, demonstrating flexibility and dedication to team success.

Required Experience:

• 5 years of extensive and comprehensive knowledge of both in-patient and out-patient pharmacy operations, demonstrating a deep understanding of clinical practices in diverse healthcare settings.
• Doctor of Pharmacy (PharmD) degree obtained from an accredited school of pharmacy, ensuring a rigorous academic foundation and professional competence.
  Completion of at least one year of residency in a hospital pharmacy setting is preferred, highlighting practical experience and advanced training in a clinical environment.
• Must hold a valid pharmacist license in the State of California, maintained in good standing with the Board of Pharmacy, underscoring the professional and legal credentials essential for the role.

In-depth Knowledge:
• Possess a thorough understanding in the operations of the lnvestigational Drug Service (IDS)/ research pharmacy, including a thorough understanding of the complexities inherent in various types of clinical trials.

• Analytical Acumen:
• Demonstrates superior analytical abilities to scrutinize problems and situations, making informed decisions and providing wellconsidered recommendations for resolution.
• System Analysis and Problem Solving:
• Applies common sense reasoning and systematic analysis to identify and resolve issues, essential for performing the required job responsibilities effectively.
• Team Collaboration:
• Demonstrates a strong ability to function as an integral team member, fostering a collaborative and supportive working environment.
• Stress Management and Deadline Adherence:
• Excels in high-pressure situations, effectively managing multiple, sometimes conflicting deadlines while maintaining high performance standards.
• Professional Interaction:
• Interacts with colleagues, clients, and stakeholders in a professional and appropriate manner, upholding the highest standards of conduct.

• Problem-Solving and Conflict Resolution:
• Exhibits cooperative behavior, showcasing positive problem-solving and conflict-resolution skills to navigate workplace challenges efficiently.
• Flexible Work Availability:
• Maintains availability for dependable and flexible work shifts, adapting to the dynamic needs of the department.

Salary Range: $65.00/hr.

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