Clinical Research Pharmacist

1 week ago

Torrance, California, United States The Lundquist Institute Full time

Position Overview

The Investigational Drug Services (IDS) Research Pharmacist is essential in the realm of clinical research, working closely with researchers to guarantee the safe and effective administration of investigational medications. This role involves a thorough review of clinical trial protocols to ensure compliance with regulatory standards and institutional policies, providing vital insights into study design, particularly in the areas of pharmacotherapeutics and pharmacokinetics.

Key Responsibilities:


• Development and Monitoring:
Engage in the formulation and ongoing evaluation of patient drug therapy plans and outcomes across various research initiatives.


• Patient Assessments:
Conduct comprehensive evaluations of patients and monitor the impacts of drug therapies utilizing clinical symptoms, laboratory results, and other relevant diagnostic methods.


• Compliance with SOPs:
Exhibit thorough knowledge and adherence to departmental Standard Operating Procedures (SOPs).


• Pharmacy Software Proficiency:
Demonstrate expertise in the pharmacy software system, PioneerRx, to facilitate efficient and precise operations.


• Subject Randomization Management:
Implement subject randomization through schemes and IWRS systems, gathering essential dose determination data and confirming eligibility and informed consent.


• Preparation of Study Medications:
Prepare oral and intravenous study medications using aseptic techniques for both adult and pediatric populations, ensuring adherence to high safety and accuracy standards.


• Record Maintenance:
Maintain accurate and up-to-date records and medication stock for all AIDS Clinical Trials Group (ACTG) studies, including mandatory monthly inventory audits.


• Inventory Verification:
Conduct monthly checks of physical inventory against perpetual accountability logs, maintaining temperature logs for refrigerators and freezers, and addressing any discrepancies.


• Medication Inventory Management:
Order study medications to sustain adequate inventory levels, conducting visual inspections at the time of dispensing and adhering to protocol-specific resupply requirements.


• Audit Preparation:
Compile internal documents and records in anticipation of audits, assisting auditors with document organization and preparation.


• Operational Efficiency:
Ensure the seamless operation of inventory and equipment, contributing to the overall functionality of the office.


• Department Information Updates:
Regularly refresh departmental information on the TU Intranet as needed, ensuring accuracy and relevance.


• Collaboration with External Entities:
Engage professionally with sponsors, CROs, and site personnel to ensure strict adherence to study protocols.


• Standard Operating Procedures Contribution:
Assist in the development and maintenance of departmental SOPs and processes, enhancing procedural accuracy and consistency.


• Meetings and Training Participation:
Attend and actively engage in staff meetings and training sessions, contributing to team development and expertise.


• Patient Confidentiality Maintenance:
Uphold a high standard of responsibility for maintaining patient confidentiality, ensuring the protection of sensitive information.


• Professionalism:
Maintain a courteous and tactful demeanor in all interactions with internal staff and external partners.


• Independent Operation:
Work with minimal supervision, demonstrating initiative in organizing and completing daily tasks efficiently.


• Proactive Problem Solving:
Utilize judgment based on company policies and departmental practices to independently resolve minor issues.


• Productivity Standards:
Consistently meet established productivity and task management benchmarks for assigned responsibilities, ensuring timely and accurate completion.


• Flexibility and Availability:
Be available outside of regular business hours for urgent study enrollments and randomizations, including weekends and holidays for investigational product preparation and dispensing.


• On-call Duties:
Participate in on-call rotations at least once a month, as required by active studies.


• Department Operations Support:
Take on additional responsibilities as necessary to ensure the efficient functioning of the department, demonstrating flexibility and commitment to team success.

Required Qualifications:

- A minimum of 5 years of extensive knowledge in both inpatient and outpatient pharmacy operations, showcasing a deep understanding of clinical practices in diverse healthcare environments.

- Doctor of Pharmacy (PharmD) degree from an accredited pharmacy school, ensuring a solid academic foundation and professional competence. Completion of at least one year of residency in a hospital pharmacy setting is preferred, emphasizing practical experience and advanced training in a clinical context.

- A valid pharmacist license in the State of California, maintained in good standing with the Board of Pharmacy, highlighting the professional and legal credentials necessary for the role.

In-depth Knowledge:

- Possess a comprehensive understanding of the operations of the Investigational Drug Service (IDS) and research pharmacy, including the complexities associated with various types of clinical trials.

Analytical Skills:

- Exhibit superior analytical abilities to assess problems and situations, making informed decisions and providing well-considered recommendations for resolution.

- Apply systematic analysis and common sense reasoning to identify and resolve issues, essential for effectively performing job responsibilities.

- Demonstrate a strong ability to function as a collaborative team member, fostering a supportive working environment.

- Excel in high-pressure situations, effectively managing multiple, sometimes conflicting deadlines while maintaining high performance standards.

- Interact with colleagues, clients, and stakeholders in a professional manner, upholding the highest standards of conduct.

Problem-Solving and Conflict Resolution:

- Exhibit cooperative behavior, showcasing positive problem-solving and conflict-resolution skills to navigate workplace challenges efficiently.

- Maintain availability for dependable and flexible work shifts, adapting to the dynamic needs of the department.

Salary Range: $65.00/hr.

*MON

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