Clinical Research Pharmacist

Aqualane Clinical Research

Clinical Research Pharmacist3200 Bailey Lane, Naples, Florida, 34105

Full Time
  • Clinical Research Pharmacist_0

About Clinical Research Pharmacist

The Clinical Research Pharmacist plays a pivotal role in the planning, implementation, and oversight of pharmaceutical aspects within clinical research studies. This position involves ensuring the safe and effective use of investigational drugs, managing drug-related protocols, and providing expertise in pharmaceutical care to support the conduct of clinical trials.

 

Responsibilities:

  1. Investigational Drug Management:
    • Oversee the procurement, storage, dispensing, and accountability of investigational drugs (INDs) and study medications in accordance with study protocols and regulatory requirements.
    • Develop and maintain drug accountability procedures, including documentation of drug shipments, dispensing records, and inventory management systems.
    • Ensure compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and other relevant regulatory standards for investigational drug handling.
  2. Protocol Development and Review:
    • Provide pharmaceutical expertise in the development and review of study protocols, including drug dosing regimens, drug interactions, and safety monitoring procedures.
    • Collaborate with investigators, study sponsors, and regulatory authorities to ensure that drug-related protocols are scientifically sound, ethically appropriate, and compliant with regulatory requirements.
  3. Participant Safety and Monitoring:
    • Monitor participant safety throughout the duration of clinical trials, including adverse event monitoring, pharmacovigilance activities, and drug safety reporting requirements.
    • Provide drug information and counseling to study participants, healthcare providers, and study team members regarding investigational drugs, including indications, contraindications, and potential adverse effects.
  4. Regulatory Compliance:
    • Ensure compliance with regulatory requirements and guidelines governing the conduct of clinical research, including Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and applicable local regulations.
    • Assist in the preparation and submission of regulatory documents related to investigational drugs, such as investigational new drug (IND) applications, pharmacy manuals, and drug accountability logs.
  5. Collaboration and Communication:
    • Collaborate with multidisciplinary teams, including clinical research coordinators, principal investigators, and regulatory affairs professionals, to ensure effective coordination of pharmaceutical aspects within clinical research studies.
    • Communicate with study sponsors, contract research organizations (CROs), and regulatory agencies regarding drug-related issues, study progress, and regulatory submissions as needed.

Qualifications:

  • Previous experience (typically 2-5 years) in clinical pharmacy practice, pharmaceutical research, or drug development within the pharmaceutical industry or academia.
  • Strong understanding of pharmacokinetics, pharmacodynamics, and drug metabolism principles as they relate to clinical research.
  • Excellent communication, interpersonal, and problem-solving skills.
  • Proficiency in using pharmacy information systems, electronic data capture systems, and Microsoft Office applications.

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