The Clinical Research Pharmacist Specialist specializing in investigational drug services (IDS) is multifaceted, combining expertise in clinical pharmacy with the unique demands of managing investigational products in clinical trials. Will serve as a critical link between various stakeholders in the clinical research trial’s operations and process. Coordinate and execute all aspects of investigational drug handling. Maintain accurate inventory records and drug accountability documentation. Oversee the use of investigational drugs according to IRB-approved protocols and contribute to safety monitoring efforts, including adverse event reporting. Assist in streamlining the complex process of drug development, from initial trials to potential market approval. Ensure adherence to federal and state regulations governing investigational new drugs (INDs) and compliance with Good Clinical Practice (GCP) guidelines and FDA regulations, in a hospital and clinical setting.

• Serves as a key liaison between clinical trial operation teams, healthcare providers, protocol sponsors, pharmacy operations, and the EPIC team, ensuring seamless communication and coordination. 
• Leads and actively participates in investigational drug service initiatives, including education, clinical research, performance improvement, drug accountability, study audits, and professional development. 
• Assess individual protocols for coherence, soundness, feasibility, and practicality, contributing to research protocol reviews and evaluations.
• Develop comprehensive procedural materials, order sets, and resources for investigational product preparation and dispensation within the pharmacy. 
• Provides timely medication information and education to staff and patients regarding investigational drug services, including potential side effects and drug interactions. 
• Participates in clinical trial office committees and initiatives to develop, improve, and implement new strategies and tools for enhancing investigational workflow. 
• Oversees the preparation, packaging, and distribution of investigational treatments, ensuring compliance with protocol requirements and safety standards. 
• Maintains accurate and detailed records on patient prescriptions, charges, inventory, and drug returns, adhering to regulatory requirements and institutional policies.
• Supervises and guides pharmacy technicians.
• Analyzes, compares, and evaluates various courses of action, making independent decisions to optimize clinical trial processes and outcomes. 
• Conduct regular audits and quality checks to ensure compliance with Good Clinical Practice (GCP) guidelines, FDA regulations, and institutional policies.  
• Collaborates with research teams to design and implement pharmacokinetic and pharmacodynamic studies within clinical trials. 
• Performs all other duties as assigned, maintaining flexibility to adapt to the evolving needs of the hospital and clinical research environment.

Education: Bachelor's Degree Pharmacy is required Master's Degree Doctor of Pharma cy from an ACPE accredited college of Pharmacy is preferred. 

Experience: Two (2) years of pharmacy experience in a hospital pharmacy setting or a setting directly related to area of specialty.

License/Certification: BLS Basic Life Support due within 7 days of hire date. BCPS Board Certified Pharmacotherapty Specialist is preferred.