Clinical Research Pharmacy Specialist (Center for Brain Health)

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.

• Comprehensive understanding of medicine, pharmacology, and current standard of care treatments.
• In-depth knowledge of Good Clinical Practice (GCP), investigational drug use/handling protocols, and FDA approval processes for new drugs.
• Proficiency in aseptic technique and non-sterile compounding, strongly emphasizing preventing contamination.
• Advanced knowledge of inventory management procedures and expertise in utilizing pharmacy information systems and electronic health records.
• Excellent attention to detail and maintaining accuracy while implementing effective quality control measures.
• Strong verbal, written, and interpersonal communication skills and ability to interact with diverse stakeholders in the clinical research process.
• Adaptability and resilience in managing uncertainty and rapid change, with strong problem-solving and decision-making skills.
• Provide reliable, responsive, safe, and courteous service to stakeholders while promoting an inclusive and collegial work environment.
• Understanding FDA health regulations and legal compliance requirements and providing accurate and timely medication education and counseling to patients and healthcare professionals.
• Expert knowledge of dosage administration, measurement techniques, chemical compounds, and pharmaceutical brands, including investigational and approved medications.
• Proficiency in data analysis and interpretation, with the ability to contribute to clinical trial design and protocol development.
• Strong project management skills, including the ability to coordinate multiple clinical trials while maintaining quality standards.