My client is expanding globally and seeks a trained phase 1 clinical trial Pharmacist to grow and lead a group. This person will take on the following tasks:
· Review and edit phase 1 protocols and contribute to protocol development. Ensure global compliance with GCP principles and documentation standards.
· Create pharmacy manual development, design, and review, including tools to communicate the scope and the value of service to sponsors.
· Develop and implement systems and IT tools. Create standardized forms and templates for source documents, including study-specific physician order forms, drug preparation instructions, and other forms needed for phase 1 investigational studies.
· Develop employee job descriptions, training, and on-boarding program, competency checklists, performance standards, and performance evaluations.
· Develop and define quality metrics and system for routine reporting to ensure that all departments are fully compliant with SOPs.
· Confirm compliance with all applicable Federal, State, and local laws and regulations and internal quality standards as they apply to investigational drug dispensing.
The ideal candidate will possess the following qualities:
· Pharmacy license in good standing and 5+ years hospital or clinic pharmacy experience.
· Sterile compounding & chemotherapy certification required.
· Prior experience in clinical trials and management of investigational drugs, including knowledge of dosage requirements and precautions for oncology patients.
· Familiarity with sterile compounding requirements for chemotherapy agents.