Description:The Clinical Pharmacist works in conjunction with the Vice President and Principal Investigators to execute clinical trials in adherence to FDA/ICH and other state and local regulations following Good Clinical Practice standards while conducting clinical research trials. This position plays a pivotal role in our clinical research center, overseeing and managing all pharmaceutical aspects of our operations. This key leadership position requires a professional with an understanding of USP guidelines, and FDA requirements. The Clinical Pharmacist will be responsible for ensuring compliance, implementing best practices, and contributing to the advancement of pharmaceutical services within our organization.
Responsibilities:- Stay abreast of evolving USP guidelines, FDA requirements, and other relevant regulatory standards.
- Advise on drug development strategies, including formulation, stability, and regulatory submissions.
- Ongoing review, maintenance, and approval of established Standard Operating Procedures (SOPs) related to pharmaceutical services.
- Potential of implementing SOPs to meet GMP standards to allow for encapsulation, labeling, etc. in accordance with Sponsor direction and regulatory guidelines.
- Potential of preparing complex compounding drugs in a fully functional USP797 pharmacy
- Knowledge, understanding and execution of randomization used for each study, including being responsible for ensuring study specific randomization is followed when dispensing and transferring study medication for each IP administration for each study.
- Represent the pharmaceutical services department in cross-functional meetings and communicate effectively with stakeholders.
- Collaborate with external partners, including sponsors and regulatory agencies, to enhance the center's reputation and capabilities.
- Provide regular budget updates, forecasting future needs and identifying areas for optimization.
- Oversee relationships with pharmaceutical vendors, negotiating contracts, and ensuring compliance with service level agreements.
- Report any noncompliance issues to Vice President, Clinical Operations, and Investigators as soon as noticed.
- Executes clinical research trials in strict compliance with study protocol, standards of Good Clinical Practice, ICH guidelines, Standard operating procedures, QA/QC procedures, OSHA guidelines, Food and Drug Administration (FDA) guidelines, and other state and local regulations where applicable.
- Recruits, leads, and supervises the Pharmaceutical Services staff.
QUALIFICATIONS:- Clinical research experience preferred
- Sterile compounding and cleanroom experience preferred
- Knowledge of FDA/GCP/ICH guidelines preferred
- Certification / Licensure: State Registered Pharmacist
