Clinical Pharmacist – Research Trials & GMP Lead

Qps-Holdings,-LL; Springfield (MO); On-site; USD 120,000 - 150,000; Full time

Job summary

QPS is seeking a Clinical Pharmacist in Springfield, MO to oversee and manage all pharmaceutical aspects of our clinical research center. You will ensure regulatory compliance, SOP adherence, and collaboration with sponsors and investigators to advance pharmaceutical services.

The role requires knowledge of USP guidelines, FDA requirements, and GMP considerations, with leadership responsibilities including staff supervision and cross-functional coordination.

Qualifications

• Clinical research experience preferred.
• Sterile compounding and cleanroom experience preferred.
• Knowledge of FDA/GCP/ICH guidelines preferred.
• Certification / Licensure: State Registered Pharmacist.

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 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 ensuring study-specific randomization is followed when dispensing and transferring study medication for each IP administration.
• 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, FDA guidelines, and other state and local regulations where applicable.
• Recruits, leads, and supervises the Pharmaceutical Services staff.

Skills

Clinical research experience

Sterile compounding

FDA/GCP/ICH guidelines

Education

State Registered Pharmacist

Job description

QPS is seeking a Clinical Pharmacist in Springfield, MO to oversee and manage all pharmaceutical aspects of our clinical research center. You will ensure regulatory compliance, SOP adherence, and collaboration with sponsors and investigators to advance pharmaceutical services.

The role requires knowledge of USP guidelines, FDA requirements, and GMP considerations, with leadership responsibilities including staff supervision and cross-functional coordination.