Clinical Research Pharmacist

Celerion • Tempe, AZ

324d

About The Position

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. The Clinical Research Pharmacist will track, prepare, and account for all investigational products and act as a resource for study teams by utilizing pharmacological expertise and knowledge of pharmacy practice. Please note: Registered Pharmacist required.

Requirements

• Registered Pharmacist required.
• Doctor of Pharmacy preferred but not required.
• Proven pharmaceutical experience of minimum 1-2 years.
• Proven record keeping skills with extreme attention to detail.
• Knowledge of United States Pharmacopeia guidelines, including chapters 795, 797, 800, 1163, and 1168 as well as the FDA Guidance for Industry CGMP for Phase 1 Investigational Drugs required.
• Completion of media bi-annual media fill and fingertip testing (as applicable per site).
• Knowledge of FDA and EU regulations preferred (if appropriate).
• Job-specific training is required and will be provided.

Nice To Haves

• Knowledge of FDA and EU regulations preferred (if appropriate).

Responsibilities

• Responsible for receipt, storage, preparation, disposition, and retention of all study investigational products in compliance with standard operating procedures, FDA, and DEA regulations concerning investigational product handling, accountability and security.
• Review and understand study protocol requirements in regard to investigational product handling.
• Active member of study team providing expertise and support such as evaluating study feasibility, study set up and conduct, participating in internal and/or external client meetings.
• Provide internal and/or external client communication and interaction regarding investigational product handling and protocol specific requirements.
• Maintain aseptic compounding evaluation requirements.
• Provide training and monitoring for administration of investigational products as needed.
• Review and provide input to standard operating procedures and training plans pertaining to pharmacy and assisting with pharmacy training as necessary.
• Maintain pharmacy department equipment and applicable records as necessary.
• Institutional Review Board consultant and resource.
• Assist in training of new hires and students.

Benefits

• Flexible work hours, namely for occasional on-call weekend availability.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Ph.D. or professional degree