Clinical Research Pharmacist

2 weeks ago


Tempe, Arizona, United States Celerion Full time
Clinical Research Pharmacist Job Description

Celerion is committed to delivering exceptional clinical research through translational medicine. As a Clinical Research Pharmacist, you will play a crucial role in helping us achieve this goal.

Key Responsibilities:
  • Track, prepare, and account for all investigational products in compliance with standard operating procedures, FDA, and DEA regulations.
  • Act as a resource for study teams by utilizing pharmacological expertise and knowledge of pharmacy practice.
  • Review and understand study protocol requirements in regard to investigational product handling.
  • Provide internal and/or external client communication and interaction regarding investigational product handling and protocol specific requirements.
  • Maintain aseptic compounding evaluation requirements and 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.
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).
Celerion Values:
  • Integrity
  • Trust
  • Teamwork
  • Respect

Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.



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