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Celerion · 1 day ago

Clinical Research Pharmacist

Tempe, AZ

Full-time

Onsite

Entry, Mid Level

1+ years exp

Celerion is committed to swift, exceptional clinical research through translational medicine. The Clinical Research Pharmacist will track, prepare, and account for all investigational products while acting as a resource for study teams utilizing pharmacological expertise and knowledge of pharmacy practice.

Health CarePharmaceutical

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

Knowledge of relevant 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

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

Work with the Pharmacist in Charge to ensure compliance with current USP guidelines and applicable Celerion SOP’s pertaining to extemporaneous pharmacy compounding if assigned the 'Designated Person' role

Review applicable compounding SOP’s every 12 months to ensure continued compliance with USP guidelines and implement changes, as appropriate

Ensure the CAPA system is initiated when warranted

Oversee pharmacy personnel compounding training program

Oversee compliance with USP guidelines

Oversee monitoring of the Designated Compounding Areas

Review and maintain all pharmacy compounding certification records (personnel and facility) to ensure completeness and compliance

Recognize problems, deviations, failures, and errors in the compounding process and the facility and report all issues to the Pharmacist in Charge

Qualification

Registered PharmacistUnited States Pharmacopeia knowledgePharmaceutical experienceFDA regulations knowledgeAseptic compoundingRecord keeping skills

Required

Registered Pharmacist required

Knowledge of relevant 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

Proven pharmaceutical experience of minimum 1-2 years

Proven record keeping skills with extreme attention to detail

Completion of media bi-annual media fill and fingertip testing (as applicable per site)

Job-specific training is required and will be provided

Requires flexible work hours, namely for occasional on-call weekend availability