What is the role of a Clinical Research Pharmacist at Celerion?

The Clinical Research Pharmacist position at Celerion is a Full-time or part-time position opportunity in the Information Technology field.

Where is this Clinical Research Pharmacist job located?

Lincoln, Nebraska, 68502, United States

What type of employment is offered for this Clinical Research Pharmacist role?

Full-time or part-time position

What is the expected salary for this Clinical Research Pharmacist job?

Compensation will be discussed during the hiring process.

How can I apply for the Clinical Research Pharmacist position at Celerion?

You can apply directly through the application link provided.

Clinical Research Pharmacist at Celerion

Clinical Research Pharmacist

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.

Are you looking for an opportunity to support a business creating life-saving treatments? If so, we can't wait to meet you!

We have an exciting opportunity for an internal candidate to become a Clinical Research Pharmacist in our Lincoln clinic! In this role you will track, prepare, and account for all investigational products. You will act as a resource for study teams by utilizing pharmacological expertise and knowledge of pharmacy practice.

Essential Functions

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.

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
Full time positions - requires flexible work hours for early morning and occasional on-call weekend availability

This is a full time role in which you will work Monday–Friday, 8:30 AM – 5:00 PM. Early morning and weekend hours are required based on operational needs.

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.

Clinical Research Pharmacist at Celerion – Lincoln, Nebraska

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