Celerion is a clinical research company that uses innovative research strategies to help get drugs to market faster. The Clinical Research Pharmacist in Charge will be responsible for managing pharmacy operations, staff, and study teams.
Requirements
- Track, prepare, and account for all investigational products
- Act as a resource for study teams by utilizing pharmacological expertise and knowledge of pharmacy practice
- Manage pharmacy schedule and assignment of studies
- Ensure compounding suites are maintained and certified on an ongoing basis
- Manage receipt, storage, preparation, disposition, and retention of all study drug products
- Review and understand study protocol requirements in regard to investigational product handling
- Prepare study specific pharmacy manuals for any type of compounding studies
- Ensure EU, Controlled Drug, and DEA license (if applicable) is current and all federal and state laws pertaining to prescription medications are being followed
- Interact with all applicable regulatory agencies, as necessary, regarding investigational product and investigational product supply handling
- Track and maintain appropriate pharmacy metrics as necessary, including retention follow up/invoicing
- Track and manage pharmacy expenses including supplies, fees, contractors, and payroll
- Provide training and monitoring for administration of investigational products as needed
- Develop and review standard operating procedures and procedure guides pertaining to pharmacy and including pharmacy training as necessary
- Maintain pharmacy department equipment and applicable records as necessary in conjunction with the lead pharmacy technician
- Document and report any and all pharmacy deviations and implement process improvement changes as applicable
- Assist with special projects as needed
- Active member in the clinic leadership team and attending management meetings as necessary
