Pharmacist

Location: New Haven, CT

Duration: 1 year+

The Pharmacist provides operational pharmacy support, under the direction of the Head of Pharmacy, at a clinical development stage biopharmaceutical company. The Pharmacist will also support preparation of investigational doses for volunteers, meeting regulatory requirements for preparation of dose formulations under Good Clinical Practices (GCP) and in accordance with current pharmacy compounding best practices, including but not limited to, USP <797>, <795>, where applicable.

RESPONSIBILITIES: 

• Reviewing and/or executing extemporaneous dispensing records, dosage and administration Instructions, core protocol elements, protocol, informed consent documents, Clinical Supplies Request

• Drafting pharmacy budget for each study

• Completing daily setup work in support of dose preparation activities• Entering randomization data into electronic data capture management system

• Performing dummy run work to support verification of dose preparation

• Quality assurance role on dose preparations

• Pharmacy lead assignment on protocols

• Performing study closeout activities

• Maintaining accurate investigational drug inventories and supplies according to established policies and procedures

• Maintaining accurate control, accountability and distribution of controlled substances

• Dispensing investigational drugs to support clinical investigations

• Blinding of drug supplies

• Compounding and dispensing of oral, topical and parenteral dosage forms and matching placebo formulations

• Maintaining clinical supplies and compounding equipment

• Processing equipment/building repair requests