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Title: Pharmacist
Time Period:12 Months
Location: New Haven, CT

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 , , where applicable

Primary Duties:
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.

Qualifications needed are PharmD degree, CT State licensed pharmacist, at least 3 years of pharmacy practice experience in a setting preparing both sterile and non-sterile dosage forms, and completion of an accredited post-PharmD residency and/or fellowship. Math required.; Expertise in IV admixture per USP required.
The successful candidate is expected to be competent in investigational drug management including protocol support activities; product development and formulation; investigational drug information development; and, control, storage, use, handling and accountability of investigational agents including controlled substances. Must be detail-oriented and possess strong organizational skills and the ability to prioritize multiple tasks/projects. Teamwork skills are essential.

Notes: All candidates must be CPR certified for this location. DEA screening must be run on awarded candidate. Licensed pharmacist with state of CT
must be medically cleared to wear a respirator and fit test
manager is looking for a pharmacist not a technician
candidates must have 5 years of experience in a pharmacy setting

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