Title: Pharmacy Technician

Location: Endeavor Clinical Trials

Job Description:

ERG is the largest independent clinical research site services company focused on special populations and is the market leader in CNS. With 20 wholly owned clinical sites, we conduct in-patient and out-patient phase I-IV clinical research studies. Our mission is to provide the highest quality execution of clinical trials in all clinical research phases aimed at helping sponsor companies to get their life saving or life enhancing drugs to market as quickly and safely as possible.

This role prepares, compounds, manufactures, and dispenses investigational drugs and materials issued by the company for ongoing research studies. The candidate will be responsible for the coordination, organization, and efficient implementation of clinical data as it relates to the conduct of site’s IP Pharmacy, and completes all duties under the direction of the Site Manager or designee. In this role you will maintain accurate, confidential files and documentation of study participants. In executing these position responsibilities, the Research Pharmacist is guided by Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA) and company standard operating procedures and policies.

We value the spirit of collaboration in our teams and believe that to be successful, we must be a patient centric organization. The successful candidate will be certified as a Pharmacy Technician or be an LPN with clinical research pharmacy experience. Must be knowledgeable in medical terminology and be well organized and methodical in approach.

Responsibilities:

• Follows step-by-step procedures and/or kit for preparation, dispensing and distribution of investigational and study drug.
• Uses codes, labels and other predefined formats for pharmacy computer entry.
• Establish and maintain adequate and easily retrievable recordkeeping systems for protocols, study subjects, drug inventory and dispensing investigational drugs per regulatory requirements and ICH guidance requirements for handling investigational products
• Uses drug data sheets and other documents
• Maintains standards which assure the quality, proper storage and safe use of all investigational agents and related supplies.
• Performs ordering and stocking of investigational and study agents.
• Performs the removal and disposal of expired stock or stock from completed or terminated studies according to protocol guidelines.
• Paperwork is completed and retained, and that investigational and study drugs are handled according to the requirements of the sponsoring agencies.
• Prepares special formulations of investigational agents under unusual circumstances as dictated by a particular protocol.
• Assists with appropriate monthly pharmacy audits to ensure that company policies and procedures are met. Assist in quality assurance procedures as needed.
• Maintains a neat and clean work area.
• Develops well organized work routine

Skills and Qualifications:

• Education and experience
  • Training and/ or certification as a Pharmacy Technician
  • Prior hospital pharmacy experience is strongly preferred
  • Knowledgeable in medical terminology
• Requirements
  • Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods.
  • Excellent verbal and written communication skills