Pharmacist; PRN

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PRN OCT-Ohio Clinical Trials, Columbus, OH, US

Salary Range: $80.00 To $90.00 Hourly

Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.

We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.

The Pharmacist prepares, compounds, manufactures, and dispenses investigational drugs and materials issued by the company for ongoing research studies. In executing these position responsibilities, the Research Pharmacist is guided by Good Clinical Practices (GCP), International Committee on Harmonization (IHP) guidelines, and company standard operating procedures and policies.

• Perform all study activities under the direction and delegation of the Principal Investigator
• Obtain detailed knowledge of all components of each study protocol through review and analysis of study information with Principal Investigator prior to the effective date of the study.
• Assist in establishing and maintaining a collaborative relationship with the Principal Investigator and the pharmacy.
• Meet with the investigators, study monitors, and others in coordinating study logistics.
• Receive copies of investigational brochures, study protocols, and pharmacy binders. Reviews documents and determines pharmaceutical materials and professional services required to satisfy the study description.

• Develop step-by-step procedures and/or kit for preparation, dispensing and distribution of investigational and study drug.
• Develop 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
• Responsible for the development of staff training regarding investigational and study drug procedures. Trains Research Pharmacy Technician, clinical research coordinators or any other appropriately delegated staff in the preparation of these agents, labeling appropriate record keeping and dispensing and kit utilization
• Prepare drug data sheets and other documents for Research Pharmacy Technician.
• Establish and maintain standards which assure the quality, proper storage and safe use of all investigational agents and related supplies.
• Delegate the ordering and stocking of investigational and study agents to the Research Pharmacy Technician(s). Ensure that this work is done according to protocol guidelines.
• Delegate the removal and disposal of expired stock or stock from completed or terminated studies to the Research Pharmacy Technician. Ensure that this work is done according to protocol guidelines.
• Ensure that 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.
• Responsible for and assist with the development of statistical reports and activity summaries as appropriate monthly. Such reports will be submitted to the Medical Director, Site Director, and Senior Clinical Research Coordinator for review.
• Responsible for and assist with appropriate monthly pharmacy audits to ensure that company policies and procedures are met. Assist in quality assurance procedures as needed.
• Maintain a neat and clean work area.
• Develop well organized work routine
• Additionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is…