Overnight Pharmacist-Pharmacy

Evolution Research Group (ERG) is dedicated to delivering high-quality Phase IIV 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. 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 (ICH) guidelines, and company standard operating procedures and policies.
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.
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 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). Delegate the removal and disposal of expired stock or stock from completed or terminated studies to the Research Pharmacy Technician. 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.
This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG's objectives.
A PharmD or a bachelor's degree in pharmacy from an accredited school of pharmacy and one year of pharmacist experience.
Prior hospital pharmacy experience strongly preferred.
Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.
Knowledgeable in medical terminology to communicate with physician office and laboratory staff.
Demonstrate the initiative to act independently, initiate activity as required and make appropriate decisions within the constraints of study protocols, regulatory requirements, and company policy.
Able to initiate or modify behavior to achieve desired outcomes despite environmental factors, priorities, or problems that might not be well defined or that are subject to change.
Ability to perform overnight business travel
Basic computer skills to include Word, Excel, as well as proprietary applications unique to the clinical research industry (such as Study Manager)

Evolution Research Group