About Company
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.
Why join us? 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.
Job Description
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
- Follow step-by-step procedures and/or kits for preparation, dispensing and distribution of investigational and study drug.
- Use 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
- Use drug data sheets and other documents
- Maintain standards which assure quality, proper storage and safe use of all investigational agents and related supplies.
- Perform ordering and stocking of investigational and study agents.
- Perform the removal and disposal of expired stock or stock from completed or terminated studies according to protocol guidelines.
- Complete and retain paperwork.
- Handle investigational and study drugs according to the requirements of the sponsoring agencies.
- Prepare special formulations of investigational agents under unusual circumstances as dictated by a particular protocol.
- 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 a 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 intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.
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
