Job Description
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: The Pharmacist Assistant is responsible for ensuring accurate preparation, dispensing, and delivery of Study drug to the Research Area. This position will be assigned, as needed, by the Medical Director to designated CPMI staff (e.g., APRN, PA, RN, Clinical Research Coordinator, and/or Director of Clinical Operations). This position will have a variable work schedule, including flexible hours and weekends.
Responsibilities: Clinical: - Prepares dosing sheets, with protocol number, Study drug Identification, dosing route, dosing frequency, dosage amount, or any other identifier as required per Protocol
- Prepare labels for study drug with required identifiers as required per Protocol
- Prepare individual unit-dosing for each study subject as required per Protocol
- Knowledge of drug reactions and the synergistic effects of drugs combined with other medications
- Must be able to apply basic principles of mathematics to the calculation of problems associated with drug accountability and medication dosages
- Assist CPMI management with coordinating and scheduling Study drug dosing as required per protocol
- Assist Clinical Staff prepare participants for dosing
- Assist Clinical Staff set-up dosing area, dispense water, and supplies for dosing
- Keeps apprised of all new BLS/CPR and GCP/ICH rules, regulations and procedures
- Assist staff and related medical staff with study participants care as requested, to include but not limited to, lifting patients, cardiopulmonary resuscitation, bandaging and other life saving measures as directed
- Must be able to take pulse, blood pressure, visually observe changes in skin color
- Must be able to provide top quality care and concurrently handle high levels of stress
Administrative: - Maintains knowledge and understanding of SOP for data collection and study events
- Utilize standard procedures for the maintenance of positive subject identification and record appropriate collection information on proper study specific logs/flow-sheets
- Ensure accurate dispensing of Study drug as required per protocol
- Maintains accurate account of Study drug and neat documentation records as required per protocol
- Performs inventory of supplies needed and reports deficiencies to CPMI management
- Supply and stock Pharmacy with needed water, cups, dispensing vials, logs, etc.
- Follows proper safety procedures and reports any unusual incidents
- Knows OSHA and GCP/ICH rules and regulations and complies with all requirements
- Stays on duty/assigned shift until relieved by incoming staff
Educational: - Maintains current licensure, registration and/or certification within educational background
- Maintains necessary CEU's for licensure, registration and/or certification
- Actively participates on CPMI's ongoing Quality Assurance Program, HIPAA and Compliance Programs
- Keeps apprised of all new OSHA and GCP/ICH rules and regulations
- Attends all appropriate team meetings regarding study protocols
- Reads and understands CPMI policy and procedures manuals, SOP manual, and employee handbook
Additional Responsibilities: - Complies with all CPMI Policies and Procedures, especially those regarding protocol confidentiality
- Demonstrates a caring, professional attitude and behavior toward study participants and staff, actively contributing to the well-being and dignity of the clinic
- Maintains an overall good work attitude, promoting cooperation and professionalism and interactions with other staff members
- Maintains assigned work areas in a clean, safe condition, and reports any potential hazards immediately
- Performs all other duties as properly assigned
Skills and Qualifications: - Professional License, Registration and/or Certification in an Health Fields and at least one year of continuous experience in Clinical Research;
- ACLS or BLS/CPR valid certification preferred but not required;
- Requirements
- Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference of Harmonization (ICH) guidelines.
- Knowledgeable in medical terminology
- Excellent communication skills (interpersonal, written, verbal)
- 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)
- Bilingual skills are preferred but not required
Job Tags
Immediate start, Flexible hours, Shift work, Night shift,