Clinical Research Pharmacy RN-PRN

Job Description

Job Description

About Us:

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 RN will prepare and dispense investigational drugs and materials issued by the company for ongoing research studies. In executing these position responsibilities, the Research RN is guided by Good Clinical Practices (GCP), International Committee on Harmonization (IHP) guidelines, and company standard operating procedures and policies. This role is approximately 25 hours per week, with the possibility of additional hours. We are flexible regarding the days of the week.

Pharmacy Activities

• 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.
• Prepare 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 intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.

Skills and Qualifications:

• Education and experience
  • Graduate / completion of approved accredited school of nursing. Education and requirements will be determined by the site need and protocol requirements.
  • Valid License as an RN in the state of practice; maintain current license.
  • Must have a minimum of one (1) year of clinical research experience.
  • CPR Certification required, ACLS preferred for RN.
  • Phlebotomy certification (national) preferred.
  • Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Communicate with providers, co-workers, and others in a collaborative and courteous manner.
  • Knowledgeable in medical terminology to communicate with physician office and staff.
  • 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.
• Requirements
  • Ability to work independently and as a team player.
  • Ability to organize and prioritize within a changing environment.
  • Uses safety/universal precautions to protect self, subjects and staff.
  • Able to appropriately implement protocol and regulatory requirements in study conduct.
  • Proficient in venipuncture, centrifugation, sample storage and performing electrocardiogram.
  • Excellent documentation practices
  • Good organizational and interpersonal skills
  • Attentive to detail, good initiative and able to work with changing priorities.