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Research Pharmacist-FT
3 months ago
Job Location
LOC003 CPMI Clinical Pharmacology Miami - Hialeah, FL
Research Pharmacist
Title: Clinical Research Pharmacist-FT
Location: CPMI
Job Description:
We are looking for a Clinical Research Pharmacist to join our growing location. 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.
Responsibilities:
General
- 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.
- 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.
- Education and experience
- A PharmD or a bachelor's degree in pharmacy from an accredited school of pharmacy and one year of pharmacist experience.
- Current licensure as a pharmacist in the state of hire
- Prior hospital pharmacy experience strongly preferred.
- Understand regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.
- Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner.
- 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.
- Requirements
- 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)
About us:
ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with expertise in early and late-stage neuroscience drug development. With 20 wholly owned clinical sites and 4 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 400+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes, and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.
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