JOB SUMMARY: This position is responsible for preparing study medications as required by protocol under the supervision of a pharmacy Manager or licensed individuals.
ESSENTIAL FUNCTIONS: The Assistant Pharmacy Manager will execute all protocol requirements for investigational drugs and medications following good clinical practice (GCP), FDA regulations and requirements, sponsor expectations, and company standard operating procedures under the pharmacy manager's or licensed individual's supervision. The technician will be required to maintain accurate documents pertaining to the receiving, dispensing, returning, and/or destruction of all study medications.
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Receive investigational product (IP) shipments on site.
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Account for all shipment’s contents and their contents.
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Confirm in IWRS/IXRS shipment received or notify the sponsor that shipment was received if there is no IWRS/IXRS system.
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Document shipment and its contents on the IP logs.
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Print out monthly temp logs on the first business day of the month.
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Assessing temperature excursions as they occur, documenting the excursion, and completing any excursion paperwork, as well as notifying the sponsor of the excursion.
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IP dispensing and receiving from CRC’s.
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Double verification of IP dispensation and returns.
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Receives and directs visitors and clients.
EDUCATION AND EXPERIENCE:
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High school diploma or equivalent required.
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Bachelor’s degree in healthcare administration or a related field is strongly preferred.
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Must have 1+ years' experience working as a pharmacy technician.
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Clinical research experience is strongly preferred.
CERTIFICATIONS AND LICENSES:
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Registered Certified Pharmacy Technician required.
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Sterile compounding and IV certification required.
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Basic Life Support (BLS) certification required.
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Good Clinical Practice (GCP) Certificate.
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Valid driver’s license.
MINIMUM QUALIFICATIONS:
Strong computer skills, including proficiency in Microsoft Office
Excellent communication and customer service skills
Strong organizational skills and the ability to prioritize tasks
Strong attention to detail and ability to work independently
Ability to work in a fast-paced environment and handle multiple tasks simultaneously
KNOWLEDGE, SKILLS, AND ABILITIES:
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Written and oral communication skills.
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Organizational skills.
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Ability to pay attention to detail.
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People skills, including possessing a positive, friendly, and professional demeanor.
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Ability to be flexible with changing priorities.
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Ability to communicate in a diplomatic and professional manner.
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Strong interpersonal skills.
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Strong mathematical knowledge.
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Excellent computer skills.
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knowledge of Microsoft Office, Internet Explorer, Google Chrome, Mozilla Foxfire, and web-based enterprise solutions software.
SUPERVISION: None at this time
WORK ENVIRONMENT AND PHYSICAL DEMANDS
The work environment and physical demands described here are representative of those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.
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Work is performed in an office/laboratory and/or a clinical environment.
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Exposure to biological fluids and/or bloodborne pathogens.
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Personal protective equipment required, such as protective eyewear, garments, and gloves.
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Occasional travel may be required domestic and/or international.
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Ability to work upright and/or stationary for 6-10 hours per day.
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Frequent mobility required.
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Occasional squatting, kneeling or bending.
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Light to moderate lifting and carrying (or otherwise moving) objects, including medical equipment, with a maximum lift of 20-50 lbs.
About Pinnacle Clinical Research:
Pinnacle Clinical Research is dedicated to conducting cutting-edge research with a special focus on fatty liver disease (non-alcoholic). We pride ourselves on conducting high quality research as a complement to the medical care that our volunteers receive from their routine care center. Be a part of the discovery!