Foundations of Clinical Research

Description

Angela Kimel provides a brief overview of the clinical research industry and career opportunities in North Carolina including:

* What is a clinical trial and how is it regulated?
* Who are the key players?
* What is the drug development process?
* What type of careers exist in clinical research?
* What are the current educational opportunities in North Carolina?
* What does the clinical research arena look like in North Carolina?
* BioNetwork's role in preparing workers.

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Current Courses
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July
24
Introductory HACCP
Developing or following a Hazard Analysis Critical Control Point (HACCP) plan can be daunting. In this course, learn how HACCP systems work and your role in regulatory compliance. A series of interactive class exercises helps you nail down the step-by-step process of developing and implementing an
July
25
Introduction to Computer Validation
This course gives an overview of computer validation and its fundamental principles, for both automation and information systems. The course addresses the CGMP requirements related to computer validation, phases/life cycle of computer validation and computer systems, and documentation requirements
July
30
Aseptic Processing II
Build on the foundation you constructed in Aseptic Processing Level I with this course, a hands-on experience in which you hone aseptic operational skills in a simulated CGMP cleanroom environment. We supplement each laboratory activity with vibrant classroom discussion so what you learn isn’t just
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Current Courses
View All
July
24
Introductory HACCP
Developing or following a Hazard Analysis Critical Control Point (HACCP) plan can be daunting. In this course, learn how HACCP systems work and your role in regulatory compliance. A series of interactive class exercises helps you nail down the step-by-step process of developing and implementing an
July
25
Introduction to Computer Validation
This course gives an overview of computer validation and its fundamental principles, for both automation and information systems. The course addresses the CGMP requirements related to computer validation, phases/life cycle of computer validation and computer systems, and documentation requirements
July
30
Aseptic Processing II
Build on the foundation you constructed in Aseptic Processing Level I with this course, a hands-on experience in which you hone aseptic operational skills in a simulated CGMP cleanroom environment. We supplement each laboratory activity with vibrant classroom discussion so what you learn isn’t just
  •  
  • 1 of 5
  • >
eLearning
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Regulations and Guidance
Regulations and Guidance
In this eLearning module you will learn about the federal and international regulations that protect human participants in research studies. You will also get to be a drug company auditor, reviewing research studies at clinics to see if the staff are following the regulations, and looking for
Drug Development Overview
Drug Development Overview
This eLearning module will give you an understanding of the process used to develop drugs and why it costs so much to bring a new drug to your pharmacy.
Institutional Review Board (IRB)
Institutional Review Board (IRB)
This eLearning module will introduce you to the Belmont Report, levels of IRB review, and the use of consent waivers in clinical research studies.
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eLearning
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Microscope Basics
Microscope Basics
Take a self-guided exploration of a common laboratory microscope including its care, components, and usage. 
Drug Development Overview
Drug Development Overview
This eLearning module will give you an understanding of the process used to develop drugs and why it costs so much to bring a new drug to your pharmacy.
Good Laboratory Practices (GLP)
Good Laboratory Practices (GLP)
You’re the newest member of the Quality Assurance department at CATT - the Center for the Advancement of Toast Technology. Your mission is to audit the company and determine if it’s SOPs, notebooks, equipment, personnel, reagent labels, and test animals are GLP compliant.
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  • 1 of 4
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eLearning
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Good Laboratory Practices (GLP)
Good Laboratory Practices (GLP)
You’re the newest member of the Quality Assurance department at CATT - the Center for the Advancement of Toast Technology. Your mission is to audit the company and determine if it’s SOPs, notebooks, equipment, personnel, reagent labels, and test animals are GLP compliant.
Good Manufacturing Practice (GMP) Requirements
Good Manufacturing Practice (GMP) Requirements
GMPs help ensure the quality, safety, and efficacy of a product. You'll explore Good Manufacturing Practices as you work through several interactive scenarios in a virtual manufacturing facility.
Deliberate Documentation
Deliberate Documentation
Hi, I’m Mia! Let's discover how documentation is kept and used in a regulated manufacturing environment. So why is documentation important? Well, think about this situation. You’re preparing a solution that's used as a component in several products manufactured by your company. Many people count on
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Videos
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BioNetwork Capstone Center
Capstone Center
Capstone Center in Raleigh is BioNetwork's premiere worker training facility.  At Capstone, fundamental scientific understanding meets hands-on application.  Our industry-experienced instructors lead courses in bioprocessing, quality control, compliance, cGMP, analytical chemistry, and microbiology
Aseptic Gowning for the Cleanroom
Aseptic Gowning for the Cleanroom
One of the primary safeguards that life science companies use to help prevent contamination in cleanroom operations is Gowning. Gowning is basically putting on clothing -- in this case layers of specially designed garments, covers, masks and gloves -- that isolates your body from the clean room
Golden LEAF Biomanufacturing Training and Education Center
Golden LEAF BTEC: Knowledge in Action
The Golden LEAF Biomanufacturing Training and Education Center (BTEC) in Raleigh is home to two top-tier learning organizations: NC State and BioNetwork. Through this unique partnership, learners from a wide range of backgrounds can find the right educational program to meet their career goals, and
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  • 1 of 6
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Videos
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BioNetwork Capstone Center
Capstone Center
Capstone Center in Raleigh is BioNetwork's premiere worker training facility.  At Capstone, fundamental scientific understanding meets hands-on application.  Our industry-experienced instructors lead courses in bioprocessing, quality control, compliance, cGMP, analytical chemistry, and microbiology
Golden LEAF Biomanufacturing Training and Education Center
Golden LEAF BTEC: Knowledge in Action
The Golden LEAF Biomanufacturing Training and Education Center (BTEC) in Raleigh is home to two top-tier learning organizations: NC State and BioNetwork. Through this unique partnership, learners from a wide range of backgrounds can find the right educational program to meet their career goals, and
Bioprocessing Part 3: Purification
Bioprocessing Part 3: Purification
This video is the third in a series of three videos depicting the major stages of industrial-scale fermentation: fermentation, separation/recovery, and purification. This program describes the process by which a biological product—in this case, a pure, concentrated solution of Green Fluorescent
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Videos
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Lab Safety Lesson 1: Proper Dress and PPE
Lab Safety Lesson 1: Proper Dress and PPE
The lab environment is hazardous by nature. The actual risk is largely determined by you and those working with you. It's your responsibility to know and follow the rules and be able to recognize potential safety hazards. The first consideration is proper dress. What you wear in the lab can help
Aseptic Gowning for the Cleanroom
Aseptic Gowning for the Cleanroom
One of the primary safeguards that life science companies use to help prevent contamination in cleanroom operations is Gowning. Gowning is basically putting on clothing -- in this case layers of specially designed garments, covers, masks and gloves -- that isolates your body from the clean room
BioNetwork Capstone Center
Capstone Center
Capstone Center in Raleigh is BioNetwork's premiere worker training facility.  At Capstone, fundamental scientific understanding meets hands-on application.  Our industry-experienced instructors lead courses in bioprocessing, quality control, compliance, cGMP, analytical chemistry, and microbiology
  •  
  • 1 of 6
  • >
Activities
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Belly Busters
Belly Busters
Convert your students into a pharmaceutical research and development team! In this activity students use 21st century skills and science methodologies to develop a budget friendly antacid that provides patient relief without uncomfortable side effects. They'll learn how to not break the bank or
EASE (Effective Authentic Science Event)
EASE (Effective Authentic Science Event)
Would you like to host hundreds of prospective students on your college campus for a fun day of science and mystery?  EASE (Effective Authentic Science Event) is a one-day outreach program for middle school students with the goal of showing them that science is fun, and that the local community
GMO Detective
GMO Detective
How do scientists prove whether or not foods contain GMOs? Using real life techniques, students will perform several analyses to detect whether food samples have been genetically modified.
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  • 1 of 2
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Activities
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Belly Busters
Belly Busters
Convert your students into a pharmaceutical research and development team! In this activity students use 21st century skills and science methodologies to develop a budget friendly antacid that provides patient relief without uncomfortable side effects. They'll learn how to not break the bank or
EASE (Effective Authentic Science Event)
EASE (Effective Authentic Science Event)
Would you like to host hundreds of prospective students on your college campus for a fun day of science and mystery?  EASE (Effective Authentic Science Event) is a one-day outreach program for middle school students with the goal of showing them that science is fun, and that the local community
GMO Detective
GMO Detective
How do scientists prove whether or not foods contain GMOs? Using real life techniques, students will perform several analyses to detect whether food samples have been genetically modified.
  •  
  • 1 of 2
  • >
Activities
View All
GMO Detective
GMO Detective
How do scientists prove whether or not foods contain GMOs? Using real life techniques, students will perform several analyses to detect whether food samples have been genetically modified.
EASE (Effective Authentic Science Event)
EASE (Effective Authentic Science Event)
Would you like to host hundreds of prospective students on your college campus for a fun day of science and mystery?  EASE (Effective Authentic Science Event) is a one-day outreach program for middle school students with the goal of showing them that science is fun, and that the local community
A Royal Disease
A Royal Disease
Whenever an individual suffers an injury the body produces a fibrin polymer clot to stop the bleeding. Hemophilia, also known as "the Royal Disease," is a genetic disorder characterized by the low production of blood clotting factors necessary for the formation of the fibrin clots. In this activity
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