Foundations of Clinical Research

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.

​

Related Content

Current Courses
View All
September
30
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
November
7
Fundamentals of Validation
This course is designed to introduce technicians and professionals to the principles and regulatory requirements of current drug, biologic and medical product validation. A brief historical overview of regulatory requirements is followed by current requirements, user needs, process design and
November
18
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 2
  • >
Current Courses
View All
June
18
Starting Your Herbal Products Business
Do you have an amazing herbal product you’d like to share with the world? Then this is the webinar for you! Learn the nuts and bolts of setting up a business keeping in mind specific considerations related to herb product manufacturing, marketing and sales. Whether you are planning to make products
June
24
Biomanufacturing Bootcamp
This course allows participants to experience biopharmaceutical manufacturing through lectures and hands-on production of green fluorescent protein (GFP) within a current good manufacturing practices (cGMP) environment. The course details the steps and equipment utilized in the upstream and
July
25
Good Documentation Practices and Data Integrity
Are you responsible for preserving documents or for ensuring that your company’s data is complete and correct? Stay on top of your field by learning the regulatory requirements and best practices for pharmaceutical documents, documentation, and record keeping. In this course, we review the
  •  
  • 1 of 2
  • >
eLearning
View All
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.
  •  
  • 1 of 5
  • >
eLearning
View All
cGMP OSHA
cGMP OSHA
Lesson 3: In this guided exercise, learners will explore environmental protection policies, look at the purpose of and use of Material Safety Data Sheets (MSDS/SDS), and explore how to protect yourself from injury on the job.
cGMP Bloodborne Pathogens
cGMP Bloodborne Pathogens
Lesson 2: Bloodborne Pathogeons explores the fundamentals, transmission methods, and prevention techniques for reducing the risk of exposure. This lesson also details several common types of bloodborne pathogens as well as reviews personal protective equipment, proper response to exposure, and
cGMP Basics
cGMP Basics
Lesson 1: Introduction to Current Good Manufacturing Practices, introduces the fundamentals of cGMP and how they apply to the companies that implement them, the employees that use them, and the customers that benefit from them. At the completion of this training exercise, the learner will be able
  •  
  • 1 of 5
  • >
eLearning
View All
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
  •  
  • 1 of 5
  • >
Videos
View All
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
  •  
  • 1 of 6
  • >
Videos
View All
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
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
  •  
  • 1 of 6
  • >
Videos
View All
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
View All
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
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
  •  
  • 1 of 2
  • >