Clinical Research Course

The Clinical trials industry is a fast growing multi-billion dollar industry that is making a significant impact in the improvement of healthcare delivery across the globe. The clinical trials industry is expected to be worth $65 billion by the year 2025.

To effectively conduct clinical trials, sponsor companies (pharmaceutical and medical device) as well as contract research organizations (CROs) depend on the expertise of clinical research associates (CRA) and clinical research coordinators (CRC). Considering the expansion rate of this industry, there is a need for the influx of more CRAs and CRCs into this field.

The course we are offering is a clinical research training course to prepare professionals for clinical trial jobs in the pharmaceutical and medical device industries.

Do any of the below apply to you?

  • You’ve gone through four years of college education and have a degree engineering, science or management
  • You’ve spent years working as a foreign doctor or even had your own private practice as a clinician
  • You’ve successfully completed a certification in clinical trial management

Then you have the background and skills needed to become a CRC and earn a median salary of $62,000/year.

Why become a clinical research professional (CRC)?

CRCs are part of the key players involved in clinical trials all over the world. Clinical trials serve as a very important clinical and regulatory step in bringing new safe and effective drugs into the market as well as innovative medical devices that will help tackle a lot of the medical conditions faced by lots of patients all over the world.

We offer both individual and group training courses for those interested in becoming clincial research associates. IMGC also provides professional support for CRCs already in the industry. Our Instructors are medical professionals (MDs, RNs, etc.) who are experienced clinical research professionals.

What else?

In addition to the ability to read, interpret, and understand medical technology, clinical research associates must have excellent interpersonal and communication skills. The ability to understand best clinical practices, design protocols, and data standards requires CRCs to have outstanding attention to detail, analytical skills, and the capacity to deliver constructive feedback to participating research sites on their performance. Although not a requirement, many CRCs travel between multiple research sites for study oversight, which may require a valid driver’s license, the physical capacity to travel, and/or willingness to fly or drive on a regular basis.

We offer both individual and group training courses for those interested in becoming clincial research associates. IMGC also provides professional support for CRCs already in the industry. Our Instructors are medical professionals (MDs, RNs, etc.) who are experienced clinical research professionals.

Dr. Kiki Diorgu

Dr. Kiki Diorgu is a medical research professional with experience in both U.S and international clinical trials, regulatory affairs services and medical education. Dr. Diorgu currently serves as the Director of Clinical Operations foran industry leading clinical research organization , that manages several multicenter and international clinical trials in the pharmaceutical and medical device industries. Dr. Diorgu has pioneered several initiatives in the education sector and has prepared several medical students for the U.S medical board exams. He is a Clinical Instructor with IMGC Prep and an adjunct teaching faculty with the American University of Integrative Sciences, School of Medicine. In 2011 he founded Kikiprep, an agency providing educational services for medical students and medical graduates preparing to sit for the U.S medical boards (USMLE) as well as high school and college students preparing for tests such as the SAT, ACT and MCAT.

 

Clinical Research training
Information session and open house: August 31, 2019
Course dates: Coming soon

IMGC offers the CRC training course in a variety of formats. Online individual & group courses are available as well as courses at the IMGC clinical training facility in Tucker, GA.

Becoming a CRC allows you the opportunity to make meaningful contributions to the healthcare industry, without a nursing or doctoral degree.

Questions about the CRC or any other IMGC courses can be directed to our contact page; or by clicking the following button. 

CRC Course Topics

Introduction to Clinical Research

History of Clinical research, Key players in a clinical Trial, Governing authorities (FDA, IRBs), Purpose of clinical trials, Types of clinical trials, Therapeutic areas in clinical research, Phases of clinical trials, Differences in clinical trial design.

Central Trial Documents

Introduction to the Clinical Trial Protocol/ Investigative Plan, Key elements of the trial protocol, Amendments to the clinical trial protocol, Investigator brochure (IB), Required elements of the informed consent

Adverse Events (AE)

AE definition, AE documentation, Serious Adverse Events (SAEs), SAE reporting, Unanticipated Adverse Events, MedRA coding and CTCAE

Investigational Product (IP)

Types of IP, IP shipment, IP documentation and accountability, IP storage requirements

Site Set-Up and Initiation

Site initiation visit (SIV), SIV follow up, Essential documents collection

Site Close-Out

Site close out activities, Site close out visit, Maintenance and retention of records

Regulations & Guidelines

ICH GCP E6 Good Clinical Practice, Code of Federal Regulations Title 21, Applicable ISO guidelines, FDA guidance documents, HIPAA, Standard operating procedures (SOPs)

Site Management

Site communications, Enrollment and Recruitment, Maintenance of study documents, Site monitoring overview

Career Mentoring

Industry overview, Interview tips and frequently asked questions, Mock interviews 

Data Monitoring

Source data, Source documents, Source data verification, Remote vs onsite monitoring, Queries, Edit checks

Data Monitoring Committees

Data Safety Monitoring Board (DSMB) overview, DSMB charter and member requirements, Clinical Events Committee (CEC), CEC charter and member requirements, Medical Monitor

Relevant Study Management Documents

Clinical Monitoring Plan (CMP), Safety Management Plan (SMP), Data Management Plan (DMP), Medical Monitoring Plan (MMP), Communication Plan (CP)

Clinical Research Vocabulary

Clinical research acronyms and abbreviations, Medical terminology, Common concomitant medications, Common medical history diagnostic terms

Pre-Trial Activities

Site identification, Site feasibility, Site qualification, Budgeting and Finance, Agreements/Contracts

Investigative Site File (ISF)

Introduction to the ISF binder, Required contents of the ISF binder, Ongoing maintenance of the ISF binder, ISF binder storage

Data Management Systems

Electronic Data Capture (EDC), Electronic Trial Master File (eTMF), Clinical Trial Management Systems (CTMS), Regulatory requirement for data management systems

Protocol Deviations/Violations

Protocol deviation vs violation definitions, Protocol deviations/violations reporting, Planned deviations from the protocol

Good Documentation Practices

Overview of ALCOA, Document signature requirements, Document control and versioning, Training documentation