10-Week Fundamentals of Clinical Research Series: Getting Started in Clinical Research

Course Description

The 10-Week Fundamentals of Clinical Research Series provides a comprehensive introduction to clinical research for those who are new to or interested in working on pharmaceutical and medical device clinical trials. Participants will learn about the basics of clinical research, including industry practices and rationale, and how key concepts apply directly toward clinical research efforts, which are often mandated by regulations and guidelines. The series covers core sponsor and investigator site activities to help learners understand the key considerations in the real-life work of clinical researchers.

The resources required to take this on-line course are already at your fingertips - an Internet connection and a phone. After registering, you will receive an email confirmation that provides you with the Web Seminar link and audio connection information.

Prior to the start of the course, participants will receive comprehensive course materials. Come to class prepared to interact – you will be able to ask questions, provide feedback and participate in discussions and group work. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

Learning Objectives

  • Define clinical research and discuss how preclinical development leads to clinical development
  • Explain the roles and responsibilities of all members of the clinical team: Sponsor, vendor, CRO, investigator, Institutional Review Board, subject and regulatory authority
  • Describe the investigational product development process including study design and the logic involved
  • Define the regulatory requirements, including principles of Good Clinical Practice from the International Council for Harmonization, FDA regulations
  • (Code of Federal Regulations), ethical considerations for a study and the need for Standard Operating Procedures
  • Define the steps involved in proceeding with the study: Sponsor development of protocol, case report form, informed consent document, budget, database and identifying an investigational site
  • Describe the conduct of the study including monitor visits to the site and site performance management and communication
  • Describe the management of adverse events and completion of study reporting and retention of documents
  • Identify career opportunities and reference materials available

Who Should Attend

  • Those who are new to clinical research
  • Aspiring Clinical Research Coordinators and Clinical Research Associates
  • Nurses interested in clinical research
  • Aspiring and Entry Level Project Managers (looking to gain experience in clinical research)
  • College Students and New Graduates in a Scientific Field

NOTE: This course is for individual registrants only and does not allow for group training.