Program Overview

Fundamentals of Clinical Research, an interactive program providing classroom training for the clinical research professional, begins with the history of legislation and regulations that govern clinical research and an overview of drug, biologic, and device development. Course participants develop a thorough knowledge base of Good Clinical Practices and International Conference of Harmonization guidelines (E6, E2A), gaining a solid understanding of clinical trial development and management.

Role Of CRA

A Clinical Research Associate, also known as a Monitor, is an individual that oversees the progress and conduct of a clinical trial. A clinical trial is usually implemented by physicians at a hospital, clinic, or physician's office. The CRA is required to oversee the initiation, progress, and conduct of the clinical trial to ensure the scientific integrity of the data collected, and the protection of the rights, safety, and well-being of human study subjects.

The CRA’s responsibilities include but are not limited to the following :

  • Monitoring that the physician adheres to Good Clinical Practices and the study protocol.
  • Performing study drug accountability;
  • Verifying the documentation of the informed consent process for each study subject;

Program Objectives

  • Upon completion of each course, participants will be able to:
  • Analyze and evaluate clinical data, to ensure investigator and site compliance with the study drug protocol, overall clinical objectives, FDA regulations, ICH Guidelines, Good Clinical Practice (GCP) and HIPAA.
  • Assure the protection of the rights, safety and well being of human study subjects.
  • Identify, help in the study site selection process, initiate, and eventually close out clinical study sites.
  • Monitor the progress of clinical study sites participating in a clinical study, and to assure the protocol is followed and data is reported accurately.
  • Make certain that the scientific integrity of the data collected is protected and verified.
  • Assure that adverse events are correctly documented and reported.
  • Review all case report forms and compare them to source documents.
  • Know the primary roles and responsibilities of the Clinical Research Associate (CRA), and Clinical Research Coordinator (CRC), or Clinical Data Manager (CDM).
  • Understand the drug development process and roles/opportunities in Clinical Research.
  • Identify ethical issues in clinical research and their impact on the development of new products.
  • Institute and obtain proper Informed Consent.
  • Understand the latest Good Clinical Practices.
  • Learn to employ efficient subject recruitment methods.
  • Develop a suitable clinical trial protocol and suitable study budget.
  • Identify adverse effects and proper reporting format.
  • Appreciate the types of sponsor-investigator site visits
  • Develop qualifications sought by the Pharmaceutical, Biotech & Medical Device industry

Career Outlook

The CRA is usually employed by a pharmaceutical company, contract research organization, academic institution, or site management organization. A CRA can work either in-house or in the field, requiring 50-70% travel. A field monitor will visit multiple sites and interacts with the study coordinator and the investigator conducting the trial. Pharmaceutical companies are presently seeking to reduce the development time necessary for their products to receive FDA approval for marketing. Monitoring of a clinical trial is the first mechanism in identifying potential data discrepancies and regulatory issues. A well-trained and knowledgeable CRA plays a vital role in protecting the study participant and helping to reduce the time between drug development and marketing approval. The demand for knowledgeable and trained CRAs continues to grow, however the supply is limited.