The CRA Institute

Training Goals

1. To provide a thorough review of the good clinical practices (GCP), ICH, FDA/TPD regulations, roles, and responsibilities of the Clinical Research Associate/Monitor and Coordinator.

2. To provide you with the key skills, job criteria and industry expectations for the positions of Clinical Research Associate/Monitor and the Clinical Research Coordinator.

  Hands on Experience

You will be allowed to participate in many simulations during the training program that give you  "hands on experience" in actual monitoring situations such as Investigator Selection, IRB Approval, CRF Review, SDV, Good Clinical Practice and Drug Accountability and Adverse Event assessment.

Training Objectives

Upon completion of this program, 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).

· 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.

Target Groups

· Nurses, Clinical Research Coordinators, Clinical Research Associates.

· Physicians, Dentists, Physician Assistants, Medical Monitors, Statisticians, Biostatisticians

· Pharmacists, Pharmacologists

· Medical Technologists, Laboratory Technicians

· Physical Therapists, Respiratory Therapists, Psychologists

· Biologists, Chemists, Medical Writers.

Training Duration

·         Average completion time - 2 to 3 months studying part-time

·         Actual completion time varies depending on your pace of study

Training Costs

·         Tuition fee - $1,495.00 (US funds)

·         Registration fee - $155.00 (US funds)