Clinical Careers

Training for Quintiles CRAs

At Quintiles Academy, latest and advanced practical trainings are provided to nearly 1,000 Clinical Research Associates (CRAs) and Medical Representatives (MRs) every year. The training content is based on our wealth of experience as one of the leading companies in the industry. This extensive know-how is obtained from various operations Quintiles has been entrusted with as CRO over the years, and information gained through Quintiles’ global network of talented professionals. Information is updated every day. Our training programs aim to be the industry standard with distinguished trainers and latest training curriculum.

Introduction Training

At Quintiles, education and training standard is set for candidate CRAs and the Introduction Training (first term: around 1 month) is provided for candidate CRAs to acquire basic knowledge under “Good Clinical Practice” (GCP, 1 Oct 2008). After the training (first term), the candidate CRAs learn more day-to-day operations with detailed practical monitoring, role-playing and helping senior monitors with in-house activities at their assigned office. Candidate CRAs deepen their comprehension on tasks and operations in the 1 – 2 months.

Thus, proficiency check test / monitor qualification test take place in approximately three months’ time. The certifications are granted to those who have sufficient understanding/proficiency in the training content and are recognized for their ability to execute the work. They start with accompanying senior monitors to sites and then they are assigned to a project. CRAs aim to improve their knowledge and skills continuously with OJT and follow-up training.

Introduction Training Content

• General Knowledge
  Pharmaceutical Industry, Drug Development Process, Business Manner, Duty of Confidentiality, etc.
• Regulatory Requirements of GCP and as CRA
  Description of Clauses of GCP, SOP Introduction, Pharmaceutical Affairs Act, etc.
• Drug Development Process
  Non-clinical Study, Clinical Study, Post Marketing Clinical Study, Application to Approval, Notice of Claimed Investigational Exemption, etc.
• Protocol Related
  Investigator's Brochure, Protocol, Monitoring Reports, Informed Consent Form, etc.
• Monitoring Operation
  Flows of Monitoring Operation (Investigator/Site Selection, Clinical Study Request, Flow of Clinical Study Contract, Activities during Site Monitoring Phase, Activities during Close Out Phase), Serious Adverse Event, Monitoring Report/Source Document Verification, etc.
• Monitoring Related Tasks
  Understanding of Medical Records, Clinical Study Fee, Understanding of Laboratory Evidence, Compliance/Noncompliance of Protocol, Quality Management/Assurance, How to Write Monitoring Reports, etc.
• Skill Training
  Business Documents, Presentation Skill, Monitoring Roll-playing, etc.

Follow-up Training

At Quintiles Academy, we aim to train and secure high standard CRAs at any time. Yearly, 50 hours of follow-up trainings are provided for certified CRAs to maintain and improve knowledge and skills.

• Updated GCP and SOP
  Description of Updated GCP and SOP, etc.
• Regular Follow-up Training
  Necessary Information for Operation (Compatibility Check, Insurance/Liability, How to Read Abnormal Variation on Laboratory Evidence, How to Read Electrocardiogram, Points on Clinical Trial Notification, MeDRA related, etc), Other Latest Updates, etc. 
• Case Study
  Issues and solutions Based on Actual Cases (site selection, case entry, collection of monitoring reports, actions against “deviation”/”noncompliance”, SAE, etc) to be shared 
• Skills Training
  Communication Skill, Presentation Skill, Problem-solving, etc. 
• Project Training
  Acquisition of Knowledge on Medicine and Disease, Understanding of Investigator's Brochure, Clinical Trial Notification, Monitoring Report, and Informed Consent Form etc, and Comprehension of Clinical Trial Schedule (including global clinical studies), as needed to execute a project
• Leader Training
  Understanding of the role to lead a project team (CRAs who are designated as a leader for the first time) 
• Medical Education
  Sectoral Lectures (e-learning)
  Lectures with textbooks and/or CD-ROMs, tests for measuring knowledge on medicine and disease (areas: organ of respiration, circulatory organ, kidney, internal secretion, metabolism, nerves, Hepato-Biliary-Pancreatic, gastrointestinal tract, blood, allergy, CTD, infectious diseases) 
• English Education
  Acquisition of English skills to assure global studies (General beginners, intermediate and advanced courses, medical English, TOEIC)