A clinical research associate (CRA) is a healthcare professional who manages clinical trials and studies to ensure that they are conducted in compliance with regulatory requirements and company procedures. The CRA works with a team of investigators, sponsors, and regulatory authorities to ensure that the trial is conducted safely and effectively.
Example job brief: We are seeking a clinical research associate to manage clinical trials and studies for our healthcare organization. The ideal candidate should have a degree in a relevant field, such as life sciences or nursing, and at least 2 years of experience in clinical research. They should have strong communication, organizational, and analytical skills, and be able to work well in a team environment.
Main responsibilities of a clinical research associate:
- Design and implement clinical trial protocols
- Monitor the progress of clinical trials and ensure that they are conducted according to protocols
- Collect and analyze clinical trial data
- Write reports on clinical trial results and submit them to regulatory authorities
- Develop study budgets and manage study expenses
- Train and supervise study staff
- Ensure that the study is conducted in compliance with regulatory requirements and company procedures
- Manage and maintain study records and documents
- Manage study site communication and relationships
- Attend conferences and meetings related to the study
Main requirements of a clinical research associate:
- Bachelor's degree in a relevant field, such as life sciences, nursing, or pharmacy
- At least 2 years of experience in clinical research
- Knowledge of clinical trial design, protocol development, and study management
- Understanding of regulatory requirements and good clinical practice guidelines
- Strong communication, organizational, and analytical skills
- Ability to work well in a team environment
- Attention to detail and accuracy
- Proficiency in Microsoft Office and data management software
- Familiarity with clinical trial software and databases
- Ability to travel to study sites as needed
Frequently asked questions about the role of a clinical research associate:
- What is the educational requirement to become a clinical research associate?
- A bachelor's degree in a relevant field, such as life sciences, nursing, or pharmacy is typically required.
- What skills are important for a clinical research associate to have?
- Strong communication, organizational, and analytical skills are essential, as well as attention to detail, accuracy, and the ability to work well in a team environment.
- What is the role of a clinical research associate in clinical trials?
- The CRA is responsible for managing clinical trials and studies to ensure that they are conducted in compliance with regulatory requirements and company procedures.
- What regulatory requirements must clinical research associates be familiar with?
- Clinical research associates must be familiar with good clinical practice guidelines, as well as regulations set forth by governing bodies such as the FDA and ICH.
- What software tools do clinical research associates typically use?
- Clinical research associates may use a variety of software tools, including clinical trial software and databases, as well as Microsoft Office and data management software.
