A Clinical Research Associate can quickly get promoted to become a Sr. Clinical Research Associate and then a Clinical Trial Manager.
The role of a Clinical Research Associate (CRA) is one of the very few roles defined clearly within the ICH-GCP guidelines. The primary responsibility of a Clinical Research Associate (CRA) is to monitor clinical trials that are ongoing at clinical trial sites.
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CLINICAL RESEARCH ASSOCIATE
A CRA may be employed directly by the sponsor companies of a clinical trials or by Contract Research Organizations (CROs) also known as Clinical Research Organizations that conduct clinical trials on behalf of the sponsor companies. Clinical Research Associates (CRAs) are also known as Clinical Trial Monitors. They have broad description of work however their main responsibility is to ensure that the rights, safety and well-being of subjects participating in clinical trials are protected. A Clinical Research Associate (CRA) acts as the main mode of communication between sponsors and the site. Clinical Research Associate (CRA) professional sets up, monitors and closes the clinical trial sites assigned to him/her. Based on the level of experience, CRAs are often hired at CRA Level I, II, and III by employers.
Some common on-job responsibilities of CRA’s are:
– Travel to and monitor clinical trial sites to make sure that ICH GCP guidelines, study protocol and applicable regulations are being followed
– Preparing site visit reports
– Ensure that only qualified individuals are working as site staff and that they are adequately trained
– Ensure data collected is accurate and verifiable
– Manage clinical trial site payments and handle any ongoing negotiations
– Ensure that the site has acceptable infrastructure and that it continues to remain so throughout the study
– Act as a mentor to site staff and provide continuous support and guidance
– Ensure appropriate filing of study documents and archival
Competencies & Skills:
Various competencies and skills are required to make a career as a Clinical Research Associate (CRA). Some of them are:
– Thorough understanding of the drug development process with sound knowledge of ICH-GCP
– Influential & assertive communication skills
– Ability to work under pressure
– Multi-tasking ability
– Ability to work independently
– Effective problem solving skills
– Decision making ability
– Eye for detail
– Graduation in Pharmacy or any Science related field is highly recommended
To work as a Clinical Research Associate (CRA) we suggest you consider the following online program(s):
– Post Graduate Diploma in Clinical Research
– To increase the number of opportunities for you, you may also choose one of the Advanced Post Graduate Diploma Programs in Clinical Research based on your preferred specialization
"To enroll at a JLI program was one of the best decisions that I made. I have recently got an opportunity to work with a CRO in my country. Thanks a lot for the support."
Clinical Research Associate