Clinical Research Associate (CRA)
A Clinical Research Associate (CRA) is a knowledge worker who performs CRA tasks.
- Context:
- They can interact with a Clinical Study Site Monitor.
- …
- See: Clinical Trials, Good Clinical Practice, Profession, Medical Research, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, Contract Research Organization, Academic Degree.
References
2023
- chat
- Q: How does a Clinical Research Associate (CRA) interact with a Clinical Study Site Monitor?
- A: A Clinical Research Associate (CRA) and a Clinical Study Site Monitor (CSSM) are both involved in monitoring the progress of clinical studies, but they have different roles and responsibilities.
The CRA is responsible for overall coordination and management of the study at the investigative sites. They are typically the primary point of contact for the study sponsor, and are responsible for ensuring that the study is conducted in accordance with the protocol and regulatory guidelines. They conduct site selection, initiation, monitoring, and close-out visits, and are responsible for ensuring that all study-related documents are accurate and complete.
On the other hand, the Clinical Study Site Monitor (CSSM) is typically responsible for day-to-day monitoring of the study at the investigative sites. They are responsible for ensuring that the study is conducted in accordance with Good Clinical Practice (GCP) guidelines and that all regulatory requirements are met. They typically conduct on-site monitoring visits to assess the quality of the data being collected and to ensure that the study is being conducted in compliance with the protocol, SOPs and regulations.
Both CRA and CSSM work closely together and communicate regularly to ensure the study is progressing well, and any issues are identified and addressed in a timely manner. The CRA will provide the CSSM with the necessary information and support to conduct the on-site monitoring visits, and the CSSM will report back to the CRA on any issues or concerns that are identified during their visits.
2021
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/clinical_research_associate Retrieved:2021-11-6.
- A clinical research associate (CRA), also called a clinical monitor or trial monitor, is a health-care professional who performs many activities related to medical research, particularly clinical trials. Clinical research associates work in various settings, such as pharmaceutical companies, medical research institutes and government agencies. [1] [2] Depending on the jurisdiction, different education and certification requirements may be necessary to practice as a clinical research associate. The main tasks of the CRA are defined by good clinical practice guidelines for monitoring clinical trials, such as those elaborated by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. A CRA would subsequently grow into a Feasibility Leader, Study Start up Leader, Project Manager, and Project Director at a Pharmaceutical company or a contract research organization. A CRA is usually required to possess an academic degree in Life Sciences and needs to have a good knowledge of good clinical practice and local regulations.
- ↑ Prospects, Clinical research associate. Retrieved 28 April 2014.
- ↑ McMaster University, Certified Clinical Research Associate. Retrieved 28 April 2014.
2019
- (Sauber & Sfera, 2019) ⇒ Chris Sauber, and Dan Sfera. (2019). “The Comprehensive Guide To Clinical Research: A Practical Handbook For Gaining Insight Into The Clinical Research Industry.” Amazon Digital Services LLC - KDP Print US. ISBN:9781090349521
- QUOTE: ... A Clinical Research Associate (CRA), also referred to as a monitor, acts as a liaison or middle person between the sponsor and the study site. This person’s primary role involves monitoring a clinical trial according to the study protocol, Good Clinical Practice regulations, and ensuring that both the needs of the sponsor and site are met. CRAs do not have any interaction with patients; instead, they check and review the data that the principal investigator and coordinators have collected in both the source documents and EDC. This is known as source data verification (SDV). The CRA also ensures that sites are adhering to the protocol and other applicable regulations by reviewing the source being collected for deviations. This is known as source data review (SDR). ...