Clinical research h associates (CRA) are said to be monitors for most of the time. This is the most famous position in CRO space and more people want to become CRAs. Especially the younger generation wants to become CRA because it’s the most flexible and remote position where they have to travel a lot and they love to travel. These travel or trips can be outside the country. They also make enough amount of money and many other benefits that make it the most attractive position. This is not an entry level position.
Positions that don’t travel:-
People having experience but are older, have families and other responsibilities goes into project management, lead CRA and clinical trial leads. These positions don’t include monitoring or travelling.
Purpose of CRA in CRO space is to go to each site on protocols to ensure that they are following GCP-ICH regulations and are in compliance with the protocols. They make sure if the site is making any mistakes in studies, documentations, patient enrollment and in timelines.
Their duties also include answering to all the queries from the sites regarding to the studies. These answers can easily be found on protocols but sites like to trouble CRAs to make it further reliable for them.
Risk based monitoring:-
CRO industry is moving toward remote direction as most of the work will be done remotely. CRA only have to visit the sites for risk based monitoring such as for adverse events, monitoring case report, checking the amount of dispensed drugs to the patients through IBRS system, electronic data for quality and accuracy. This saves a lot of money from travelling expenses.
Work close to study:-
CRAs work on the clinical operation side as they work closer to the sites performing research work. They work closely with the people at sites doing research study trials. Project management individuals don’t get many chances to get close to the research. CRAs make sure to collect all the documents, discuss with PIs and sub-Is and submitting all documents to CRO to put them into TMF.
Documents can be submitted to TMF directly by the CRA working remotely from the office but mostly is the CTA who submit files and documents into TMF.