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Clinical Research Associate (CRA) skills benchmark launched by Cogent Skills

Cogent Skills, the sector skills council for the science-based industries has released a new Gold Standard for the role of clinical research associate.

The development of the Gold Standard role profile has been supported by experts in the field of clinical research including employers, several key training providers, lead bodies and the Medicines and Healthcare products Regulatory Agency (MHRA). It has been developed for clinical research associates (CRAs) and employers who in the execution of the CRA role monitor the progress of a clinical trials at investigator sites, verifying that it is conducted, recorded and reported in accordance with the protocol, and ensuring that the rights and wellbeing of subjects are protected.

CRAs are employed by clinical trial sponsors which may include pharmaceutical companies, contract research organisations (CROs) academia, the NHS and other institutions who must respond to a fast changing environment where maintenance of skills and knowledge is vital to the success of the role. The CRA Cogent Gold standard provides a framework that details these skills and the competency requirements that may then be used to recruit and develop new CRAs or develop structured training in accordance to future Cogent CRA training standards.

John Holton, Cogent Skills Director says, “As businesses grow, the impact of clinical and scientific knowledge evolves with the business. The new CRA Cogent Gold Standard will allow employers and individuals to benchmark themselves against a national standard so that they can recruit, develop or retain the best employees to a level recognised by employers as best practise.”

Extensive research has gone into the development of the CRA Gold Standard and thanks go to industry lead bodies and the Medicines Healthcare products Regulatory Agency (MHRA) for forming an ‘expert panel’ to agree the content of this new national standard. 

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