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

News Release April 2016

Redtree People have assisted Cogent Skills, the sector skills council for the science-based industries, with the development and release of the 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 headed by Sue Fitzpatrick of Redtree. The expert panel included sponsor Pharmaceutical employers; providers Redtree and leading industry bodies such as 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.

Sue Fitzpatrick Redtree People Director commented, “The new industry Gold Standard now exists to unify sector skills so that CRA competencies may be measured and supported by quality approved training. I am very pleased to be involved in the process and creation of new standard which has been long awaited”

RAs 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 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 practice.”

Redtree has long canvassed industry bodies for the introduction of a standards based approach for clinical research and is delighted to be working with Cogent to push these unified standards forward. In its training and learning capacity, Redtree will provide Gold Standards aligned training after being instrumental in the delivery and development of the new Training Standards to meet the Gold Standard.

About Gold Standard

The Gold Standard is a Competency Framework for individuals in the science based industries. It sets an aspirational industry standard for expected levels of on-the-job performance. It supports individual Continuing Professional Development (CPD), setting out the skills required for world class performance in key job roles.

Through this framework individuals can be confident that their skills have been benchmarked to a national, industry-developed standard. The framework describes and maps the competencies required to a wide range of jobs across four areas of competence.

The Gold Standard Framework is widely adopted across the science industries having been adopted in Europe as a skills benchmark in the science based industries.

About Redtree People

Redtree People is an organisation focused on skills and skills development in the Clinical Research sector. It aims to help, grow and assist with the career development of its registrants (Redtree People) to ensure they are best equipped for career development and compliant for industry best practice.

About Cogent Skills

Cogent Skills is the UK’s strategic body for skills in the science industries, led by sector employers. We work with them to develop, design and deploy skills solutions for the science industries.

All our products and services are designed with science industry employers, are underpinned by national standards and meet the unique requirements of the sector.

Industries covered include chemicals, polymers, biotechnology, life sciences, pharmaceuticals, healthcare, bio medical technologies, environmental technologies, bio medical devices, nuclear and organisations that devote the majority of their efforts in the various stages of research, development, technology transfer and commercialisation.