New Employee Standard for a Clinical Research Associate

Redtree have worked with various industry agencies to promote the need for an employee standard for the job role of a Clinical Research Associate. The CRA Standard will define the skills required to perform the role to best industry practice.
Professional employee standards have to be developed by the industry, at the request of the industry. Currently the new Trailblazer group, including sector companies, are working with other providers to create a high level apprenticeship in the area of clinical which Redtree firmly supports.
The emergence of the new standard will form the basis for new training provision to be aligned the standard.
Redtree look forward to assisting employers with the confidence that the its standards aligned training will deliver the skills they need.

About the Employee Standard

The new Employee Standard is a Competency Framework for individuals in the science based industries. It sets the skills benchmark for excellence in skills and 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 bench-marked 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: Technical Competence, Business Improvement,Compliance and Functional & Behavioral. These Standards and frameworks are widely adopted across science based industries having been adopted in Europe as a recognised skills benchmark.

Why is there a need for a single standard ?

The regulatory frameworks that surround the clinical research sector are well known, yet unlike the other sectors across life sciences, clinical has never had an unitary agreed standard to measure the competency and skills of its workers operating in the sector. This has led to a plethora of providers claiming authority and sometimes doubtful accreditation’s, leading to confusion and duplicity in the market.

The new standard removes this problem and will provide clinical professionals clear guidance in terms of new talent entry and career and workforce development. Redtree have lobbied industry bodies and the industry itself to help pioneer the development of the standard and are now very pleased to offer its training solutions aligned to the new standard.

Employers use the standards in a number of different ways:

 Benchmarking against an industry standard

 Ensuring individuals are trained to industry best

 Identifying skill gaps

 Producing training plans

 Recognising existing skills

 Recruitment and succession planning

 Development discussions

 Setting aspirational targets

The Clinical Research Associate standard is being approved by the expert group.

The Trailblazer expert group consisted: pharmaceutical companies, CROs, key training providers who will seek input from lead regulators The Medicines & Healthcare Products Regulatory Agency (MHRA).



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Redtree Gold Standards Press Release

Cogent Press Release

Redtree Gold Standards flyer