Addressing the crisis facing the Clinical Research Staffing market
SummaryThe Healthcare Industry is currently experiencing the effects of a global shortage of qualified and experienced clinical research professionals – and this situation has evolved into the industry’s very own version of ‘Catch 22’. While employers are looking to hire candidates who are already experienced in the practice of clinical research, new Life Science graduates and others wishing to start on a career in the Healthcare Industry are unable to gain such experience without first being hired.
The Healthcare Industry is currently experiencing the effects of a global shortage of qualified and experienced clinical research professionals – and this situation has evolved into the industry’s very own version of ‘Catch 22’. While employers are looking to hire candidates who are already experienced in the practice of clinical research, new Life Science graduates and others wishing to start on a career in the Healthcare Industry are unable to gain such experience without first being hired. This is the crux of the dilemma that faces new entrants to the clinical research profession as well as the employers with vacant clinical research positions to fill. DOCS International in partnership with the Institute of Clinical Research (ICR) have jointly launched the Clinical Research Academy (CRAcademy), which signals a determined and innovative attempt to address the predicament facing the Healthcare Industry. With the inauguration of CRAcademy, the time for talking around this issue has come to an end and the time for action has arrived.
CRAcademy Traineeship content
Since 1 April 2005, CRAcademy has begun to arrange Traineeships for starter clinical research professionals by placing them with Healthcare Industry sponsors wishing to make a sound investment in the future. A core element of the Traineeship is participation in the accredited ‘Introduction to Clinical Trials Practice’ course run by ICR. This course covers the basic elements of clinical research and its regulatory framework, and delivers training in the practical skills fundamental to successful clinical trial management (Box 1). As a vital adjunct to the course, the theory and skills acquired are then applied, reinforced and tested in a practical setting. Trainees will accumulate hands-on experience by assisting the sponsor with administrative and support tasks while being given exposure to the clinical research workplace.
Outline of ‘Introduction to Clinical Trials Practice’ course:
• Drug development
• ICH-GCP and EU Clinical Trial Directive and local drug laws
• Source data verification and clinical trial monitoring
• Clinical trial design and theory workshop
• Statistics for CRAs
• Ethics committees and informed consent
• Investigator selection and motivation
• Adverse effects and adverse drug reactions
The final examination consists of a theoretical and a practical part: these are designed to test the trainee’s broad grasp of the essential aspects of clinical research and do not focus solely on guidelines and regulations.
Throughout the process, trainees are closely coached and supported by a Clinical Team Manager from DOCS International. The Clinical Team Manager provides support both in overall professional development and in orientation in the working environment. The Traineeship Manual enables the trainee, client and Clinical Team Manager to work in a structured and comparable manner, thus ensuring successful graduation from CRAcademy. On completion of CRAcademy, trainees will achieve specific learning outcomes and be able to demonstrate the skills and competences listed in Box 2.
Within CRAcademy, DOCS International is responsible for identifying, attracting, assessing and selecting trainees and trainee coaching and support. Each trainee will be carefully selected to meet each individual client’s requirements. ICR will run the ‘Introduction to Clinical Trials Practice’ course, co-develop the Traineeship Manual, and administer the final examination on conclusion of the Traineeship.
CRAcademy graduates will be able to:
• Prioritise based on patient safety, data integrity and protocol requirements
• Perform the basic tasks of SAE reporting and consent procedures
• Prepare and conduct site visits according to GCP and company SOPs
• Demonstrate practical skills such as effective planning, time management and priority-setting
• Practise the basic tasks involved in drug accountability and source documentation verification
• Demonstrate resolution of practical problems on site
Benefits for trainees and sponsors:
By providing a highly visible entrance into clinical research, CRAcademy will help to remedy the current shortage of professionals with the kind of experience that is high on any employer’s wish list. The CRAcademy platform is on a scale that will provide significant numbers of these valued Clinical Research Professionals, both in the United Kingdom and across Europe.
Completion of a CRAcademy Traineeship, with its emphasis on hands-on experience coupled with a clear understanding of the basic elements of clinical research, will provide trainees with a solid platform for future career development in the Healthcare Industry. Aside from the opportunity to gain relevant work experience with respected sponsor organisations, the benefits to CRAcademy trainees include ongoing professional coaching and career support; basic compensation during the Traineeship, quickly progressing to full salary benefits; and an immediate start on a career in clinical research.
For clients, CRAcademy supplies the ‘right’ trainees by carefully identifying, screening, interviewing and selecting candidates, matching them against detailed profiles. It will also share with sponsors the time-consuming task of supporting starters through their initial months of employment, training and development. Additionally, sponsors will have the reassurance that CRAcademy graduates have followed a structured orientation and development programme and have successfully completed the accredited and well-established ‘Introduction to Clinical Trials Practice’ course. By increasing the available pool of skilled clinical research staff, those companies and organisations sponsoring trainees in CRAcademy will demonstrate their forward-thinking attitude to investing now in the clinical research professionals of tomorrow, thus enhancing their own reputation both in Europe and further afield.
CRAcademy – the future
The two founding partners – DOCS International and ICR – are convinced that CRAcademy will successfully and effectively facilitate the transition from tertiary education into the Healthcare Industry by offering a practical way out of the impasse that is currently hampering new entrants. Through the provision of specific training and professional support, CRAcademy will give trainees a head start towards a successful career in clinical research. At the same time it will provide positive gains for sponsors wishing to invest now in a sound future for their organisation. Although the content of the Traineeship is currently focused on the development of Clinical Research Associates (CRAs), there are plans to broaden the scope of CRAcademy to encompass other professional groups within clinical research, for example, data managers and project managers. CRAcademy therefore has all the potential to effectively abolish the gap between supply and demand for clinical research professionals. If this goal is achieved, CRAcademy will ensure that – as far as Healthcare Industry resourcing is concerned – ‘Catch 22’ is moved back to its rightful place in the realm of fiction.