The Clinical Research Associate, also known as a Monitor, is an individual that oversees the progress and conduct of a clinical trial. A clinical trial is implemented by investigators at a study site (hospital, clinic, or General Practice). The CRA is required to oversee the initiation, progress, and conduct of the clinical trial to ensure the scientific integrity of the data collected, and the protection of the rights, safety, and well-being of human study subjects. The CRA’s responsibilities include but are not limited to the following:
The CRA usually has a healthcare or science background to graduate level and above. The CRA is usually employed by a pharmaceutical company, contract research organisation, academic institution, or site management organisation. A CRA can work either in-house or in the field, sometimes requiring two to three days a week travelling. A field monitor will visit multiple sites and is the key interaction between Sponsor/CRO and the Investigator and Study Site Team.
Pharmaceutical companies are constantly seeking to reduce the development time necessary for their products to receive regulatory approval. Monitoring of a clinical trial is the first mechanism in identifying potential data discrepancies and regulatory issues. Inadequate monitoring can jeopardise the safety of the study participant and/or is a leading contributor to the delay in gaining drug approval. A well-trained and knowledgeable CRA is the pivotal role in protecting the study participant and helping to reduce the time between drug development and marketing approval. The demand for knowledgeable and trained CRAs continues to grow, however the supply is limited1. Phlexglobal offer a creative solution to meet this need.
1 Where Have All the CRAs Gone? CRfocus, Vol16, Issue 3, April 2005. The Mystery of the Missing CRAs, PharmaTimes, June 2005. Careers in Clinical Research, The Monitor, Vol10, Issue 4, Oct 2005
Current recruitment demands suggest that there is an acute shortage of CRAs in the industry¹. The need to fast track the graduate or new CRA into an effective self-starting competent CRA is heard more and more frequently. There now exists an opportunity for a rapid and sometimes competitive route to progress that exists alongside the slower conventional route; a fast track to promotion for the brightest recruits.
Phlexglobal has deliberately chosen to call its CRA Training Programme ‘Masterclass’, a term that implies learning given by an acknowledged expert in a particular field. We believe in promotion for the brightest recruits, yet we also understand that the best are driven by dedicated, long term, committed investment and support. By assisting the individual in achieving their career aim and acquiring detailed and entrenched knowledge of the area in which they work, we aim to assist the industry through providing the best possible candidates. Clearly, we are also investing in our own brand, as when the best reach the top, we expect that they will remember the origins of their pedigree.
The Phlexglobal CRA Masterclass© Programme embraces ‘real life’ learning. The student is put into real, albeit simulated, situations run with real life Investigators, Study Nurses, Pharmacists, peer CRAs, Statisticians, Data Managers, Study Managers, Auditors and clinical trial support staff. The classes allow for students to explore and examine best practice, to re-evaluate and address situations through repeat exercise, with no compromise to a real study, yet with real pressures and real timelines. In many cases these role plays may be harder than any situation they might later encounter. This combined with excellent academic tuition - tests not only theoretical knowledge, but communication skills, time management, assertiveness, ability to work under pressure and team building skills. The CRA cannot survive on knowledge alone and this knowledge-based and skills-focused approach offers the most effective blended learning. Masterclass trainers are subject to rigorous selection procedures. They demonstrate excellent training ability combined with exceptional knowledge and, with equal priority, they all have hands on experience of their specialist subject.
| Module | Topic | Facilitator |
|---|---|---|
| 1 | Role of the CRA | Jacqui Farnell/ Gareth Hayes |
| 2 | Essential Statistics | Caroline Whately-Smith |
| 3 | Protocol Development | Jacqui Farnell/Gareth Hayes |
| 4 | The Study Team | Jacqui Farnell/Gareth Hayes |
| 5 | CRF & Form Design | Jacqui Farnell/Gareth Hayes |
| 6 | Presentation skills & Investigator Meetings | Jacqui Farnell/Gareth Hayes |
| 7 | Monitoring Progress & Study Updates | Jacqui Farnell |
| 8 | Understanding the NHS | Sharon Boundy |
| 9 | Stress & Performance | Sharon Boundy |
| 10 | SCC/Research Nurse | Christine McGrath |
| 11 | Investigator | unconfirmed |
| 12 | Audits and Course Summary | Nigel Crossland |
2008 Dates:
Amersham
16th January (for 12 weeks)
7th May (for 12 weeks)