Best Clinical Research Associate consulting skills

Do wonder what are the best consulting skills for a Clinical Research Associate (CRA) ? Read on!

Definitely, you should take every opportunity to make sure that you reach the highest skill level you can as a CRA. The more of these skills you have, the easier it will be for you to succeed as a consultant. The skills of a consultant and a CRA overlap. In fact, if you are really good CRA, you will probably do very well in consulting.

A day in the life of a Clinical Research Associate (CRA)

What do CRAs do on a daily basis? Kunal Shah, based in India, wrote an article about this and it reflects that a day in the life of a CRA is much the same across the world.

A CRA monitors clinical trials to ensure that they are done properly according to the protocol, standard operating procedures, contracts and regulations. To me, CRAs (also known as clinical monitors) deal with such a wide range of tasks and issues that it is mind-boggling.

CRAs produce study documents, such as protocols, informed consent forms, and case report forms (CRFs), and do many other tasks. They evaluate the suitability of clinical sites, visit sites and train study personnel. Also, CRAs monitor sites to check that they are actually carrying out the study properly. Their work is both varied and extremely detailed.

CRAs are the eyes and ears of the sponsors of the study. So often they are the first to raise the alarm, when problems or potential issues are discovered. They frequently find these during site calls or visits or when viewing the data or study documents.

What skills are best for a CRA?

The skills you need can vary with the types of studies, the diseases under investigation, the type of organization (e.g., a pharmaceutical company, university, or a contract research organization (CRO)).

One way to get a good handle on the skills you need is to search job postings and look at the job descriptions for CRAs or clinical monitors in your preferred type of organization.

You can find an interesting approach to what are the most needed skills for CRA on Resume Worded. They identify the most common keywords that appear on CRA job postings and have a free targeted resume tool to help you make sure that you do not miss keywords that resume screeners use. Of course, you can only include skills you have in an actual application, but this way of doing things can point out new skills and knowledge you might need to acquire to be competitive. They focus on hard skills rather than soft skills, such as interpersonal skills.

The skills Resume Worded lists include:

• Good Clinical Practice (GCP)
• Clinical Monitoring
• Clinical Trial Management System (CTMS)
• Electronic Data Capture (EDC)
• Clinical Trials
• Clinical Research
• Protocol
• Clinical Development
• CRO Management
• Oncology
• Clinical Research Associates
• Clinical Data Management
• Standard Operating Procedures (SOP)
• Therapeutic Areas

To read the full list, you need to sign in to their site. They also have an artificial intelligence tool, where you can paste your resume and it will tell you what competitive keywords your resume is missing.

The partial list above is interesting because of gives an idea of what are the most commonly sought skills, and for example, that oncology is an area with a large number of trials.

You can also get an idea of important skills by finding out what sorts of interview questions are asked of CRA job applicants.

How do you get the skills you need as a CRA?

On the job training is best.

Many organizations, especially CROs have training when they bring CRAs on board. You can also become certified in electronic data capture (EDC) with vendors such as InForm / Oracle and Medidata / RAVE, and others. You might also do these EDC trainings at the request of clients, who will often pay for them, if they need you to be a user to carry out your consulting. If your clients offer to pay for these certifications, because they think it might be useful, they are worth doing. Otherwise, it is costly to do these certifications on your own.

Taking courses is important, too.

You can take courses in each of the areas above, such as GCP, data management, and about clinical trials, how they are designed, conducted and monitored, and all of the relevant regulations. Look for free courses online. For example, for GCP, see three options through the National Institutes of Health and also through PharmaLessons.

The FDA provides training and continuing education and webinars. PERI has courses on clinical development.

The number of organizations, educational institutions, and online resources for training continues to grow. You will find that it is worthwhile searching online for useful courses.

Stay up to date in your field, and join professional organizations.

DIA has many relevant courses for CRAs. So do the the Society of Clinical Research Associates (SOCRA) and the Association of Clinical Research Professionals (ACRP).

Increase your proficiency in the use of commonly used software.

Most CRAs use Excel spreadsheets for trackers. Also, it certainly helps to be highly proficient in word processors, such as Word. Proficiency in MicroSoft Office products are very frequently required by employers. Besides Word and Excel, these include PowerPoint for presentations and SharePoint. Learning Tree International has courses on advanced use of Excel, and other areas relevant to CRAs. They also have courses on project cost and management,

Find gaps in your skills and training

CCRPS has a complete guide on how to become a CRA. Their courses are a resource for you if you are get started or want to become a CRA. It is also helpful for finding gaps in your training if you are established. Also, they have relevant courses in clinical research, pharmacovigilance, and other areas of interest to CRAs.

How to get and improve your consulting skills

Consulting skills are covered in detail in my blog post: How to improve your consulting – Deliberate practice? These include hard and soft skills.

• Communication skills such as writing very well and making excellent presentations are covered with tips and resources for attaining them.
• Soft skills such as interpersonal skills.
• Teamwork (interestingly, can be improved through a scientific approach).
• Quantitative, analytical, problem solving, and project management skills.
• How to prepare consulting proposals.

Making the transition to consulting

You can move to consulting as outlined in my posts How to move into independent consulting as a Clinical Research Associate and How to move to independent consulting in clinical operations.

It helps to have mentors for your career as a CRA and as a consultant. These are people who have your back and who can guide you. Mentors can point out gaps in your knowledge and skills and help you to find opportunities.

Conclusion

Many of the best skills for consultants overlap with those of CRAs. Work on improving your skills through feedback from others, attending courses and professional meetings, and taking advantage of the many resources online.

I hope this has been useful to you.

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