Transforming Your Clinical Research Associate Expertise into an Independent Consultancy Venture

As a Clinical Research Associate (CRA), you are no stranger to the intricate web of clinical trials, monitoring, and data management. Your role is integral to ensuring that trials operate smoothly and adhere to stringent guidelines. But have you ever considered transforming your CRA expertise and skills to an independent consulting venture?

If the prospect piques your interest, this brief roundup of articles on this site will provide an overview on transitioning from your CRA job to an independent consultant.

1. Harnessing the Experience: When Are You Ready?

“Opportunity doesn’t make appointments, you have to be ready when it arrives.”

Tim Fargo

1.1 Gauging Your Expertise

Before considering the leap into consulting, you must evaluate your experience and proficiency as a CRA. The depth and breadth of your expertise will dictate your success as a consultant.

• Have you cultivated a reputation as a dependable resource in your organization?
• Are recruiters attempting to lure you away from your current role?
• What are your strengths and weaknesses as a CRA?

Reflect on these questions to gauge your readiness.

1.2 Expanding Your Skillset

In some cases, bolstering your credentials with additional training could provide you with a competitive edge. Consider pursuing courses that expand your knowledge in your field and keep you up to date the latest developments. For instance, DIA offers a variety of relevant courses.

Membership in professional organizations, such as the Society of Clinical Research Associates (SOCRA) and the Association of Clinical Research Professionals (ACRP), can provide access to invaluable resources, updates, and certifications.

2. Carving Your Niche: What Will You Offer?

“If everybody is doing it one way, there’s a good chance you can find your niche by going exactly in the opposite direction.”

Sam Walton

2.1 Defining Your Niche

In the diverse world of CRA consulting, consultants often specialize in certain areas. Some operate independently as CRAs for Contract Research Organizations (CROs) or pharmaceutical companies, while others provide higher-level advisory services, for example, addressing issues with non-compliant or problematic clinical research sites. So at a superficial level, it is clear that you need to define your niche.

I have addressed how to define your niche in more detail in the article: Standing Out From the Crowd: A Guide to Defining Your Niche as an Independent Consultant. It requires some soul-searching to define your strengths and passions, and market research to identify gaps that others are not fulfilling. This will help you to narrow down your niche to give you the best chance to compete. Once you have defined your niche very clearly, you can build your personal brand around it.

2.2 Building Your Network

Remember, the relationships you’ve built in your role as a CRA can be instrumental in securing referrals when you transition into consulting. The individuals who enjoyed working with you, those you interacted with at team meetings, site initiation visits, and investigator meetings, can become your potential leads.

In the article, Building a Strong Referral Base: The Best Ways to Network as a Consultant, I suggest some strategies for building a client base.

3. Structuring Your Business: Laying the Groundwork

“If you have built castles in the air, your work need not be lost; that is where they should be. Now put the foundations under them.”

Henry David Thoreau

3.1 Planning Ahead

When you feel prepared to transition to independent consulting, it’s crucial to establish your business framework first. Being an independent consultant or contractor as a CRA is a business endeavor. Therefore, you must follow a systematic approach to form a business and commence your consulting journey.

3.2 Learning from Others

Drawing insights from others’ experiences can be incredibly enlightening. Consider exploring accounts based on experiences about moving into consultancy or freelancing, like:

• So you want to be a consultant?
• Learning about consulting
• How to move to independent consulting in clinical operations
• How To Transition to Freelancing from a Full-Time Job

I have written about my own experiences as a physician, moving from academic clinical research to industry and then making a transition to independent consulting.

4. Building on your CRA Role: A Day in Your Life

4.1 Monitoring and Ensuring Compliance

As a CRA, you are well aware of the pivotal importance of your primary role, which is to monitor clinical trials and ensure adherence to protocols, standard operating procedures, contracts, and regulations. Your expertise is vital to identifying potential issues and resolving them promptly.

4.2 Producing Study Documents and More

Beyond monitoring, as a CRA, you handle a variety of tasks. You create study documents like protocols, informed consent forms, and Case Report Forms (CRFs). You, evaluate clinical sites’ suitability, conduct site visits, and train study personnel.

What your actual experience is as a CRA will be important in considering what path you take as a consultant and how to prepare for the transition.

5. Identifying Key CRA Skills: What You Need?

5.1 Hard Skills

Certain skills are crucial for a CRA. These include Good Clinical Practice (GCP), Clinical Monitoring, Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), and understanding of Clinical Trials. Tools like Resume Worded can help identify the most common skills required in CRA job postings.

5.2 Soft Skills

Beyond hard skills, soft skills, like communication, interpersonal skills, and teamwork, are equally important. These can be honed over time and can significantly affect your effectiveness as a CRA and a consultant.

6. Enhancing Your Skills: The Road to Improvement

6.1 On-the-Job Training

The best way to improve your skills as a CRA is through on-the-job training. Many organizations offer training for new CRAs.

You could also consider getting certified in electronic data capture (EDC) with vendors like InForm/Oracle and Medidata/RAVE, if the opportunity arises in your job. Here is a review of the best EDC software.

Your employer may support training in project management, budget management, and in the use of a wide variety of software applications.

6.2 Opting for Courses

Photo by Mikael Blomkvist

Courses are another avenue to improve your skills. In addition to resources mentioned above in 1.2 Expanding Your Skillset, for instance, the FDA provides training and continuing education and webinars. Also, you can find courses through universities and on Udemy and Coursera. Online resources for training are growing, making it easier to find useful courses.

Remember to include in your learning topics that will help you to make the make the transition into consulting.

7. Consulting Skills: How They Align with CRA Skills

7.1 Hard Consulting Skills

Hard skills like quantitative, analytical, problem-solving, and project management skills, which are crucial for consultants, align well with the skills of a CRA.

7.2 Soft Consulting Skills

Similarly, soft consulting skills, like communication (for example, asking the right questions and active listening) and interpersonal skills, are also required for a CRA. Moreover, preparing consulting proposals is a skill that can be beneficial in both roles.

As you move into establishing a consultancy, your clients can provide valuable feedback that will help you to enhance your consulting skills.

8. Transitioning into Consulting: Making the Move

“We keep moving forward, opening new doors, and doing new things, because we’re curious and curiosity keeps leading us down new paths.”

Walt Disney

If you’re considering transitioning into consulting, mentors can be a great resource. They can guide you, help identify gaps in your skills and knowledge, and assist you in finding opportunities. Ideally, you would someone who has made the transition to consulting and has years of experience as a consultant. This could be a CRA, clinical operations manager, or perhaps a clinical researcher.

Consider though, that you might need a business mentor, too. Someone who can guide you in setting up your business. For those of you in the United States, the Small Business Administration (SBA) can help you find such mentors.

Also, if you are a woman, and you start a small consulting business, you might consider consider applying to the SBA for Women-Owned Small Business (WOSB) certification. This can help you to be more competitive in competing for government contracts (and also in the private sector). I have written about this in the article: Shattering Glass Ceilings in the Startup World: How WOSB Certification Can Give Your Consulting Business the Boost it Needs.

9. Conclusion: Merging the Skills

The best skills for consultants often overlap with those of CRAs. Work on improving your skills through feedback, attending courses, and professional meetings, while utilizing online resources.

Remember, your success as an independent consultant is a direct result of the expertise you’ve cultivated as a CRA.

10. Your Feedback: I Want to Hear from You!

Your feedback is invaluable to me.

What topics would you like me to cover?

What are your questions?

Please let me know!

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