By Somaraju Lokaranjan, PM, i3 Research
Science graduates have always fared less in remuneration and benefits compared to engineering graduates. They have always wanted a career option in science which gives them a comparable salary and a steady career path. The average salary for a CRA ranges from 40,000 to 60,000 USD but is also country specific as per national standards and subsequently better within life science jobs.
Clinical Research is one of those career options which can fulfill your dreams and put you on an interesting career path with a faster growth ladder if you are the right person for the profile. There are examples in Industry where, in a span of five-six years entry level, CRAs have progressed to become project managers and higher related positions higher related positions.
The best way to enter this industry is through the position of a Clinical Research Associate or commonly called a CRA or Study Monitor. Although well established, most science graduates are not aware of this area and awareness programs need to be conducted at student forums and through other media.
With this background information, you will also need to understand the roles of a CRA, their job description, career prospects and, most importantly, how to initially get into the CRA job profile.
Let’s begin with understanding the CRA role and then enter into the area of requirements for a CRA job and how to get into the role in the best organizations of the Industry.
What is the role of a CRA?
The Clinical Research Associate has the responsibility of monitoring clinical research data on the study site where the research study is conducted. This is usually at hospitals and major clinics under the guidance of a reputed physician, commonly known as the Principal Investigator, and his team. A CRA provides assurance by monitoring the study research data that it is credible, verifiable and authentic. This will form the basis of establishing the new drug entity safety and efficacy in study population and supports its licensure to be used at a commercial level by regulatory authorities.
This process in brief is called Monitoring and definition as per ICHGCP Guidelines is as follows
ICH 1.68 The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
So the person who does the monitoring task is aptly known as a Monitor.
I am a science graduate. Can I become a CRA too?
The answer from my experience is No. So, then, what makes a CRA?
CRAs need the following educational skills and, most importantly, soft skills as listed below:
Educational Qualifications
1. The qualification requirement opens this area to a very large group of science and medical graduates which is the major advantage of this area.
2. The suitable candidate for this position can be anyone with a life science degree or a biomedical degree with backgrounds of pharmacology, pharmacy, biochemistry or medical doctor or a nursing degree but with a flair for understanding all relevant guidelines and niche for effective implementation of the same.
3. Full training will be provided before you can effectively monitor - in ICH-GCP and how this applies to working practices and SOPs at your employer’s business.
Soft Skills
1. The CRA role requires several soft skills, communication being a mandatory one. The CRA should have excellent oral and written communication skills as these form part of the main job trait. CRAs are rated based on this skill due to the need for them to communicate with different stake holders of the project.
2. CRAs must be able to manage time effectively and multitask as they can be pushed by time limitations and has to get high quality work done in the shortest time possible.
3. The third important skill is the ability to foresee risks in the project and take advance steps to mitigate them.
4. Negotiation skills are also paramount. CRAs will need to deal with a wide variety of budget and finance negotiations and should have this skill to influence others to the company’s advantage.
5. Another trait is the ability to deliver quality work under pressure. The majority of the time, CRAs can be allocated to more than one project or have several study sites to monitor and manage them but are required to still work with multiple issues and yet deliver results and complete review within the agreed timeframe.
6. The last important skill is the ability to travel 60-70% in a month. CRAs need to visit different sites for conducting the monitoring; there is a lot of travel involved. So flair for travel is required at least during the initial CRA years.
Once you possess all the above skills and qualifications, you want to know how to enter the industry and move into a CRA role. Read on...
Entry Options to the Clinical Research Industry
CRAs are employed in multiple organizations and first you need to understand how these organisations hire CRAs and how you can join the best of these organizations. Over the years, now due to high competition in this area, these options have increased. The present trend of organizations hiring CRAs is as follows:
Let’s first see the models and then we will discuss approaches to each option to gain a successful entry as each one is different from the other.
1. Employment in contract research organizations
2. Employment in site management organizations
3. Employment in major hospitals handling large number of studies
4. Employment in outsourcing organizations
5. Employment in pharmaceutical companies
6. Employment as freelance CRAs to multiple clients
We will look at each option in detail and discuss what you need to do to join organizations of your choice, understand advantages and disadvantages of each type of organisation which will help you to make a choice as per your background.
1. Employment in Contract Research Organisations:
Contract research organizations, or CROs, are the major employer of CRAs. The current trend of pharmaceutical companies is to outsource clinical research studies to CROs which are specialised and focused to conduct large multinational studies and have a large requirement of CRAs to work on their projects3.
Here are a few tips for applying to CROs:
1.1 Always choose large, multinational, global CROs as the first option. These provide excellent training and have a large variety of projects to work on and gain experience.
1.2 Prepare a list of CROs in your country and read the companies details and understand the performance metrics. Apply to the career section of the company website. Don’t expect an immediate response but when CROs get large projects they usually hire quickly and you may be the lucky one.
The downside to CROs is the CRAs need to work on multiple projects which brings in a lot of work pressure to perform quality work on tight schedules and may impact work/life balance. But remember these are the initial years of your work and you have to develop your ability to handle pressure.
2. Employment in pharmaceutical companies
For CRAs, the pharmaceutical industry is the next best bet for moving into CRA roles. This industry was initially the major employer of CRAs but because more and more studies are outsourced to CROs, pharmaceutical companies have fewer CRA teams in-house and instead found working through the CRO-based CRAs much more cost effective.
Even with this trend, it still employs the next highest pool of CRAs and offers an advantage to start level CRAs in gaining knowledge of various components of clinical trial management since these companies are sponsors of studies and manage the complete study set up.
The tips for joining pharmaceutical companies are similar to CROs as discussed above.
The downside is the need to work outside your CRA job description and be ready to get involved in various tasks of study management as a sponsor and site management but this also increases your knowledge on other components of clinical trial and how they are managed by the sponsor.
3. Employment in site management organizations
The growth of site management organizations (SMOs) in recent years has been phenomenal and this is pushed by aggressive competition to provide specialised and specific site management services and support. These organizations take away the pressure of close watch and follow-up from CROs/pharmaceutical companies and instead provide local support to a specific site and their study team to ensure that the clinical research study is conducted as per expected standards.
Here are a few tips to joining site management organizations:
3.1. SMOs prefer taking on fresh graduates compared to other organizations as they can mold them as per their specific requirements so you have a high chance here.
3.2 Prepare your CV in such a way that it shows that you are flexible to work in any role as SMO staff sometimes also need to work as a clinical research coordinator at the study site.
3.3 Look at the directory of SMOs in your country to apply to each of them separately.
4. Employment in major hospitals handling large number of studies
As noticed in the past few years, some major hospitals have conducted a high number of complex research studies and each successful study brings them more studies to conduct with the same investigator and site team. This large number of studies has paved a need for hiring CRAs who can coordinate the conduct of these ICH-GCP studies as per study sponsor requirements and also act as a vital contact for study management team4.
Here are few tips on how to join these hospitals:
4.1 Mark out hospitals in your country where you are aware that they conduct large clinical trials. An important source for this information is www.clinicaltrials.gov.
This website can provide international details of where studies are conducted and you can approach them for opportunities.
4.2 These positions require people with good communication skills because you will be dealing with various clients and also with reputed investigators.
5. Employment in outsourcing organisations
These clinical staffing companies hire CRAs and source them to CROs or pharmaceutical companies on a temporary or permanent basis. This offers organizations requiring CRAs a lot of flexibility to hire them at the time of the project need and can place them on other projects, as well.
These outsourcing agencies maintain a large database of CRAs and offer an advantage to CRAs as they take care of salary and benefits negotiations and guarantee the CRA a package as per Industrial standards.
There are very few organizations operating in this area and you need to spend a good amount of time learning about these organizations online.
The downside is that since these are contractual positions, you may not get a long-term career if you wish to do so.
7. Employment as freelance CRAs to multiple clients
This option provides you with a lot of freedom to choose your clients and work with multiple clients. This also offers the advantage of earning more money since you as an individual are contracted to a project rather than an organisation.
There are several disadvantages with this option even though it offers financial and operational freedom. The significant one to note is that most of the organizations opt for a freelance CRA only in countries or a region where there is scarcity of clinical research professionals and these regions are out of reach for organizations to set up their own countries or don’t foresee much business coming through these regions.
So this may limit your scope of opportunities and this option usually is not preferred for fresh graduates as organisations always prefer an experienced freelancer. So this is something you can opt for after few years of Industry experience.
If you want to get into a freelance role and tell the world that you are an individual who is available for freelance then you need to advertise yourself and send your profile to organizations and keep a constant follow up to check for good opportunities.
Before I wish you best of luck in your search for an ideal CRA position, I also want to add that while CRA certifications and Clinical Research courses are widely popular, they also better your chances of getting a CRA job faster. The important point to understand is that working as a CRA will be manageable only if you have the set of soft skills discussed above. The training program can only enhance your knowledge of the Industry but will not enable you to do the job of a CRA without these skill sets.
Remember the monitoring work you do as a monitor is going to support approval of a new drug which will be used by millions of people later so you have a major responsibility on hand to get it right every time with the right approach and skill set!
References
1. www.Payscale.com
2. http://www.clinicaldiscovery.com/readArticle.aspx?articleId=44Reference 1
3. http://yourfirstpharmajob.com/2008/10/28/what-is-a-clinical-research-associate-cras-job-all-about/
4. http://www.biohealthmatics.com/careers/PID00251.aspx
5. 5. http://yourfirstpharmajob.com/2009/02/11/the-future-of-cra-jobs/
About the Author
Somaraju Lokaranjan is Project manager at i3 Research. Contact him at +914040155187 Or Email: Somaraju.Lokaranjan@i3global.com.
Check out the latest Career Insider eNewsletter - July 14, 2010.
