Career as a Clinical Research Associate

"At a time when the global economic slowdown has made the future of many youngsters uncertain, there is a silver lining in the form of clinical research," says Dr. Piyush Juneja, a former clinical research associate and now a project manager at Max Neemans International, India’s leading clinical research organisation. MBA in Project Management from Sikkim Manipal University, Dr Juneja shares some industry insights.

What is the job of a Clinical Research Associate (CRA)?

A clinical research associate (CRA) sets up, monitors and completes clinical trials.

The clinical trials are scientific studies of the effects, risks, efficacy and benefits of new and existing medicines. Trials need to be carried out before a product reaches a hospital or the shelves of the local pharmacy. They are undertaken at various stages, or 'phases', and include: trials on healthy humans; trials on patients with a disease; and studies conducted after the launch of a new product to monitor safety and side effects during large-scale use. Clinical trials are conducted by pharmaceutical companies or Contract Research Organisations (CROs) on their behalf.

Why should students opt for CRA as their career option?

The demand for clinical research associates in the industry is high and thus the chances of getting a good job are also high. It is true that every learner coming to this field is job-oriented. However, if you want a job quickly after completion of your regular or online course, opt for a career option where you can work as CRA.

What is the eligibility to enter this field?

A bachelor’s degree in Science is mandatory. Any professionals from CRO (Clinical Research Organisation), pharmaceutical, bio-tech, practicing doctors and fresh graduates can apply.

What are the specific skills required for the job?

• Eye for detail
• Keen observation
• Should know how to deal with people
• Should know how to extract work
• Should possess soft skills
• Should be able to adapt to various cultures

How has the industry fared till now?

Today, India provides a favourable environment for the conduct of global clinical trials as there is an inherent advantage of cost, speed and quality. The value for clinical trials outsourced to India is soaring high and is expected to reach US$ 2 billion by 2012. With nearly 50-60% cost saving associated with conducting clinical trials in India, large number of foreign and private pharmaceutical, bio-technology and contract research organisations are expanding their operations to Indian shores. And being a sunrise industry, the field is offering exciting career prospects along with accelerated growth path to medical students.

What are the growth prospects and pay-scales?

Initially, students start off as a Clinical Research Coordinator/ Clinical Research Associate/ Pharma Co vigilance associate (PVA)/ Research Associate (RA) and earn around Rs 10,000-Rs 20,000/month.

After acquiring an experience of 2 years, they go on to the next level of becoming a Senior Clinical Research Associate/PVA/RA earning something around Rs 25,000 – Rs 40,000 per month.

With an experience of three years, they proceed to the next level i.e. Project Manager/Team leader/Quality Assurance (QA) associate. At this stage, they earn around Rs 35,000 to Rs 65,000/month.

The next stage is that of a Manager – Clinical operation/QA/PVA/RA which requires an experience of 5-7 years. As a manager clinical operation, individuals can earn something between Rs 80,000- Rs 1,00,000/month.

Lastly, individuals end up acquiring the position of a Director or Vice-President with an experience of 7-10 years. At this level, the pay scale goes up to Rs 3,00,000/month.

What are the pros and cons of the job?

Pros:

• Good for people who love travelling
• Challenging
• Meet new people
• Good networking with various hospitals
• International exposure as most of the clients are from US and UK

Cons:

• Travelling (10-15 days)
• No fixed working hours
• Personal life gets affected
• As clients are from US and UK, you have to wake up and work late night

What is your daily schedule like? Can you paint a picture of an average day of a CRA’s life?

5am – 7.45 am: Preparation for the site visit. Reading trial related paperwork.

11.20 am: Arrive at site and speak with the research staff to arrange a suitable time for the research nurse to discuss trial issues.

11.30 am: Study all the Investigator Site Files (ISF), case notes and any other trial related paperwork and log on to the trial website I will be working from.

11.40 am: The first thing I always check whilst monitoring at site is whether there have been any serious adverse advents (SAEs). Secondly, I check as to whether there have been any new patients consented. Thereafter, I take necessary actions required.

1 pm: Check that the ISF is up to date with all necessary paperwork, and file any new or updated documents. Ensure that the information is in the correct section (as per ICH-GCP section 8). Make a list of any missing or out of date files which either the sponsor company or the site are required to provide. Update the essential documents checklist to be sent to the sponsor on completion of my monitoring visit.

3 pm: Verify information which has been put into the e-CRF against the source documents (case notes, lab reports etc) for all patients. Take notes for all the information which I look through.

4.30 pm: Meet with the research nurse and/or site investigator to discuss progress to date with recruitment, any staff or resource changes at site and highlight any missing or incorrect data. The role of the CRA includes providing support and encouragement to the site staff and I enjoy having a good rapport with the staff.

5 pm: Continue to verify information against the available source documents.

6 pm - 8 pm: Leave site for the day

Other interesting reads:

• Know all about Clinical Research and Trials!
• Science graduate? Take up clinical research!