Have you ever heard about a Clinical researcher? You might have, though. A clinical researcher or clinical trial assistant is a person who works in the pharmaceutical, biotechnology, and medical device industries to test whether a drug candidate is safe and effective in humans.
Where can you work?
Clinical trials are done with patients who have a certain disease or condition to test the safety and effectiveness of drugs. A clinical researcher works in clinical research departments at drug companies, medical schools, teaching hospitals that participate in phases 1-3 of FDA's clinical trial program.
Key aspects
A clinical researcher usually works with a team of 100 - 200 individuals ranging from nurses, social workers, doctors, statisticians, lab assistants, etc. Research associates also work with laboratory animals for toxicity tests. Such teams are called Clinical Research Organizations (CROs).
The basic idea behind using animals for testing the safety of new compounds is that they share over 90% of their genetic makeup with humans; hence results obtained can be extrapolated to humans. Furthermore, it costs far less money to do pre-clinical animal studies than human trials.
The main objective of a clinical researcher is to make sure that potential new drugs or treatments are safe and effective before they are made available to patients. Clinical trials can be classified into four phases:
Phase I: This is the first time a drug is given to humans. The aim of this phase is to find out if the drug is safe and whether it has any side effects.
Phase II: In this phase, the drug is given to a larger group of people to see if it is effective in treating the disease or condition it is meant for.
Phase III: In this phase, the drug is given to even more people to see if it is safe and effective.
Phase IV: This phase only takes place after the drug has been released for public use. The aim of this phase is to monitor the side effects of the drug and see if it is causing any harm.
So what does a day in the life of a clinical researcher look like?
Well, it can be quite varied as clinical researchers are involved in all aspects of the research process from designing the study, to collecting and analyzing data, to writing reports and presenting their findings. They may also be involved in regulatory affairs such as obtaining approvals from ethics committees or regulatory agencies.
On a day-to-day basis, they may spend time in the laboratory carrying out experiments, or they may be meeting with patients or other healthcare professionals to discuss the details of the study. They also need to keep up with current literature in their field of research.
Who is qualified for the job?
A bachelor's degree in life science, biology, chemistry or biochemistry. Some universities offer an accelerated master's program where you can earn your master's degree within one year instead of two years. You can also be qualified if you have a scientific publication or scientific presentation experience.
The next step after achieving the required education is gaining experience with hands-on training working under a senior researcher before moving up to a junior role within a team to get the skills needed for the position.
Responsibilities and duties
A clinical researcher is responsible for a variety of tasks which can be divided into the following categories:
- Regulatory duties: This includes ensuring that the clinical trial is conducted in compliance with Good Clinical Practice (GCP) guidelines, local regulations, and laws. GCP is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials that involve human subjects.
- Administrative duties: This includes preparing study protocols, obtaining regulatory approvals, maintaining patient files, tracking investigational product inventory, etc.
- Clinical duties: This includes assessing patient eligibility, enrolling patients into the trial, monitoring patients during the trial, collecting data, and reporting adverse events.
- Laboratory duties: This includes performing laboratory tests on blood and tissue samples, preparing and analyzing data, etc.
- Writing duties: This includes writing study reports, scientific papers, abstracts, regulatory submissions, etc.
What skills do you need to become a clinical researcher?
- Excellent communication skills: You will be working with many people who come from different backgrounds and workplaces. Having excellent communication skills enables you to interact with them on a professional level while building good rapport which is important for the success of the clinical trial.
- Time management skills: Clinical trials are very time-sensitive hence you need to be able to manage your time well so that you can meet deadlines without compromising quality.
- Patience and endurance: Since clinical studies often take years, patience and endurance are key to ensure that research efforts pay off in the long run while not losing focus on the objective of these studies which is the safety and efficacy of new drugs or treatments.
Do you need any extra skills?
Besides the essential skills mentioned above, some extra skills which may be beneficial for a career in clinical research include:
- Critical thinking skills: This is important to critically analyze data and make informed decisions.
- Research skills: This includes being able to design clinical trials, collect and analyze data, etc.
- Organizational skills: This helps you to manage multiple tasks simultaneously and stay on top of everything that is happening in the clinical trial.
- IT skills: This is useful in managing electronic patient records, data analysis, etc.
- Statistical skills: This is important in analyzing data and drawing meaningful conclusions from it.
How much do they make?
A clinical researcher typically earns between $40,000 and $80,000 per year. It depends on the seniority of the researcher, work experience, and qualifications.
What companies hire them?
Big pharmaceutical companies hire clinical researchers to test new drugs and treatments on human subjects for the purpose of ensuring that they are safe and effective before being used by patients. In some cases, this also includes medical devices which require testing. Some of the big names in this industry include Pfizer, Novartis, Merck & Co., GlaxoSmithKline, etc.
Some universities engage in clinical research as well with a focus on therapeutic interventions such as behavioral therapies or mind-body interventions which can be used to treat diseases without using conventional means such as medication or surgery. They may also work directly with pharmaceutical companies where they carry out pre-clinical research to establish proof of concept before human clinical trials are carried out.
How do you become a clinical researcher?
Typically one becomes a clinical researcher after obtaining a Ph.D. degree in medicine with a focus on therapeutics or a related health science discipline such as pharmacology, nursing, pharmacy, etc. Clinical experience is also necessary for those who want to pursue this career.
A postdoctoral fellowship with an established research laboratory working on the type of research that interests you can be helpful as well. In some cases simply having previous work experience may suffice if it relates closely enough to the required skills for this position which is why many people who have been practicing physicians previously turn into clinical researchers when they decide to cross over from conventional practice to medical research so they can improve their chances of getting a job.
How to apply for this position?
To find out whether a particular company or institution offers clinical research positions, you can do some basic web-based research to see if they have the facilities and resources required for conducting such research. Keep yourself informed of current affairs in medical research by reading relevant magazines and news websites on a regular basis to get a good idea of what is happening in this field.
There are many online tools that allow you to search for jobs using keywords that help narrow down the results based on your preferences. Once you have a good idea of what you are looking for, start applying for jobs that match your criteria and see where it takes you.
The interview process for a clinical research position may vary from one company to the next. However, in most cases, you can expect to be interviewed by a panel of senior researchers who will ask you questions about your qualifications, experience, and research interests. Some companies also conduct interviews with patients who have participated in clinical trials conducted by the researcher in question so that they can get an idea of how well he or she interacts with people.
Some tips on how to prepare for a clinical research interview:
- Do your homework: Make sure you are familiar with the company or institution you are interviewing with and the type of research they conduct. This will show that you are interested in the job and have done your diligence.
- Be prepared to talk about your research interests and experience: This is an important question that will give the panel an idea of what you are capable of and how you might be able to contribute to their research program.
- Have a few questions ready for the interviewers: This shows that you are interested in the job and have taken the time to think about what you want to know about the position.
- Dress professionally: This is important regardless of the industry or position you are interviewing for.
- Arrive on time: Punctuality is always appreciated and reflects positively on your work ethic.
Internship possibility
Many clinical research positions offer the opportunity for an internship. This is a great way to get a feel for the job and see if it is something you would like to pursue further. It also gives you a chance to build your network of contacts and learn from experienced professionals in the field.
Are there any certifications available?
Yes, there are certification programs that can help you get a clinical research job. Many companies prefer to hire candidates who have ACRP accreditation which stands for the Association of Clinical Research Professionals. They issue certifications after candidates have taken an exam on their knowledge of the industry and the regulations that govern it.
However, having this certification alone is not enough because most employers will prefer someone who has had a Ph.D. degree in medicine or some other health science discipline.
How do you advance your career as a clinical researcher?
To progress in this career path, one should aim to obtain as much education and research experience as possible so that they have the necessary qualifications and skills for the jobs available.
One can also consider doing a postdoctoral fellowship which is usually required for those who want to work independently or hold senior positions such as a professor or chief medical officer. Since demand is high, clinical researchers are well paid and highly regarded making it worthwhile to invest time and resources into furthering your education to become one.
Employment outlook
The employment outlook for clinical researchers is high since there is a growing need to carry out more clinical trials on new drugs and medical devices before they can be approved by the FDA so there are plenty of opportunities available at research institutions, pharmaceutical companies, and biotech firms both in the United States and abroad.
The career of a clinical researcher can be very rewarding as you are able to help improve the quality of people's lives by conducting research that can lead to new and improved treatments for various diseases. It is a demanding job, but if you have the passion for it and are willing to put in the hard work, then it can be extremely satisfying.
There are many opportunities available in this field, so do your research, apply for jobs that interest you, and see where it takes you. Good luck!
Career paths and job titles
Clinical research path:
- Clinical trial associate
- Clinical study coordinator
- Associate clinical research investigator
- Medical writer
- Research assistant and coordinator, hospital and medical practice
Nonclinical paths:
Laboratory manager/director - Under this role, you will supervise the day-to-day activities of the laboratory staff which entails training new hires as they join the team. You must ensure that people are working effectively so as to meet all project deadlines and develop new methods or processes for improving productivity. You may also be in charge of selecting lab equipment or overseeing its installation. Some tasks may include leading a team of technicians onsite at a client's facility to perform system upgrades or repairs, participating in laboratory operations audits, and writing proposals for new business.
Research scientist - As a research scientist, you will work on creating and testing hypotheses, collecting and analyzing data, preparing reports, and publishing findings in peer-reviewed journals. You may also develop new products or methods or work on improving the efficiency of existing ones. In order to advance in your career, it is important to have a Ph.D. in a relevant scientific discipline.
Scientific program manager - This position oversees all aspects of a scientific project such as budgeting, staffing, contracting with vendors, and meeting deadlines. They work with the principal investigator to make sure that the project stays on and meets the required standards. It is essential that the project manager has excellent organizational skills and be able to effectively manage people and resources. A minimum of a bachelor's degree in science is required for this position.
Quality assurance specialist - In this role, you will be responsible for ensuring that all products and processes meet quality standards. You will work with teams to develop and implement procedures and protocols, as well as review documentation. It is important to have excellent analytical skills and knowledge of GMP/ GLP regulations. A Bachelor's degree in science is usually the minimum requirement for this job