Clinical Research refers to any research carried out on humans. It focuses on improving our knowledge of diseases, developing new diagnostic methods, treatments, and medical devices for better patient care.
It is essentially a form of scientific investigation that involved human participants and helps to translate basic lab research into more defined information with a wider array of results to draw from. Clinical trials are the primary way that researchers find out if a new treatment, like a new drug or diet, or medical device, is safe and effective in humans.
Universities and colleges in Ireland are offering Mental Health Nursing courses in the following subject areas:
Many Clinical Research courses take place over 1 year to 4 years depending on the course and modules selected. There are also part-time courses and night courses available so you can be sure to fit in your studies no matter what your schedule is like.
Courses will cover all theory work through lectures, assignments, tutorials, and taught modules. Assessments will take place continuously with written examinations and practical assignments combined to achieve a qualification.
You could also consider work experience or volunteering to help with the administration of clinical research trials. Work Experience will not only allow you to obtain a deeper knowledge and understanding of the industry, but it will also give you a chance to do some essential networking with other industry professionals and gain valuable contacts for the future.
To become a clinical research associate you need to have either a degree or postgraduate qualification in life sciences, medical sciences, nursing, or any other qualification that includes subjects such as anatomy, biochemistry, biology, biomedical science, chemistry, immunology, microbiology, molecular biology, pharmacology, physiology or toxicology.
Entry without qualification is unlikely. You might occasionally be able to enter from the administration side - for example, you could start as a study-site coordinator or as a clinical trials administrator. However, you would need substantial experience and further qualifications to progress.
After completing a course in Clinical Research you will be able to get started in a career that uses specific knowledge of clinical trials and research. Clinical trials may be carried out 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 drug to monitor safety and side effects.
You'll typically be involved in all stages of the clinical trial, including identifying an investigational site and setting up, initiating, monitoring, and closing down the trial.
Working hours will depend on whether you are employed by a company with set business hours or if you are contracted to various facilities or companies. The hours are usually full-time, Monday to Friday. You should expect to work some evenings, although weekend or shift work is uncommon. Short-term contracts of six to 12 months with a company are common, meaning you may work more like a contractor than a permanent employee.
You could be field-based and will be working mainly on the road, dealing with doctors and research nurses in trial centers, GP practices, or hospitals. The remainder of your time may be spent either office-based or doing administrative work from home. Some companies have in-house, office-based CRA roles with virtually no site visit responsibilities. In these cases, the focus in this role is on document review and management. Work may be done in teams or individually.
After completing a course in Clinical Research you may choose to pursue further study in a specialist field to increase your knowledge base and skillset. Postgraduate study can also be used as a means to change career focus or to gain professional qualifications required to practice in certain career areas such as academic or pharmaceutical research, clinical data work, clinical laboratory work, medical sales, nursing, or pharmacy.
What are the responsibilities of a Clinical Researcher?
· Understand the laws that govern clinical trials in the practicing country and adhere to them.
· Take informed consent before starting the procedure.
· Explain the trial procedure to the participants in a language and tone that they will understand.
· Clear documentation of the entire procedure
· Deal with the participants legitimately and with respect
· Be a keen observer with a keen eye on details
· Monitor vitals and record all the changes that the trials undergo
· Coordinate with doctors and senior team members
What are the different types of Clinical Research?
· Pilot studies and feasibility studies
· Prevention trials
· Screening trials
· Treatment trials
· Multi-arm multi-stage (MAMS) trials
· Cohort studies
· Case-control studies
· Cross-sectional studies
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· The first physician-conducted clinical trial was in 1747. Dr. James Lind tested several scurvy treatments on crew members of the British naval ship Salisbury and discovered that lemons and oranges were the most effective in treating the condition.
· One of the first drugs to come into common use is aspirin. It is still one of the most researched drugs in the world; with an estimated 700 to 1,000 clinical trials conducted each year.
· The FDA approved the world’s first genetically engineered drug, human insulin (Humulin), in 1982.
· The word “placebo” first appeared in medical literature in the early 1800s. Hooper’s Medical Dictionary of 1811 defined it as “an epithet given to any medicine more to please than benefit the patient.” It was a mere 52 years later that a US physician planned the first clinical study with a “dummy remedy” to compare against the active treatment.
