Clinical Research Associate
A Full Guide On Becoming A CRA
A Complete Guide On How To Become A Clinical Research Associate In 2023
CRA’s are responsible for ensuring that the products coming out of laboratories like Pfizer, AstraZeneca, and Merck pass through an rigorous safety screening before they hit store shelves or hospital cabinets. CRA’s work with doctors and patients alike to ensure we always have access drugs on hand when needed – even if it means getting our hands dirty!
With the global market for CROs expected to reach $45.2 billion by 2022 and 12,000 openings available on one of America’s major recruitment platforms alone in 2021 according to BEROE4 , it is clear that clinical research professionals are in high demand5 . ACRP estimates this segment has grown 9% each year since 20153 meaning there will be even more job opportunities coming up soon!
CRAs play an important role in clinical research. They act as a link between researchers, sponsors and patients. They also help to manage communication between all three parties and make sure that everyone is working together effectively. CRAs play a vital role in ensuring the success of clinical trials.
A Clinical Research Associate is a person who helps to test new products. They work with the research sponsor or CRO, and the clinics where the product is being tested. The CRO may be a large company, a University, or a small research firm contracted to test the product in clinical trials on human participants.
Clinical research associates (CRAs) are responsible for a lot of the work that goes into clinical trials. This includes choosing and setting up locations for trials, developing and documenting protocols, creating forms and surveys for data collection, training staff to follow the protocol, and monitoring ongoing research. CRAs also need to make sure that ethical standards are being met, participant data is secure, and accurate data is being collected. They also need to coordinate across multiple research sites and communicate updates through presentations, reports, and articles.
While most people take on CRA positions for the obvious reward of positively impacting millions lives, there’s also an attractive salary to be had. Payscale estimates that median pay at $67k while other credible sources provide much higher figures with Indeed reporting a range between $72-120K!”
The Investigational Product Or IP: A Key Element Of Clinical Research
A CRA is a person who helps to move a new drug or medical device from being an idea to a product that is available for people to use. This product is called an Investigational Product, or IP. The IP might be something that prevents illness, like a vaccine. Or it might be something that helps people who are sick, like a medicine. Some IPs are created to help diagnose a medical condition. Others are created to help relieve symptoms and make patients feel better.
There is a difference between drugs and biologics. Drugs are usually made in a laboratory from synthetic (man-made) materials. They are designed to provide healthcare, including preventing or treating illness, diagnosing problems, and relieving pain. Biologics come from living organisms and are also used for healthcare purposes. They may come from plant or animal tissue—for example, a nutritional supplement could be made from seaweed. In addition to making sure that these products are safe and effective, clinical research may be done to learn more about genetics. This information could eventually help doctors predict whether someone is likely to get sick based on their genetic fingerprint. Another type of clinical research involves epidemiological studies. In these studies, large groups of people (hundreds or even thousands) are followed over time in order to study the progression of diseases or other health-related issues such as lifestyle choices and food habits.
The ICH-GCP In Clinical Research
There are two things that are important for all clinical research to have. The first is that the research respects the rights of the people being tested. This includes their freedom and dignity. The second is that data from the research process is collected accurately and stored safely.
One way to make sure these things happen is by following a set of standards for clinical research. Most countries today follow ICH-GCP, which are guidelines set by the International Committee for Harmonization of Good Clinical Practice.
Most countries today follow the ICH-GCP guidelines when conducting clinical research on human participants. The ICH-GCP outlines procedures and precautions that are essential to protect the safety and wellbeing of human research participants during clinical research, and to ensure that data from clinical research studies is accurate. In the USA, clinical studies are required to comply with the FDA Guidance for Good Clinical Practice, which is outlined in a document titled ‘E6(R2) Good Clinical Practice: Integrated Addendum to E6(R1)’.
How Does A CRA Ensure ICH-GCP (Or FDA) Compliance?
A CRA needs to make sure that the clinical research protocol meets ICH-GCP or FDA E6(R2) guidelines. They also need to make sure that the protocol is being followed by everyone on the research team.
Qualifications And Qualities Of A CRA (/CRM)
CRAs need a degree in medical or life sciences to be able do their job well to meet IAOCR standards. The New Scientist also recommends that they know subjects like anatomy, biology, biochemistry chemistry immunology pharmacology physiology toxicology so CRAs can manage data and work with EDC tools while also reporting important trends from start-to finish!
The ideal CRA has the ability to identify and correct compliance violations at a study site. The ACRP requires that they should be able not only bring such instances before site staff, but also induce them into taking corrective action as well reporting it when necessary
To illustrate this point – let’s look back over our list of abilities:
Traditional CRA Career Path
In the past, CRA positions were often filled by individuals with medical or nursing backgrounds. With little consideration given to their lack of research training. But as awareness grew about what was needed for an effective investigator assistant (i) , employers began preferring those who had years experience in clinical trials settings like CTA and/or CCPRS . This shift has been primarily due because there is now more educational opportunities available within this field than ever before which teaches new skills necessary on day-to red light green lights at work
Leading universities today offer master’s programs in clinical research. In addition, there are some widely recognized certification programs for CRAs such as those offered by CCRPS, ACRP, and SOCRA.. The leading international organization dedicated to advancing patient-centered care through education, research & advocacy is proud collaborating with us on this article about aspiring healthcare professionals who want more opportunities.
A Toe In The Door: CRA Certification For A Non-CRA
By this point, you might be wondering if becoming a Clinical Research Associate or Clinical Research Monitor is right for me. The answer to that question: it depends! You’ve got options – life sciences graduate looking at lucrative careers in pharmaceutical/biotechnological sectors; excited by research but unsure whether detail orientedness will mix well with PhD drudgery…or something else entirely?
As always-check out our course demo on how do i get started working as CRA here
With the right training, you can be recruited directly to a Clinical Research Associate position even without experience in clinical research.
Bunch of skills required for this job including being thorough and systematic while also managing people with diverse backgrounds so if any one thing doesn’t sit well then there’s probably another skill that will need improving on too!
The ACRAC is a one-of-a kind certification program that provides extensive and intense training for those without clinical research experience. This ensures candidates can be equipped with the skills necessary to work as CRAs, making it great news if you’re fresh out of college or just starting your career!
Training To Be A CRA Through The SCRP Program
The SCRP-CCRA program is a comprehensive 250-hour training course that can be completed at your own pace or, for those who are able to dedicate the whole day of study, in as little two weeks. The curriculum covers all important knowledge domains and skill sets required by CRA’s including; GCP principles & terminology related specifically towards clinical research plus ICH&GPA regulations found within FDA guidelines known retrievably via E6(R2).
Students who want the CRA certification learn about designing Clinical Trial Protocols. This includes learning about the CFR. They also learn steps involved in getting IRB/IEC approvals and how to prepare required documents. Students also become aware of pharmacovigilance and new drug testing regulatory processes.
A big part of the SCRP-CRA certification is about teaching the CRA how to do their job on a day-to-day basis. This includes different types of visits to sites, like preliminary visits (to check if the site is qualified), preparatory visits (to get ready for the trial) and progress monitoring visits (to make sure things are going well). The SCRP-CRA also covers important paperwork, like the Case Report Form and Trial Master File. Plus, it covers electronic data capture (EDC) and remote monitoring systems.
The training program is important because it helps students learn how to handle difficult situations. For a CRA, this includes being able to identify when there are problems with a research study, and reporting it if necessary. The SCRP-CRA certification also offers other advantages, like 17.5 CME credits. This means that the course can be used towards continuing medical education for people who want to further their careers in healthcare fields such as medicine, nursing, pharmacy or research.
Successful CRAs Share Experiences And Insights
What are some things that you can do to make sure that you are successful as a CRA? How can you make sure that recruiters take notice of you? We asked some senior CRAs to share their experiences and advice on what helped them get their jobs. Here is some of the advice they gave:
1. Know Your Stuff
It is important to learn as much as you can when you are looking for a job in clinical research. Many of the people who were interviewed for this study said that they read everything they could find on the topic, and they also took detailed notes. This is the best way to remember what you need to know!
2. Volunteer Your Time and Skill
Many experienced CRAs (clinical research associates) recommend doing free work, or volunteering, especially when first starting out. By working for free, you’re actually investing in your career. This is because people can try you out without taking any risks. They can see how passionate you are, how well you work, and if you’re punctual. If they like what they see, they’ll remember you when a good opportunity comes along.
3. It Pays to Persevere
The third recommendation is to keep trying and not give up. Being offered a CRA position on your first or second (or tenth!) application is rare. Some CRAs in our poll had applied to as many as a hundred different places before they were offered a position! Don’t let this discourage you. Use your network, and the free resources on the internet to look up clinical research openings. A great free resource that provides an extensive list of all clinical research trials being run in the USA can be found at clinicaltrials.gov
4. Be Adaptable, Show Initiative
It is important to be adaptable and show initiative if you want to be a Clinical Research Associate (CRA). Several experienced CRAs shared how they started out by being helpful at clinical sites. This can include finding patients, doing paperwork, and helping existing coordinators run trials. Basically, they did anything and everything they could to show the clinical team that they were serious about the job. One CRA explained how she tries to communicate this to aspiring CRAs. People sometimes think that recruiting patients is not part of a CRA’s role – but it doesn’t matter. What matters is that you’ll be coming to the clinical site as someone who can add value to the team.
Continuous Growth: Taking the CRA Career Further
If you’re thinking about becoming a CRA, you’re on the right track! Becoming a CRA is just the first step in a long and rewarding career. Many CRAs move up to Senior CRA positions in less than five years, and some even go on to lead CRA teams or take up senior corporate positions. So keep up the good work and you’ll be on your way to a great career in no time!
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