Clinical Trial Research Aimed at Assessing Behavioral, Surgical, and Medical Intervention
Clinical trials research are studies that are carried out on people. They are usually aimed at the evaluation of behavioral, surgical, and medical intervention. For example, there are different ways that researchers apply clinical research to discover something new about a medical device, diet, or even drugs. Others aim at identifying diseases as early even before any symptoms are evident. They are used to find ways in which health problems can be prevented. Additionally, clinical trials may also be conducted to find ways in which life can be better for persons who are living with diseases that are life-threatening or people with chronic health issues.
What is done before approval?
Before any clinical trial research is approved, laboratory tests have to be conducted by qualified scientists.
Studies are first done on animals subjects. This is done to test the therapy’s potential efficacy and safety. If favorable results are achieved, then the necessary regulatory body can give approval for it to be tested on human subjects.
The phases
The advancement of clinical trials research covers different phases to understand the dosage and identify side effects. When these four phases are complete and the drug or device is seen as favorable, then it receives approval for mass use. However, researchers will continue monitoring the product even after it is introduced in the market.
During phase one, tests are done on healthy people, but in a small group to find the correct dosage, and side effects.
The second phase involves more people and this time the aim is to find the treatment or device’s effectiveness. It offers data on whether a condition or disease can be combated by the drug.
The third phase is about effectiveness and safety. Different dosages and different populations are tested. The drug can be combined with others to see how that impacts the body. This is the point where the product gets FDA approval.
In phase four, after approval, the safety, and effectiveness of the device or drug are tested on a more diverse population for long term effects and monitored after it goes on the market.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
CNR: What Should Clinical Research Nursing Students be Reading
As an aspiring clinical research professional, it is important to stay up to date with what is happening in your field. Clinical Nursing Research (CNR) is a journal that covers clinical nursing. It is released four times a year and addresses clinical issues meaningful to nursing students. It also opens an international forum provide room to:
Spread widely findings of a particular research to practicing nurses.
Improve clinical practice by identifying clinical application that conforms to the latest research.
Encourage clinical practitioners among themselves.
CNR is one of the most important resources for clinicians and researchers who are concerned with improving their work. In addition, CNR provides graduates and undergraduates in the field of clinical nursing research with a source of field insights that will impress future employers and coworkers.
Features involved
Clinical nursing research offers some articles and features such as:
Feature articles with international references: this will enhance your understanding of the full scope of international research.
Articles researched: This involves discussions on a research project’s findings
Brief your research: short research reports on specific aspects of practice.
Replicated studies: These studies compare new findings with the existing ones, thereby providing important information to clinicians. This forms the basis for introduction of findings.
Who does the research?
CNR is written by a clinical nurse specialist. Their aim is to increase the standard of patient care. They also focus on finding a new treatment for different diseases. The nurses make sure that the patients are well protected and well supported during the period of study.
At CCRPS, in addition to ACCRE-certified courses, we also offer in-depth guide on how you can succeed in the clinical research field. Check below to sample some of our nursing articles.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
Clinical Cancer Research and Areas That Hold Interest
Clinical Cancer Research is a peer-reviewed medical journal based on oncology. It includes therapy, diagnosis, prevention, molecular and cellular characterization of human cancer. It also covers topics like clinical generics, surgical oncology, pathology, pediatric oncology, radiation therapy, and hematological oncology.
What it entails
The publication elaborates on the application of different disciplines of molecular, cell biology, and immunology genetics in the integration of cancer in humans. The main areas of interest are the clinical trials, which evaluate of the new treatments available to predict resistance and response.
Animal and laboratory studies of molecule targeted agents and drugs that have potential too. It focuses on studies of metastatic disease, malignant phenotype progression, and oncogenesis of targetable mechanisms.
The journal issues and what they cover
Clinical Cancer Research has been in publication since 1995. Publications have been submitted by all sorts of investigators, who represent disciplines like clinical and laboratory all over the world. Countless translational and innovative clinical cancer studies have been published in order to bridge clinic and laboratory. This is a journal that holds interest in the clinical trials that evaluate any new treatment. This is especially true when it comes to pharmacology research and molecular alterations.
Other interest areas include:
Human tumors molecular characterization
Radiation and radiobiology oncology
Gene therapy
Clinical and immunotherapy immunology
Application of biostatistics and bioinformatics personalized medicine
Pharmacogenomics and pharmacogenetics
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
Different Categories of Clinical Research Jobs Available as Careers
Clinical research helps cure all sorts of conditions and diseases. If a clinical trial is to be successful, there are a lot of things that need to be considered. This means that there are different career paths that one can choose to pursue in this area.
Contrary to popular belief, you don’t have to work in a lab if you want to work in clinical research. If you are interested in clinical research, chances are, there will be a job that suits you.
Clinical research jobs
Some of the most popular clinical research jobs available today include:
Trial monitor, clinical monitor, field monitor, or clinical research associate (CRA)
This is a professional responsible for supervision and monitoring the clinical trials being administered. CRAs are often hired by sponsors of the trials being conducted. Their duties include case report reviews, data filing, and investigation on the accountability of products and so on.
Clinical research coordinator (CRC), site managers, or research nurses
These professionals direct the clinical trials together with the principal investigators by applying best clinical practices. They can enroll and screen patients.
These are the system architects for the production of data. A lot of data is involved in trials, so the manager has to be analytical, strategic, and incredibly thorough.
They conduct trials that require more experience and technique. They need a PhD or MD before they can practice. Traveling is often needed for this position.
Other jobs include:
Biostatistician
CQA or clinical quality assurance auditor
CSA or clinical safety analyst
Medical writer
Research assistant
Regulatory coordinator
Senior regulatory associate
Regulatory scientist
CTMS manager or clinical trial management system manager
Clinical trial management system associate
Senior business development associate
Business development assistant
Senior QA specialist
QA specialist
Patient recruitment manager
Patient recruitment specialist
Administrator of the clinical systems info
Senior clinical research associate
There are endless opportunities in clinical research and so you can pick according to qualification or
interest. If you want to learn more, visit CCRPS.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
The Job Description of a Clinical Research Associate
Clinical research associates are also referred to as CRAs. They are responsible for organizing and administering clinical trials of a current or new drug to assess and determine the risks and the benefits associated with using them. Clinical research associates are often employed by clinical contract agencies and pharmaceutical companies. There are many things that a clinical research associate needs to handle, and we will discuss them in this article.
Their responsibilities
The key responsibilities that a clinical research associate has to carry out in their course of duty include:
Writing reports
Progress monitoring during the trial duration
Collection and authentication of forms that are used for data collection
Giving the clinicians instructions about how trials are to be conducted
Designing different trial materials as well as providing different study centers that have sufficient quantities
Setting up the trial centers and then disbanding them
Identifying the clinicians and briefing them
Writing down the procedures of the drug trials
The employers
Typical employers include:
The academic departments in hospitals
Clinical contract houses and agencies (CROs)
Pharmaceutical companies
Available vacancies are usually advertised in the national newspapers, online, specialist agencies, and very specific journals. This field is very competitive, therefore it can be useful for applicants to have the relevant analytical and scientific techniques. In addition, pharmaceutical research, medical sales, nursing, or laboratory work knowledge can be very useful in clinical research associate positions.
The process of recruitment involves an interview, which is very technical. You will need to be trained to get the kind of qualifications that are necessary to excel in this area. To achieve this, you need to be qualified in life sciences or medical sciences. To learn more about clinical research professional courses, visit CCRPS.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
Understanding the Scope of Clinical Research and What it Entails
Clinical research can be defined as a study of illness and health in humans. This is how we find out ways in which we can prevent, make a diagnosis, and even treat illnesses. Usually, the focus is on the improvement of knowledge and coming up with the best diagnostic methods or new treatments to create better care.
Clinical research respects a study protocol that is very precise and organized. A clinical research can only be fully realized under specific conditions.
The research must:
Collect the necessary consent from all participants of the research
Obtain all the approvals as required by the law and ensure all the ethical steps are adhered to
Take the necessary measures to protect everyone who joins in the research
Be conducted by people who are competent
Have the aim of growing medical knowledge
Types of clinical research
There are two types of clinical research that can be conducted:
1. Observational studies (epidemiology, cohort study)
2. Clinical trials or Intervention studies
1. Observational studies
This kind of research is aimed at the improvement of knowledge of a particular disease as well as how it has evolved over a period of time. Usually, they are conducted within a set framework where patients have follow ups in reference centers. Historical studies are also included here.
2. Clinical trials or Intervention studies
These aim at providing enough scientific evidence of the safety and effectiveness of new drugs, new illness management, or new care device. This is a step which is necessary before any molecule can be made a drug as well as a new medical device before it is brought to the market.
There are very strict steps that are involved in this case and they include:
Administration to healthy humans
Administration in the patients
Therapeutic efficacy
Marketing authorization or approval
Evaluation and monitoring of the side effects
Clinical trials
Clinical trials fall under the clinical research umbrella. It is an experiment which is designed to address very specific questions regarding possible treatments or any new ways that can be used with existing treatments. They are done to determine if the treatments and new drugs are effective and safe. Clinical trials are usually a long and careful process that can take years before completion. The treatment has to be studied in a lab by qualified doctors.
Drugs and treatments need to be animal tested before any human testing.
Medical care and clinical research
It is common for people to confuse medical care and clinical research. In Medicare, a patient has a plan that is unique to their needs. The treatment plans have already been tested and proven safe and effective.
Everyone who wants to undertake clinical trials should be aware that it is an experiment. This means that while patients will have access to the newest technology, clinical trial may or may not benefit you.
In clinical research, there is usually a pre-determined set plan or protocol that the researcher and the subject have to follow. In a clinical trial, there are steps taken if someone starts feeling unwell during the trials, but the researcher is not allowed to make any adjustments to the plan to fit any particular subject. It is therefore important to have everything laid out with the researcher and your doctor.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
What is Icon Clinical Research and What Do They Do?
Icon Clinical Research is an organization that offers a wide range of commercialization, development, and consulting services from a network, which operates globally with offices in thirty seven countries. The organization was founded in Dublin, Ireland back in 1990 and had the mission to assist clients to fast track drug development as well as devices aimed at saving and improving lives. This is achieved by the deliverance of the highest class of information, performance, and solutions. The most important thing at Icon is providing the highest quality standards all the time.
Focus
Icon focuses their innovations in different areas, especially the ones important to the clients. Some of these factors include reducing time taken to market the products, reducing the costs of production, and increasing the quality of the products. The organization has a team of experts operating at a global level with the kind of experience required to deal with different therapeutic areas. One of the most important things for the organization is quality. They aim at providing and even exceeding the quality standards expected by their clients.
The leadership team has got professionals who have the most extensive experience in the industry. They have employed over 13,000 people all over the world.They also run operations and have experience in the localities, which are important to different types of clinical research.
Commercial, consulting, and clinical services
Icon is able to offer a wide range of services which are specialized to help medical device, biotechnology, and pharmaceutical companies bring new devices and drugs into the market even faster. Their services usually span the whole product development life cycle. Their expertise suit the local trials as well as global programs. Check out their website here.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
Answering Common Clinical Research Questions
Not many people know anything about clinical research; what it means, the purpose of clinical research etc. There are certain clinical research questions that are asked frequently. They need to be answered to give people assurance on what clinical research is really all about. Understanding these basic questions will help people make the right decisions concerning clinical research.
What does clinical research mean?
Clinical research are studies carried out to with the aim of improve human health and health care service in general. It seeks to answer difficult health questions, like how a sickness is contacted and spread, how to cure a sickness, and how to create new treatment methods.
Who can participate as research subjects?
Anyone can, as long as they are aware of the risks. A great way to find studies is visiting NIH clinical trials.
There are guidelines to choosing the people that can participate in a research as clinical research volunteers. These guidelines are called the “inclusion criteria” or the “eligibility criteria”. These criteria are based on factors such as gender, age, medical history, medical conditions, type of disease and stage of the disease etc. before a person can participate, they must have met the requirements to participate.
What are the benefits that a person can get from participating in a clinical research?
There are various benefits that a subject can get from volunteering as a participant. They are:
They get to play important roles and make important decisions that pertains to their health.
They have access to new treatments that are not yet available to the general public.
They have access to expert care during the trials for free.
They make valuable contributions to the area of medical science without necessarily being medical experts.
Some clinical researches offer monetary benefits, reduced treatment cost or even free medical care to the participants to serve as incentives.
How can I get comprehensive clinical research training?
This question is usually asked by those who have developed interest in the area of clinical research and might want to start a clinical research career. There are quite a lot of avenues through which you can get the required training. But the best place where you can take the right clinical research training courses is at ccrps.org. Receive education and knowledge from experts in the industry and succeed in your chosen career.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
Where are Clinical Research CROs Growing?
The field of clinical research is one that has become very important. More than ever before, there are CROs (clinical research organizations) popping up everywhere in the world.
CROs are responsible for supporting pharmaceutical companies, medical device industries, biotechnology companies, government institutions, and so on with outsourced research services. The presence of CROs all over the world has made it possible to conduct more clinical trials at one time. In addition, they have helped increase the success rate of clinical trials by providing the clinical researchers with information that are necessary for their own subsequent researches to be successful.
The presence of CROs in USA have helped to improve the quality of healthcare service in the country and in the world at large. No matter where you live in USA, there are a lot of clinical researches going on around you and there are more clinical research organizations in Los Angeles, Chicago, new York, Philadelphia etc.
It is important to state clearly that the United States of America is not the only country that conduct clinical research, and thus it not the only place where it thrives. There are different clinical research centers all over the world.
In the United Kingdom, the field of clinical research has become very important. UK clinical research also has a lot of opportunities for aspiring clinical researchers.
Other countries like India also have a strong clinical research presence and although it is a competitive field, it’s not so difficult to get clinical research jobs in India.
Everywhere you go in the world, there are a plethora of clinical researches going on in different cities and locations all over the world. Clinical research is closer to you than you think.
If you’ll like to find out more about clinical research, check ccrps.org for access to the best clinical research consultation.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
Clinical Research Associate Job Description
Read more about the Clinical Research Associate Jobs descriptions and skills that require in Clinical Research Associate post. Visit us now!
Clinical research associates (CRAs) are responsible for organizing and administering clinical research trials for new or current drugs so that they may assess the risks and benefits of using them. The major responsibilities of clinical research associate jobs are:
They write out the procedures for administering drug trials.
They identify and brief appropriate trial investigators.
They make use of their knowledge of the basics of clinical research to collect and analyze and record data.
They design trail materials and supply the research study centers with the quantities that they need.
They monitor the process of the trial from the start to the finish.
Clinical research associates are always present in the institute of clinical research because of the essential duties that they perform. However, the position is very competitive according to various job websites. As competitive as it is, it is also lucrative. Clinical research associate can work in government clinical research institute, pharmaceutical companies, private owned clinical research institute, etc. Their salaries may differ based on how much the individual companies or employees offer at their different choice of work place. But on the average, clinical research associates are paid around $65,000 per year. This leaves the pay at about $24 - $25 per hour.
There are various factors that can affect how much a clinical research associate (CRA) goes home with at the end of the month or cumulatively at the end of the year. These factors can be the location of the company, that is, the economic strength of the country or city where they are working, the degree or certificate or the level of education and exposure that the CRA has, the number of years if working experience that they have accumulated. These factors work together to determine how much they take home.
You can boost your chances of getting a higher pay, in the region of $85,000 to $90,000 or even more by getting the necessary education and certification. For example, experienced contract CRAs can earn up to $300k.
Skills required to be successful as a clinical research associates include:
A logical and inquisitive mindset with quick thinking.
Good organizational abilities.
Excellent communication skills. Both written and verbal are important.
Commercial awareness.
Confidence
The basic requirement to be a clinical research associate is an undergraduate degree or a postgraduate degree in related life sciences fields (like biology, toxicology, microbiology, pharmacology, biochemistry), nursing, or medical sciences (like immunology, pharmacy, anatomy, physiology, or medicine). Due to the competitive nature of the job, some people go ahead and obtain a doctorate degree in any of the above mentioned fields. This gives them a better chance of getting a senior level job and increase their promotion prospect.
Beyond academic degrees, you need to be certified to become a clinical research associate. You need certification from organizations like ACRP (association of clinical research professionals) or SOCRA (society of clinical research associates). You will need to obtain certification course and pass the exams to become certified. At ccrps.org, we offer ACCRE accredited courses and insider information on everything you need to know for a career in clinical research. You can click here to see the offers for the courses available.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
Clinical Research Opportunities in New York City
Clinical research in New York has been on the rise in recent years. New York City is known for its advancement in clinical research and management.
Participating in a clinical research in New York is beneficial to the participants and it is a way for you as the participant to help people with such health issues and also contribute to the medical sciences. Popular benefits include:
Getting free medical care.
Being involved actively.
It helps you to improve your lifestyle for better health.
You have access to and benefit from new treatments that are not yet available for the general public.
Clinical research in US have been ongoing for a long time. With every discovery and advancement, it becomes more important part of healthcare. If you are interested in being a clinical researcher in US, you can get all the help that you will need to be successful at CCRPS. From knowledge to experience to degree and certification, you will get all the needed help from experts and professionals in the clinical research industry that are willing and ready to set you on the right path.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
Clinical Research Field Knowledge Everyone Should Know
What is Clinical Research?
Clinical research is a branch under healthcare sciences that is responsible for finding out the effectiveness and safety of medical devices, medications, diagnostic products and treatment regimens that are intended for human use in the cure of diseases and illnesses.
Clinical research is used for the diagnosis, prevention, treatment, relieving or alleviating of symptoms of a disease, and is much different from clinical practice. The major difference between clinical practice and clinical research is this - clinical practice works with only established treatments, while clinical research works to make a new established treatment.
Clinical research spans from inception tests to introduction to the consumer market. It goes through stages of tests called phases. It is done with the main purpose of testing the effectiveness and safety of a drug for human use.
Bodies Concerned With Clinical Research
Europe
In the European countries, the European Medicines Agency (EMA) is the regulatory body that facilitates clinical research studies. Human subjects that have given their informed consent are allowed to participate as research subjects in the 4 phases of clinical research.
United States
In the United States, the conduction of clinical research is a little more complex.
A new drug or treatment that has not yet been approved or cleared by the Food and Drug Administration (FDA) cannot be given a license. Clinical research data has to be submitted to the FDA through the support of an (IND) Investigational New Drug application. This enables the FDA to review the new treatment before they are used to conduct studies involving human subjects. After all proper investigations by the FDA, the new drug or treatment can now be licensed and advertised.
In the case of medical devices, if the device shows signs of significant risk or has not been exempted or licensed by the FDA, then the clinical research data has to be submitted to the FDA through the support of an (IDE) Investigational Device Exemption application. This process may also require approval from any of the following; Institutional committee reviews, Radiation Safety Committee, Conflict of Interest Committee, Privacy Board, Radioactive Drug Research Committee, Research Ethics Board (REB) or the Institutional Review Board (IRB).
Criteria for Review
The criteria for the review of all clinical research depends on the following;
• Federal regulations that the research falls under and is subjected to.
• The regulations the institutions subscribe to.
• The response to local, state, federal laws, policies, rules, regulations, or accreditation entity recommendations.
The last criteria for review is supervised by the IRB or ERB in concordance with the regulatory affairs to protect human subjects.
Where Do Clinical Researches Take Place?
Clinical researches usually take place at affiliated research study sites, hospitals, healthcare clinics, or academic medical centers. These places are strategically placed to provide the competence of the academic institutions involved as well as provide closeness to the medical participants pool.
The ethical issues and conducts of clinical research is overseeing and supervised by their internal institutional review boards.
There are lots of professionals involved in the world of clinical research, as it is a complex network of pharmaceutical companies, academic research institutions, and biotechnology companies. All these has led to the fast growth of technologies used in the operational factors and management aspects of clinical research.
The operational factors are overseen by clinical research professionals such as, CRAs, CTAs, CRCs, and others, while the management aspects of clinical research are overseen by CTMs, CRMs, CRPMs, CrDMs, and others.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
How To Maximize Using The Clinical Research Wiki
One way you can be sure to get answers to all of your clinical research questions is going through the clinical research wiki. All clinical research information that pertains to important issues such as the different fields of clinical research, the roles and functions of all the different clinical research professions, how to work in clinical research are available on this site.
For example, let’s say you want to know how to define clinical research. According to the wiki, clinical research is defined as a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use.
With this definition from wiki, it is easy to see why clinical research is very important to medical science and the healthcare system. However, it is important to know that because the wiki can be changed and altered, it is important to double check any information by looking at the source material sited at the bottom of the page.
Once you know how to utilize a search engine like the clinical research wiki, you can learn so much about the various aspects of the field. This is especially important if you are looking to start out a career in clinical research.
Whether you are starting out as a clinical research assistant, a clinical research associate, or a clinical research coordinator; all of them have basic requirements that you need to meet. It could be a degree or passing certification. Chances are, you will need help passing the certificate examinations conducted by the Association of Clinical Research Professionals. That is where CCRPS comes in. CCRPS provides quality clinical research programs and will equip you with all you need to have a successful career.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
How to Get into Clinical Research Step by Step
Looking for clinical research jobs? Visit CCRPS at here you can get the all information about clinical research remote jobs. Apply now!
What is Clinical Research?
Clinical research is a branch under the healthcare sciences that is responsible for finding out the effectiveness and safety of medical devices, medications, diagnostic products and treatment regimens that are intended for human use to help cure illnesses. Clinical research is important for the diagnosis, prevention, treatment, alleviating of symptoms of a disease, but it is much different from clinical practice.
You want to get a career for yourself in clinical research, then let's take you through the drill.
The first step is to get an education.
Earn a bachelor's degree in a life science or health related discipline. Courses like medicine, pharmacology, biology, molecular biology, genetics, anatomy, biotechnology, nursing, physiology, chemistry, or bioengineering will equip you with the necessary and relevant knowledge to get you into clinical research.
Supplement your education by applying for the courses offered at your university or from professional organizations like Certified Clinical Research Professionals (CCRPS) and Association of Clinical Research Professionals (ACRP). These courses will include; study designs, Good Clinical Practices (GCP), research ethics, drug development cycle, regulatory affairs and requirements both in the US and internationally, among others.
Get a certification from a reputable organization, such as CCRPS, ACRPS, and Society of Clinical Research Associates (SOCRA).
Make sure you study the ICH GCP guidelines and ethics to make you competent. Training in the International Conference on Harmonisation (ICH) Good Clinical Practices (GCP) ethics and guidelines improves your chances greatly. At CCRPS, we offer a free ICH GCP certification to help you get started.
Keep proper documented records of your certifications as well as your education.This will save you a lot of time and stress.
The next step is to gather experience.
The following are ways you can gather experience:
Volunteer - Look for volunteering opportunities around your area and volunteer to help with the projects that will be carried out in the clinical research industry. This helps you get closer to the professionals as well as the tasks itself. You can volunteer at clinical research professionals organizations related to the clinical research field or medical field, medical centers or hospitals, International Review Boards (IRB) or Research Ethics Committees.
Research Projects - Take up clinical research monitoring projects and you can gain at least two years of experience.
Internships - Seek out an internship with medical firms, biotechnology companies, and pharmaceutical companies while you're still in college. CCRPS offers an internship program that can help you develop your resume.
The next step after getting an education and gathering experience is to apply for entry-level positions
A job as a clinical research professional is a rewarding career, and as such you must not only get an education and experience, but you must also be able to put in a high quality CV and cover letter for your application.
As long as you have a bachelor's degree and at least one year of experience in clinical research, you can easily qualify for an entry level position in clinical research. A quick search for “clinical research jobs near me” allows you gain more insight into the clinical research industry.
So, how do you get a job?
Here are tips that you need to keep in mind when you are applying for clinical research jobs.
• Be realistic about the jobs you can go into with your educational background and experience. Apply for entry-level positions firsts, then work your way to the top with targeted efforts and tenacity.
• Read each job descriptions clearly and highlight on your CV the relevant experience that you have that matches the specific role requirements. That little edit can change the way clinical research recruiters and consultants look at your CV as compared to others.
• Network with hiring managers and clinical research recruiters to expand your base as not all companies will advertise their vacancies. Upload your CV to a database that enables employers, clinical research recruiters, and hiring managers to easily find you.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
Clinical Research Coordinator Jobs
Looking for clinical research coordinator jobs? Visit CCRPS and check out the recent job post descriptions and skills required for CRC.
Clinical research coordinators have a responsibility to administer clinical trials. Their duty apart from this also include collecting data, giving out questionnaires and informing study participants about the aims and objectives of the study.
Their overall duty are as follow:
They oversee the smooth running of clinical trials in the clinical research facility
They collect, code and analyze data gotten from the research.
They manage the research budget.
They carefully monitor the clinical trials to endure that they comply with moral, ethical and regulator standards.
They are actively involved in the recruitment of subjects for the trials.
They make sure that needed supplies and equipment are available and ready for use.
As a clinical research professional, clinical research coordinators work with and directly under the clinical research project manager. The work of the CRC is actually a very important one in any clinical research institute. There are many clinical research job websites that have laid down requirements for the post of the clinical research coordinator. These requirements could include:
An associate degree in nursing or any other related fields.
Should have at least 2 years experience in healthcare.
Very good interpersonal skill.
An ability to communicate effectively in both written and oral modes.
Must have an analytical mindset and excellent organizational skills.
Must be ready to learn and self-educate while at the job.
The clinical research coordinators understand the basics of clinical research and are expected to put this knowledge into play when organizing their team of clinical research associates and the research lab as well.
Much has been said about the work of a clinical research coordinator but no one becomes a CRC in a day. There are degrees, academic requirements certificates that you must possess before you can become or offer a job as a clinical research coordinator. You will need certification from the ACRP (Association of Clinical Research Professionals) or SOCRA (Society Of Clinical Research Associates). Getting the required certificate will mean that you have fulfilled the eligibility and have passed the necessary examinations. This can be quite a task, but at ccrps.org, we make passing the examinations and getting the certificates easier for you. You can register for our available courses and get the help needed to take your clinical research coordinator career to the next level.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
Clinical Research Project Manager
Clinical Research Project Manager - A Full Guide To Becoming a Clinical Trial Project Manager
As of mid-April 2022, top recruitment platform ‘indeed.com’ lists 6,026 openings for Clinical Research Project Managers across the United States[1]. According to ‘payscale.com’, remuneration for this profile ranges from $84,168 for early-career to $120,501 for experienced Clinical Research Project Managers, with a mid-career median of $107,649[2].
A Clinical Research Project Manager (henceforth CRPM) is also known as a Clinical Research Manager or a Clinical Trial Manager. The role of a CRPM is to provide leadership during the clinical trial of new drugs, with the overarching goal of ensuring that the clinical trials process is completed within the stipulated time-frame and allocated budget, while maintaining the highest standards of research quality and scientific integrity.
An overview of the CRPM profile
A Clinical Research Project Manager is the liaison between the study sponsor and the clinical research team. Thus, the CRPM must balance the expectations of the funding organization in a clinical research study (pharmaceutical company, governmental agency, university research division or other entity) with the needs of the team, including Principal Investigators (PIs) and co-PIs, Clinical Research Coordinators (CRCs), Clinical Research Associates (CRAs), Clinical Trial Assistants (CTAs) and other site staff.
The CRPM plays a leading role in planning, implementation and ongoing monitoring of live clinical trials. In the process, a CRPM also mentors junior team members, including CRAs and CTAs.
Evidently, a career as a CRPM is rewarding, but also demanding. So, what does it take to qualify and be recruited as a Clinical Research Project Manager?
The road-map to becoming a CRPM
Even if you’re new to the field of clinical research, you’ve probably guessed by now that becoming a Clinical Research Project Manager takes both qualifications and experience. A typical CRPM has a bachelor’s (or master’s) degree in life science, combined with four to five years’ experience in one or more clinical research roles such as CRC, senior CRA or QPPV (Qualified Professional in Pharmacovigilance).
Irrespective of where you are along this path, the remainder of this article charts a clinical research professional’s journey of growth in developing into a competent CRPM. For conceptual convenience, the process is discussed in two parts – Part 1 centers on the research and administrative skills needed for a CRPM, while Part 2 revolves around expertise in project management. The final sections address how the Advanced Clinical Research Project Manager Certification or ACRPMC facilitates the transition to a CRPM role.
The CRPM journey, Part 1: Research and administrative skills
By the time a clinical research professional is eligible to apply for a CRPM position, s/he has typically developed a range of competencies in the day-to-day running of clinical trials. In addition, a professional at this stage has usually acquired a good working knowledge of the planning and oversight required for a clinical research study.
In broad strokes, a CRPM candidate likely already has a knowledge base and skill sets in the following areas:
1. ICH-GCP guidelines, Title 21 of FDA CFR and IRB compliance
One of the first things every clinical research professional learns is the importance of adhering to the principles and policies of good clinical practice, as outlined in the ICH-GCP[3]—these guidelines set the framework for carrying out research in a manner that prioritizes the safety and welfare of human subjects and the quality and integrity of clinical data.
The ICH-GCP principles are mirrored by Title 21 within the US FDA’s Code of Federal Regulations (CFR)[4]. Clinical research across the US must conform to the requirements of Title 21. Part of Title 21 regulatory compliance requires nearly all clinical research studies to first be approved by an Institutional Review Board or IRB (also called an Ethics Committee). As clinical trials progress, any changes to the study trial protocol, consent procedures or data management system must likewise first be reviewed and approved by the IRB.
The CRPM has final responsibility for ensuring that all documentation necessary for clinical research regulatory compliance is maintained and updated as needed.
2. Clinical trial design concepts and parameters
A sound grasp of the clinical trials process is similarly a must for senior professionals in the team. Candidates for CRPM positions are thus expected to have a thorough understanding of key concepts and procedures relating to clinical research, including:
Phases 1 to 4 of clinical trials[5]
Investigational products (IPs) including INDs and IDEs
Design concepts in clinical trials - control, randomization and blinding
Subject screening and selection, retention and study compliance
Trial data input, quality assurance, analyses and reporting
Adverse Event (AE) documentation and reporting
3. Pre-trial preparation
In some ways, the most crucial phase of a clinical trial is the preliminary or preparatory phase, during which all groundwork must be laid for the smooth and efficient conduct of the actual study. This phase must typically achieve the following objectives:
Complete documentation for initiating clinical trials[6] – An IRB-approved clinical trial must have in place a host of documents covering important aspects of the study, including the investigator brochure (IB), trial master file (TMF), informed consent form, case report form (CRF), subject recruitment notice, laboratory protocol, study financial projections and so on.
Identification and preparation of study site(s) – Most clinical research studies are run across multiple sites, which may be hospitals, clinics or other health-care facilities. Identifying suitable sites, establishing collaborative agreements with site administrators, as well as setting up the required infrastructure to carry out trials at each site is crucial in preparing for a clinical research study.
Pre-trial publicity – The success of clinical trials depends on gathering large amounts of data from human subjects. Therefore, creating public awareness and interest right from the outset is critical to running clinical research studies effectively.
When setting up a study, the CRPM plays a central role in initiating and fulfilling each of the goals outlined above. Under the CRPM’s guidance, clinical research administrative staff including CRCs and CRAs work to put relevant documentation in place, prepare study sites and create public awareness about the study.
4. Active trial administration
The day-to-day running of an active clinical trial involves numerous administrative components, including:
hiring and training staff at clinical sites
tracking subject recruitment and retention
regulatory compliance in trial protocol, subject safety and data quality
Adverse Event (AE) documentation and reporting
oversight of trial drug storage and use
coordination among research teams across sites
tracking study finances
communication between study sponsors and clinical staff
electronic data capture (EDC) and management
timely renewal of necessary financial and regulatory approvals
These tasks are distributed among members of the investigative teams (PIs, co-PIs and other medical personnel) as well as administrative teams (CRAs, CRCs, QPPVs and other site staff). However, the CRPM is ultimately responsible for ensuring efficient administration that keeps the clinical trial on track.
5. Study termination procedures
Winding up a clinical trial similarly entails a number of administrative exercises. Here again, the CRPM must oversee execution, guiding team members in completing tasks on schedule and to the required standard:
site close-out (relieving staff, subject debriefing, equipment surrender)
final data consolidation and scrutiny
study completion documents for regulatory compliance
compilation of briefs and reports for regulatory authorities, study sponsors
The CRPM journey, Part 2: Expertise in project management[7]
Most aspirants to CRPM positions have usually been engaged in the clinical research process for at least a few years. Many have played administrative roles, working as CRCs, senior CRAs, QPPVs or site managers. In some cases, CRPM aspirants have clinical backgrounds, with expertise in drug research or medical monitoring.
Despite their hands-on experience with the clinical trials process, professionals wishing to transition to CRPM roles usually have limited exposure to the higher-level project management knowhow that is essential for an effective CRPM. This section provides a brief overview of the major project management domains relevant to clinical trial management:
1. Project and operations planning
A clinical trial is a major operation, involving a range of geographical and health-care settings, multi-disciplinary teams, as well as a complex array of regulatory and logistical requirements. Planning the stages, milestones and operations of a clinical trial is integral to assuring its success. Therefore, project and operations planning are the top priorities of a CRPM.
Some of the key elements involved in planning a clinical trial include:
Compiling a comprehensive study protocol describing the rationale, aims, design and methodology, data analysis plans, and trial procedure (/protocol)
Setting project goals, deliverables and milestones
Outlining a project personnel schematic that delineates team and sub-team structure and defines individual team member roles
Generating a responsibility blueprint with a clear break-up of tasks, targets and time-lines for each project goal and each team member
Creating a communication plan that outlines the method and schedule for relaying information, updates and requests between and within teams
2. Financial forecasting and tracking
One of the biggest challenges confronting a CRPM is keeping the trial within budget, while making sure that resources are optimally allocated to cover all necessary project-related expenses. Clinical trials often suffer from scope creep, that is, the inclusion of additional goals and deliverables to those originally outlined, resulting in the project overshooting budget and time-line.
It is therefore recommended practice for a CRPM to work with study sponsors and senior team members in compiling a budget management plan at the very outset of the project. Such a plan not only specifies financial outlay for each of the goals and deliverables of the clinical trial, it also provides for periodic budget revisions to account for factors such as expanded project scope, rising costs and supply-chain changes.
3. Human resource allocation and oversight
The section on project and operations planning highlighted the importance of creating a personnel schematic as well as a responsibility blueprint at the start of a clinical trial. Through this process, a CRPM is able to clearly define roles for various team members in meeting project goals and milestones, and their contributions to each project deliverable.
However, in order to ensure collaborative effort and a cordial work environment, it is essential for a CRPM to also formulate a transparent hiring policy as well as disciplinary policy. These may be specific to the clinical trial or apply broadly across the CRO, or Clinical (/Contract) Research Organization. Well-documented policies facilitate the CRPM’s role in sourcing and motivating the best-fitted staff to play different roles in the clinical team.
4. Clinical data management and quality control
The data from a clinical trial are often its most valuable project outcome. As such, effectively managing the input, storage, analysis and quality control of study data is one of the foremost responsibilities of a CRPM.
Before beginning the active phase of the clinical trial, a CRPM coordinates with team members to put in place the following aspects of data management:
physical data storage system (files, binders, shelves, cabinets, etc.)
electronic data capture (EDC) and management system
physical and electronic data security systems
data input procedure
data cleaning and quality monitoring procedure
data sharing (import, export, access across clinical sites and teams)
data analysis and visualization procedure
periodic data review and reporting procedure
5. Risk management and mitigation
Owing to the high stakes nature of clinical research, running a clinical research study carries numerous risks. One of the major responsibilities of a CRPM is to develop a risk management plan to identify and circumvent potentially risky situations, and to mitigate consequences to the project in cases where an unforeseen risk impacts the trials process.
Some sources of risk in the management of a clinical trial include:
failure to obtain or document subject informed consent
errors in following trial protocol (timing, dosage, subject screening, etc.)
data security breach leading to compromised subject confidentiality
inadequate insurance coverage for potential adverse events of study
financial constraints arising from changes in study funding
limitations on study scope due to revisions in regulatory policy
Bridging the gap: Using ACRPMC to transition from clinical research professional to project manager
The foregoing section outlined how, despite their strong base in clinical research, CRPM aspirants generally lack the advanced knowhow and managerial skills required for leading a clinical research project. CCRPS’ Advanced Clinical Research Project Management Certification (ACRPMC) provides an excellent tool for bridging this gap and bringing candidates up to speed in all domains of clinical research management.
The table below offers a summary of the focus areas of the ACRPMC, detailing how each contributes to enhancing a candidate’s expertise and eligibility for the role of a Clinical Research Project Manager.
ACRPMC Focus Area |
Contribution to CRPM Candidate Eligibility |
ADVANCED REVIEW - I: Regulatory compliance in clinical research |
i.Fundamentals of subject (/patient) safety, ICH-GCP E6, Sections 2 - 4 |
ii.Regulatory compliance – FDA-CFR Title 21, Forms FDA 1571, 1572, 3454, 3455 |
|
iii.Investigational New Drug (IND) & New Drug Application (NDA), Investigational Device Exemption (IDE) |
|
iv.IRB, Data Safety Monitoring Board (DSMB)[8] |
|
ADVANCED REVIEW - II: Clinical trial concepts |
i.Process & phases of clinical testing (pre-clinical and phases 1 to 4) |
ii.Importance of ‘control’ in testing[9], outcome validity, control methods (randomization, blinding) |
|
iii.Subject (/patient) selection[10]: screening & exemption criteria, selection & retention, study compliance |
|
iv.Clinical trial data management[11]: EDC, Clinical Trial Management Systems (CTMS), Interactive Response Technology (IRT), Randomization & Trial Supply Management (RTSM) |
|
v.Subject safety[12]: Risk assessment & Individual Case Safety Reports (ICSRs), Adverse Events (AEs), Adverse Drug Reactions (ADRs), Important Medical Events (IMEs) |
|
ADVANCED REVIEW - III: Pre-trial preparation |
i.Documentation[13]: Regulatory binder, Investigator Brochure (IB), Trial Master File (TMF), Case Report Form (CRF), Delegation of Authority Log (DOAL), etc. |
ii.Site preparation[14]: Site Selection Visits (SSVs), Site Qualification Visits (SQVs), site management agreements, investigator selection |
|
iii.Pre-trial publicity: Advertisement for subject recruitment & retention |
|
ADVANCED REVIEW - IV: Active trial management & trial termination |
i.Clinical trial protocol compliance, deviations & violations |
i.Clinical site monitoring: subject safety, drug storage & safety, regulatory compliance |
|
ii.Data monitoring: data security & access, Quality Management System (QMS), Quality Control (QC), Key Quality Indicators (KQI) |
|
iii.Team monitoring: communication & collaboration, adherence to trial & safety protocols, research integrity & fraud |
|
iv.Reviews & audits[15]: document & site audits, data audits, financial audits |
|
v.Study termination: site close-out visits, data consolidation, subject debriefing |
|
EXPERTISE BUILDING - I: Clinical project management fundamentals |
i.Project management basics[16]: key concepts, Project Management Body of Knowledge (PMBOK) |
ii.Skills of a project manager: technical, administrative, human resources, public relations |
|
iii.Clinical project stakeholders: sponsors, IRB, investigative & administrative staff, site administrators |
|
EXPERTISE BUILDING - II: Advanced clinical project management |
i.Project planning & tracking, progress evaluation metrics |
ii.Financial management[17]: project budgeting, site budgeting, advertising budget, payment tracking and management |
|
iii.Risk management & problem solving[18]: problem solving managerial skills, identifying risks, avoiding failures, resolution of project problems (protocol deviations, compliance failures, project delays) |
Fast-track to CRPM with the ACRPMC advantage
From the above summary table, it can be seen that the ACRPMC[19] program of CCRPS covers the entire spectrum of competencies required for managerial clinical research professionals. In addition to providing in-depth training in clinical project management concepts, tools and techniques, the program includes a review of foundational as well as advanced knowledge of the clinical trials process.
Aside from its comprehensive curriculum, certification through ACRPMC offers major benefits over conventional clinical research management courses, both online programs as well as those offered by colleges and universities. Some of the outstanding advantages of ACRPMC are:
1. Foundational review plus advanced training
The ACRPMC program stands apart from other online programs in its unique ability to launch as well as advance careers in clinical research. The program is equally effective at helping an aspiring graduate (BA in science or BS degree) to gain a competitive advantage in the clinical research job market, as it is at catapulting a senior clinical researcher into a managerial position.
For CRPM aspirants in particular, the ACRPMC provides an unrivaled opportunity to brush up on the basics, in addition to acquiring valuable knowhow in clinical research project management, before embarking on the applications and interview process.
2. Over 100 training modules (250 hours of coursework)
The course comprises over 100 modules. The advanced review focus areas address all aspects of the clinical research process, including important investigative concepts (trial design, randomization, subject screening, data analysis, etc.) as well as administrative processes (maintenance and updating of regulatory documents, case reports, trial logs, etc.). Additionally, the expertise building focus areas of the ACRPMC cover basic and advanced project management concepts and skills that equip candidates to tackle the challenges of leading a clinical research study.
3. ICH-GCP E6R2 compliant
Designed by experienced Clinical Research Project Managers, the ACRPMC curriculum is fully compliant with the regulatory requirements of the ICH-GCP E6R2. The course coordinators additionally ensure that the content is regularly updated to reflect revisions to policy and new requirements.
4. Immediate enrollment and fast-tracked certification
Unlike college and university courses, trainees can enroll in the ACRPMC with just a few clicks. In addition, the self-paced course design allows students to skim through familiar topics, while giving more time and attention to new material. This is especially advantageous for working professionals and senior clinical research professionals wishing to refresh their knowledge. Trainees able to dedicate several hours per day to the program can complete the ACRPMC in as little as two weeks.
5. Multiple accreditations and industry-wide recognition
For ACRPMC-certified trainees, the solid credentials of the program confer a huge benefit when applying and interviewing for clinical research positions. Like other CCRPS courses, the ACRPMC is also accredited to ACCRE (Accreditation Council For Clinical Research and Education), ACCME (Accreditation Council for Continuing Medical Education) as well as ACPE (Accreditation Council for Pharmacy Education).
6. Clinical research résumé building and interview preparation
The final modules of the ACRPMC help trainees in building their ability and confidence to face interviews for clinical research positions. Trainees completing the comprehensive final examination not only have immediate access to a digital certificate, but are eligible to receive a letter of recommendation (LoR) that can strengthen their clinical research job application.
As the clinical research industry continues to grow at an unprecedented pace, there is rising demand for Clinical Research Project Managers who can blend their skill and experience in clinical research with savvy, expert project management abilities. As a professional clinical researcher, the ACRPMC program offers you an unmatched opportunity to refresh existing knowhow and acquire new competencies, thereby leveraging your rise to the top echelons of management.
If you are a fresh graduate, the ACRPMC represents an unequaled, early-career edge in the clinical research arena. By equipping you with foundational as well as advanced knowledge and skills, ACRPMC certification does not merely improve your chances of securing an attractive clinical research position, it assures the rapid upward growth of your career graph.
Advanced Clinical Research Project Manager Certification (ACRPMC) program advantages.
References
https://www.indeed.com/jobs?q=Clinical%20Trial%20Manager&l&vjk=311beece3c2d98b6
https://www.payscale.com/research/US/Job=Clinical_Trial_Manager/Salary
Dixon JR. 1999. The international conference on harmonization good clinical practice guideline. Quality Assurance. 6(2): 65-74. DOI: 10.1080/105294199277860
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.32
https://ichgcp.net/8-essential-documents-for-the-conduct-of-a-clinical-trial
Cullen H. 2016. Effective project management for clinical trials: A business approach. Ebook: https://www.imperialcrs.com/files/Project_Management_Ebook_Final.pdf
Jüni P, Altman DG, Egger M. 2001. Assessing the quality of controlled clinical trials. BMJ. 323(42). DOI:10.1136/bmj.323.7303.42
Farrell B, Kenyon, S, Shakur H. 2010. Managing clinical trials. Trials 11(78) DOI:10.1186/1745-6215-11-78
von Itzstein MS, Hullings M, Mayo H, Beg MS, Williams EL, Gerber DE. 2021. Application of Information Technology to Clinical Trial Evaluation and Enrollment: A Review. JAMA Oncol. 7(10):1559–1566. DOI:10.1001/jamaoncol.2021.1165
Yao B, Zhu L, Jiang Q, Xia HA. 2013. Safety Monitoring in Clinical Trials. Pharmaceutics. 5(1):94-106. DOI: 10.3390/pharmaceutics5010094
https://files.nccih.nih.gov/s3fs-public/CR-Toolbox/Regulatory_Binder_Checklist_ver3_07-17-2015.docx
https://www.appliedclinicaltrialsonline.com/view/selecting-study-appropriate-clinical-sites-3-steps
https://www.clinicaltrialsarena.com/news/how-to-prepare-for-an-fda-site-inspection-5739632-2/
PMBOK® Guide (7th ed.). 2022. Project Management Institute.
Appleson M. 2015. The importance of budgeting in clinical trials and how a budget can prevent billing errors. Clin Invest. 5(5): 437-439. DOI: 0.4155/CLI.15.11
Robinson M. 2005. Clinical trials risk management (1st ed.). CRC Press. DOI: 10.1201/9781420037654
https://app.ccrps.org/courses/Advanced-Clinical-Research-Project-Manager-Certification
Clinical Research vs Clinical Trial
Many people use both terms interchangeably in their clinical research discussions. Although we would not say that it’s a totally wrong thing to say or do, but it is important for us that you know the difference between both terminologies.
Clinical research is the study of people’s health and the illnesses in people. The purpose of clinical research is to prevent diagnose and treat illnesses but more importantly as well, to prevent them. Clinical research describes many elements of scientific investigation. It helps to transform basic medical research that are carried out in the laboratory into new treatments and useful information that are beneficial to the patients. It usually involves the participation of humans.
On the other hand, a clinical trial is an experiment that is designed to create answers and clarifications about possible new treatments or new ways of administering a previously known treatment for more effectiveness. Clinical trials are carried out to determine the safety and effectiveness of using new drugs or types of treatment. It's a long and meticulous process that takes years to finish.
Clinical trials are aimed at evaluating medical, behavioral, or surgical intervention of drugs or treatments in people. They study the role of caregivers, develop tests to find a disease early before there are visible symptoms, and look at how to make life a little better for people living with chronic health problems or life-threatening diseases. Clinical trials cannot be approved by the U.S. Food and Drug Administration (FDA) until clinical research professionals have performed laboratory tests and studies in animals, and it has been proven safe and efficient.
The main distinction between clinical research and clinical trial is that clinical trial is a part of a clinical research.
Clinical trials are part of a long and careful process that is carried out over a long period of time. Firstly, the new treatments are studied in the lab by doctors. Then they usually test the treatment on animals like apes, rats etc, depending in if the fit particular criteria.
If the treatment shows good promises in the animals, then they go ahead to test it on human subjects through clinical trials in the clinical research labs.
So we can safely say that clinical trials is one of the many phases of clinical research.
If you are a prospective clinical researcher, that is, if you are interested in a clinical research career, you can’t afford to miss out on little but vital details like this. Details and knowledge that come from experience are available for you at ccrps.org, where you will work with people willing and ready to help you launch your career forward.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
How to Get into Clinical Research
If you want to get into the clinical research, there are a few steps you will have to go through. In this article, we'll be taking you through the steps and some common questions.
What does Clinical Research entail?
Clinical research entails testing medicines or products for safety and effectiveness. It involves working with patients during extended experiments to record and quantify the effect that different medicines produce. It is a highly regulated field due to the use of human subjects.
Salary earned ranges from $39,000 to $87,000. However, the more one acquires certifications and qualifications, the more opportunities you have. That means you can choose the best position and salary for you.
The first step is to get an education.
Earning a bachelor's degree in a life science or health related discipline by taking specific courses like medicine, pharmacology, biology, molecular biology, genetics, anatomy, biotechnology, nursing, physiology, chemistry, or bioengineering will equip you with the necessary and relevant medical knowledge, science, and technicalities to qualify you into practicing as a clinical research.
Taking courses that are relevant to the clinical research that will give you the necessary experience and knowledge that are relevant to clinical research conducts. Applying for the courses offered at your university or from professional organizations like Certified Clinical Research Professionals (CCRPS) and Association of Clinical Research Professionals (ACRP) are a great place to start. These courses will include topics such as study designs, Good Clinical Practices (GCP), research ethics, drug development cycle, regulatory affairs and U.S as well as international requirements.
You can get a certification from a reputable organization, such as CCRPS, ACRPS, and Society of Clinical Research Associates (SOCRA), as long as you have a Bachelor's design and at least one year of experience in clinical research. This certification allows you gain more access into the clinical research industry.
When you are taking your courses, make sure you study the ICH GCP guidelines and ethics thoroughly. Training in the International Conference on Harmonisation (ICH) Good Clinical Practices (GCP) ethics and guidelines improves your chances of getting hired greatly.
Remember to keep proper documented records of your certifications as well as your education. This will save you a lot of time and stress.
The next step is to gather experience.
The following are ways you can gather experience;
Volunteer - Look for volunteering opportunities around your area and volunteer to help with the projects that will be carried out in the clinical research industry. This helps you get closer to the professionals as well as what to expect at the job. You might be chanced to start out as a clerical worker or a data entry staff, but not to worry, you'll be able to work your way up the ladder. Once you are in the field, you can discuss the possibility of applying for a position with the place you are working at in the future. Employers will be more likely to consider you when there is someone in the company vouching for you.
You can volunteer at clinical research professionals organizations related to the clinical research field or medical field, medical centers or hospitals, International Review Boards (IRB) or Research Ethics Committees.
Research Projects - Most entry level jobs require around two years of experience. Taking up clinical research monitoring projects for a few years can really help you get the experience you need. You can also conduct research studies with human subjects during your pursuit of a bachelor's degree or graduate degree.
Internships - Seek out an internship with medical firms, biotechnology, and pharmaceutical companies while you're still in college. You may or may not get paid as an intern but it's nothing compared to the experience you'll gain that will be needed for your venture into clinical research.
Finally, the last step is to apply for entry-level positions.
This is the last step that will get you right into the world of clinical research. After all your education and gathered experience, you cam apply for an entry-level position as a Clinical Research Coordinator (CRC) or a Clinical Trial Assistant (CTA). Both positions only require around two years of experience and they are the ones that you can qualify for. Applying for high-level positions you don’t qualify for yet will only waste your time.
Generally, you should apply for positions at smaller firms. It's okay to aim for positions at the biggest pharmaceutical companies and clinical research organisations (CROs), but as a newcomer, the competition may just be too high. So, why not just apply for positions at smaller firms and work your way to the top?
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
Joining the ICH-GCP Clinical Research Program
Clinical research is one of the best career path to get involved in. They have positions for every lifestyle and personality. However, a solid understanding of the rules and regulation of the field is critical for every professional in the field. In this article, we will talk about the GCP and how it should impact the way you approach clinical research.
About the GCP
Good Clinical Practice (GCP) is an international standard provided by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). GCP enforces strict guidelines on ethical aspects of the clinical study.
Individuals who are aware of the significance of very good clinical practice guidelines and the role of the clinical research know the importance of online GCP programs.
Medical professionals who have successfully completed their clinical research training program can improve their expertise on regulatory authorities and approval specifications for the marketing of the healthcare products. This can make a big change in their work life. A good training program can help them improve their proficiency in the best use of medical data, databases and data evaluation. This will help them build proficiency in the communication, research and management, educational approaches, problem-solving and other things related to the clinical research.
Make a better informed decision
The salary is one of the main factors considered by people planing to choose a degree or certification program. Here, you can find the average clinical research salary in your area and decide on whether a career in the clinical research.
If you wish to become a certified clinical research professional, then you have to find out and join in the program specially designed for career.
Clinical research involves drug development as well as healthcare research. Experts in this profession engage in the patient-focused research and make use of every chance to be successful in the clinical research career.
CCRPS visitors learn about clinical research and are able to make an informed decision to join the best program for them. When you have questions, you can have instant assistance from the experienced and committed professionals. We ensure our students understand about everything associated with the clinical research degree program and use every opportunity to be successful in the clinical research sector.
Improve your resume now with online clinical research certification or membership in clinical research societies.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course
What Is a Clinical Research Coordinator
The clinical research is a ground breaking field in the world of medical advancement and as such, has a wide variety of professionals that are changing and channeling the drive.
We will be taking a look at one of the highest paying certified clinical research professionals, clinical research coordinator.
CLINICAL RESEARCH COORDINATOR
The clinical research coordinator is responsible for conducting trials as per the GCP guidelines under the supervision of the Principal Investigator (PI). Although the PI carries the overall responsibility for performing the trial, the CRC is the heart and soul of the clinical trial and that, ultimately, it is the CRC who carries ahead the research objectives and ensures the success of the clinical trial.
Having a certification in clinical research in other to become a clinical research coordinator is not compulsory, but certification enables one to show that they have met the necessary requirements and have gained job-relevant knowledge and skills. This distinction is very important to pharmaceutical companies and contract research organizations, who frequently hire clinical research staff.
EDUCATIONAL REQUIREMENTS
• High school diploma and 6,000 hours of experience.
• An associate degree in clinical research fields amd 4,500 hours of experience, or
• A Bachelor's, Master's, or Registered Nurse degree and 3,000 hours of clinical research experience.
You can come from a variety of medical sciences or health related fields, or from a nursing background as a RN. Courses offered in hospital and clinical related ethics, team management, and research methodologies will be especially valuable.
Who Will Hire Clinical Research Coordinators?
Pharmaceutical Organizations
Contract Research Organizations
Universities
Hospitals
SPECIALIZATIONS
They focus on the following;
1) Participating in preparation and management of research budgets and monetary disbursements.
2) Informing patients or caregivers about study aspects and outcomes to be expected.
3) Communicating with laboratories or investigators regarding laboratory findings.
4) Ordering drugs or devices necessary for study completion.
5) Directing the requisition, collection, labeling, storage, or shipment of specimens.
6) Arranging for research study sites and determine staff or equipment availability.
7) Reviewing scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
SALARY
Clinical research coordinators have had a positive trend of pay for experience. Therefore a CRC with less than 5 years experience is paid an average total compensation of $43,000 (based on 1,237 salaries). Employees with 5 to 10 years experience can expect the average compensation of $51,000 (based on 429 salaries). Employees with 10 to 20 years of experience is paid an average compensation of $55,000 (based on 265 salaries). Finally, employees with more than 20 years of experience can expect a compensation of $62,000 (based on 52 salaries).
While many stay CRCs their entire career, most will move to higher postions after 3-5 years of experience. One of the most popular careers CRCs switch to is CRA, which can pay up to $300k.
Take courses from CCRPS and learn more on how to become a clinical research professional.
Discover more from Clinical Research Training | Certified Clinical Research Professionals Course