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7 Reasons Why You Should Get into Clinical Research

Have you ever thought that there’s a perfect job out there for you, but you just haven’t found it yet? If you are motivated, informed, and interested in a science and medical career, you might have just found your answer. The future in clinical research is bright, and it is one that you will want to be a part of.

The clinical research industry is a highly lucrative and expanding field. The global clinical trials market has been estimated at $80.7 billion in 2024. As the push for new vaccines and therapeutics climbs, the field value is expected to grow even more. Experts predict that the global market will hit $123.5 Billion By 2030.

Contrary to popular belief, working in clinical research doesn’t have to mean you have to stay in a lab. There are demands and opportunities for every skill set, if you know how to find them. Below, I have put together an in-depth guide on why you should get into clinical research.

  • You like to a job that’s flexible

Don’t like working in a cubical? How about heading to the airport every morning instead? If you like a job that keeps you moving, then becoming a Clinical Research Associate (CRA) might be the right move for you.

CRAs, contrary to what most believe, don’t collect data or interact with patients. A CRA’s job is to travel between different research sites and verify data transcription. They are called “monitors” because it is their job to ensure that every site is following proper compliance and protocols.

There are two types of CRAs: home base and in-house. Home base CRAs work remotely. That means they work and travel from home. If you get tired of working from home, you can become an in-house CRA. In-house CRAs stay in one site and work together with a home base CRA to keep each other updated with what is happening at their site.

  • You like working with people

Have you ever been told that you are a people person? If talking to new people everyday sounds like something you’d enjoy, you should definitely look into becoming a Clinical Research Coordinator (CRC).

CRCs are the backbones to every project. They conduct patient visits, input source documents into the electronic data capture (EDC), and ensure that every trial is following compliance. They are also responsible for handling regulatory documents and updating the Principal Investigator (PI) with trial results.

CRCs conduct a variety of tasks, all of which impact the progress and development of the trial. Every successful clinical trials team needs a good CRC. So, if you have strong interpersonal skills and know how to stay organized, you will be indispensable.

  • You are tech-savvy

Are you a self-proclaimed techie? Perhaps you’ve dabbled in coding, pick up computer programs easily, and maybe even have a background in IT. Technology is the future. If you think you have a knack for organizing data, you should look into becoming a Clinical Trial Assistant (CTA).

CTAs, also known as Clinical Research Assistants, manage the Trial Master File (TMF). They file, archive, and maintain trial documents and study files. They are also responsible for closing inquiries from the CRA, as well as providing administrative support to the research team. Every important step in clinical research, pre-clinical research, study startup, site management, needs a dependable CTA.

While most jobs in clinical research require some understanding of technology, it is especially important for the CTA to know what they are doing when it comes to managing trial documents and study files. In addition, it is equally important that the CTA is organized and pays attention to detail.

  • You like a good salary with room for promotion

Current Salary Data (USA, 2024):

  • CRAs:

    The salary progression for CRAs with experience (one to two years - $72,358, seasoned - $110,102) and individual contractor CRAs (up to $300,000) can stay as is.

  • General salary comparison: The point about the average US base salary being $40,000 and CTA/CRC salaries being good for entry-level positions remains valid.

salaries can vary depending on location, experience, and specific employers.

You don’t want to go back to school

In clinical research, experience is often valued over degrees. Rather what you didn’t study in college, hiring managers are more interested in what you have done in the past and how they can integrate you into their company. While graduate programs can help point you in the right direction, you don’t need a master’s degree to succeed in clinical research. In fact, certain positions don’t even require a bachelor’s or associate’s degree.

Applying to CRC and CTA positions are one of the most common segways into higher positions in clinical research. CRCs don’t need a bachelor’s or associate’s degree to get their foot in the door. While both CTA and CRA positions require a bachelor’s degree, they don’t have to be in the life sciences.

One of the best ways to gain experience and stand out from the crowd is to have on-site experience. If you need advice on how, Dan Sfera, the CEO of DSCS CRO Clinical Research Services, recommends getting started by interning or volunteering at clinics and research sites to build connections and experience. Sometimes, the easiest way to get involved is to offer services like patient recruitment and social media management in exchange for opportunities to build your CV. By appealing to a site’s needs, this will help you get your foot in the door and build the connections and resume you need.

Another great way of adding experience to your resume is by training through certification courses. When employers see that you have taken the time and effort to understand how to be the best in their field, they are more far likely to hire you. At CCRPS.org, we offer seven courses and certification trainings to give you an advantage. 82% of our students are hired within the first month of taking the course. We are accredited by the Accreditation Council For Clinical Research & Education (ACCRE) and tailor our course to you. For example we offer special courses for nurses and an accelerated certification + internship opportunity for anyone with minimal or no clinical experience.  

You come from a different field

Switching career fields can be nerve wracking. However, it is also an opportunity for you to be a unique candidate. Whether you come from a closely-related background, like medicine or nursing, or something completely different, there are ways you can advocate for yourself in front of employers.

If you already have a background in medicine, your knowledge of healthcare and your passion for patient health will make for a smooth translation into clinical research. In addition, your RN or MD degrees will help you gain a competitive edge and allow you to climb higher positions, such as the PI, who is the primary researcher of an operation.

On the other hand, if you come from a less relevant field, you can still leverage yourself to be exactly what the clinical research field needs. For example, if you are a teacher, your communication and interpersonal skills will be your keys to success. If you are a lawyer, your ability to draft and read papers will far surpass the average candidate. If you studied mathematics, you are a skilled problem solver. If you are a translator, your language skills are valuable and will help you get into roles that require it. In short, whatever skills helped you succeed in your previous positions, you can bring it with you to clinical research.

You want to make a difference in the world

There are two types of people in the world: ones who accept the world as it is, and ones who strive to change it. In the last 50 years, science and medicine have gone through a series of drastic changes. However, anyone who works behind the scenes will tell you that medical breakthroughs are not miracles. Clinical research is the culmination of human effort and intelligence. The fruits and labor of the ever-expanding industry are proof that if enough people care about the world, then they can change it. While there are many good reasons to work in clinical research, if you want the privilege to enrich the lives of others, there is a place for you in this field.

If you want to take a sneak peak at employers and opportunities near you, jobs sites like Indeed are a great resource.

Here are links for aspiring CRAs, for CRCs, and for CTAs. (Note: CTAs are often referred to Clinical Research Assistants, not to be confused for Clinical Research Associates)

Unlocking Your Future in Clinical Research: Discover the Perfect Career Path for You

Clinical Research Coordinator

Take courses from CCRPS and learn more on how to become a clinical research professional.

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How to Save Money on Becoming a Clinical Research Coordinator (CRC)

If you think practically, then you will find that nothing in this world comes for free. But if you have a passion for clinical research and need to learn on a budget, here are some ways you can enhance your understanding without breaking the bank.

To understand how you can learn for free, it’s first important to understand the typical trajectory of a clinical research coordinator:

  • A person seeking clinical research coordinator training should complete high school. There they learn must-have all the science subjects like physics, chemistry, and biology.

  • After high school, institutes for professional clinical research coordinator professionalism offer programs that are essential for later.

  • In addition, one can get an experience graduate certificate from an online source. This would help the person reach their career goals faster.

  • Alternatively, they can complete a bachelor's degree of science.

  • After completing the bachelor's degree, a master's degree is needed for some of the higher pay-grade positions.

How to get free clinical research coordinator training?

If looking at the education requirements for a clinical research coordinator makes you dizzy, you’re not alone. Becoming a clinical research coordinator takes a lot of time and money. That is why many students turn to scholarships and healthcare programs to help pay their tuition.

On the other hand, there are many websites that offer free or affordable information and training for aspiring professionals. While they can’t replace a formal education, they can supplement your resume and knowledge. While some important topics include clinical data management, pharmacovigilance, and regulatory authorities, you should strive for a comprehensive understanding of the field. At CCRPS, we offer affordable courses designed for clinical research coordinators as well as free ICH GCP training. These can help you build your resume and land the position you want.

In addition, it is really important to keep updated with new clinical research headlines. Below, I have complied some articles that aspiring professionals might find useful. The best thing you can do for your education is to start now and not later.

Take courses from CCRPS and learn more on how to become a clinical research professional.

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How Clinical Research Certification Could Help You Land a Job

Clinical research courses are very important for a variety of clinical research positions that require different skill sets. To find the right job opportunity, there are a number of key factors which you should consider while finding a training course.

As a clinical researcher, you should know your long-term and short-term goals. Then, you should develop the skill sets and gain the experience to reach them. For example, if your goal is to move in from a Clinical Research Coordinator (CRC) to a Clinical Research Associate (CRA), you should start building skills that a regional associate or a monitoring role would find valuable. Sometimes that can be as easy as taking on more diverse tasks at your current position, or taking an online CRA course.

Benefits of holding clinical research certification

According to the clinical association research profession, the evidence indicated to the regulatory bodies that certification reduces the risk factor to work in a research subjects.

It has been shown that trials have fewer errors, lower costs or more rapid turnaround, and higher safety in clinical trials when certified professional trainees are involved.

Certifications can help demonstrate to employers your confidence and abilities, as well as your long-term and short-term goals and how they might benefit the company. For CROs, employees with certifications will improve their company’s marketability and standards. Certification in areas like Pharmacovigilance or ICH-GCP can be particularly valuable.

Certification will make you more competitive in the industry to allow you to stand out.

If a company interviews you and another candidate with equal experience and education, their manager will be more likely to hire the candidate who has a certification.

If you have a certification, you can negotiate for higher salary. Getting certified, especially in specialized roles such as Clinical Trials Assistant Training, Advanced Clinical Research Project Manager Certification, or Advanced Principal Investigator Physician Certification, will open more opportunities to you, where you can be hired for more senior and better paid positions within the company.

Even though there are enormous job vacancies in this field, employers will only hire skilled applicants that can do the job. A certification is a formal recognition for your skills, experience and performance. It will help validate your resume, especially when they are compared to other applicants’.

There are lots of clinical research online certification courses where you can study under best universities. To understand more, you can visit ccrps.org to understand their online certification course work, as well as any questions about the clinical research exam. Below, we have complied some helpful articles to help you excel in the field.

Take courses from CCRPS and learn more on how to become a clinical research professional.

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What is a Clinicals Research Specialist

Clinical research specialists play a pivotal role in the realm of healthcare, collaborating within laboratory settings alongside technologists, technicians, and supervisors to conduct crucial clinical lab tests. These professionals are instrumental in the discovery, diagnosis, treatment, and monitoring of various illnesses. While their specific responsibilities may vary based on training and workplace, they typically focus on specialized lab tests or procedures, such as bacteria or parasite identification, fluid analysis, drug level testing, specimen preparation, cell counting, and culture creation. Apart from technical proficiency, they are equipped with essential communication, interpersonal, individualized, and precision skills.

JOB SPECIFICS OF A CLINICAL RESEARCH SPECIALIST

  • Enrollment Tracking and Documentation: Clinical research specialists meticulously track the enrollment status of subjects and document dropout information to ensure study integrity.

  • Continuous Learning: They stay abreast of the latest developments in clinical studies by reviewing scientific literature, attending conferences, and seminars.

  • Problem Identification and Resolution: Identifying protocol issues, informing investigators, and contributing to problem resolution efforts are integral aspects of their role.

  • Documentation Preparation: These professionals prepare various study-related documents, including protocol worksheets, procedural manuals, adverse event reports, and progress reports.

  • Collaboration: They collaborate with healthcare professionals to devise effective recruitment strategies for studies.

  • Quality Assurance: Participating in quality assurance audits and managing research budgets are part of their responsibilities.

  • Protocol Review: Reviewing proposed study protocols and assessing factors like sample collection processes and subject eligibility is crucial.

  • Subject Recruitment: Assessing potential subjects' eligibility, developing advertising materials, and maintaining contact with sponsors for recruitment purposes are key tasks.

  • Salary Insights: The national average salary for clinical research specialists is $52,437.

Clinical research specialists have diverse employment opportunities, including roles in:

  • Pharmaceutical companies

  • Government-based organizations like the Medicines and Healthcare products Regulatory Agency (MHRA)

  • Non-governmental organizations (NGOs)

  • Health charities

If you aspire to join this dynamic field, consider enhancing your skills and knowledge with courses from CCRPS (Clinical Research Professional Society). Explore our comprehensive offerings to embark on a fulfilling career journey:

  • Clinical Research Coordinator: Course Link

  • Pharmacovigilance Certification: Course Link

  • CRA (Clinical Research Associate): Course Link

  • ICH-GCP (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice): Course Link

  • Clinical Trials Assistant Training: Course Link

  • Advanced Clinical Research Project Manager Certification: Course Link

  • Advanced Principal Investigator Physician Certification: Course Link

  • Medical Monitor Certification: Course Link

Enroll today and pave your way to a successful career in clinical research!

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What is the Best CRA Training Program for You?

To any CRA, proper training and certification is critical. After all, employers want to hire applicants that are proficient and knowledgeable. At CCRPS, we can help jump start your career with our flexible, ACCRE accredited program. In addition, check out some of our other CRA articles below to learn more about the field and position.

Take courses from CCRPS and learn more on how to become a clinical research professional.

Enhance Your Skills with Specialized Training:

If you're looking to specialize in specific areas within clinical research or further develop your expertise, consider enrolling in our comprehensive courses:

  • Clinical Research Coordinator: Dive deep into the responsibilities and intricacies of coordinating clinical trials. Enroll here.

  • Pharmacovigilance Certification: Master the principles and practices of drug safety monitoring. Enroll here.

  • CRA (Clinical Research Associate): Hone your skills as a CRA and excel in managing clinical trial conduct. Enroll here.

  • ICH-GCP (International Conference on Harmonisation - Good Clinical Practice): Understand the global standards for conducting clinical trials. Enroll here.

  • Clinical Trials Assistant Training: Learn the essentials of supporting clinical trial operations effectively. Enroll here.

  • Advanced Clinical Research Project Manager Certification: Elevate your career with advanced project management skills tailored to clinical research. Enroll here.

  • Advanced Principal Investigator Physician Certification: Equip yourself with the expertise needed to lead clinical trials as a principal investigator. Enroll here.

  • Medical Monitor Certification: Gain the necessary skills to oversee clinical trial safety and medical aspects effectively. Enroll here.

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Clinical Research Managers: Principal Responsibilities and Duties

Responsibilities and Duties

Clinical research managers are involved with the monitoring of all processes in clinical trials. They oversee the administration and staff of such trials. For example, they need to supervise the CRAs on-site and in-house monitoring and filing of the trials.

When one is a clinical research manager, it means that they have to oversee those FD regulations, good clinical practice, and SOPs are all adhered to. They are also required to offer assistance in the development and implementation of different clinical, programs, procedures, and processes.

Qualifications

Certification is very important in any career. For clinical research managers, they need to complete very specific professional exams. This is determined as per the region, by the rules set by the regulatory bodies For instance, in some areas a clinical research manager needs to have a nursing master’s degree.

First level managers

First level managers have to ensure that all the department or project milestones and goals are all met while sticking to the budgets approved by the top management. They must have the most extensive knowledge about the department, since they operate with all their processes. In most cases, clinical research managers need 5 years of experience in a particular field before moving up to more senior positions.

Clinical trial manager

These managers supervise and execute clinical trials. They also guide and oversee the clinical data managers and clinical research associates. Clinical trial manager needs to report to the CPM or the clinical project manager.

Explore our courses: Clinical Research Coordinator

Pharmacovigilance Certification

CRA

ICH-GCP

Clinical Trials Assistant Training

Advanced Clinical Research Project Manager Certification

Advanced Principal Investigator Physician Certification

Medical Monitor Certification

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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.

Data manager

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.

Clinical research scientist

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.

Exploring Career Opportunities in Clinical Research

Courses:

  1. Clinical Research Associate (CRA) Training - This course covers the responsibilities of a clinical monitor, including case report reviews, data filing, and product accountability investigations. Learn the skills necessary to excel in this vital role.

  2. Clinical Research Coordinator (CRC) Certification - Gain the knowledge and expertise needed to direct clinical trials alongside principal investigators. Learn best practices for patient enrollment, screening, and site management.

  3. Data Management in Clinical Research - Explore the fundamentals of data management in clinical trials. Develop analytical, strategic, and meticulous skills necessary for organizing and maintaining trial data effectively.

  4. Advanced Clinical Research Scientist Training - Delve into the specialized field of clinical research science, requiring advanced experience and expertise. This course prepares individuals with a PhD or MD for conducting complex trials and navigating the challenges of the field, including extensive travel.

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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.

Unveiling the Role of Clinical Research Associates

Clinical Research Coordinator: Dive into the responsibilities and skills required for effective clinical research coordination.

  1. Pharmacovigilance Certification: Explore the essential aspects of pharmacovigilance to ensure drug safety and regulatory compliance.

  2. CRA (Clinical Research Associate): Delve into the core responsibilities and duties of a Clinical Research Associate in managing clinical trials.

  3. ICH-GCP: Understand the principles and guidelines outlined by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP).

  4. Clinical Trials Assistant Training: Acquire the foundational knowledge and skills necessary to support clinical trial operations effectively.

  5. Advanced Clinical Research Project Manager Certification: Elevate your expertise in clinical research project management with advanced certification training.

  6. Advanced Principal Investigator Physician Certification: Gain advanced certification tailored for Principal Investigator Physicians involved in clinical research studies.

  7. Medical Monitor Certification: Explore the critical role of medical monitoring in ensuring the safety and integrity of clinical trials.

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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.

Exploring Icon Clinical Research: Driving Innovation in Drug Development

Courses:

  1. Clinical Research Coordinator: Understand the role of Clinical Research Coordinators in facilitating efficient clinical trials, aligning with Icon's mission to fast track drug development.

  2. Pharmacovigilance Certification: Learn about pharmacovigilance practices to ensure drug safety and compliance with regulatory standards, crucial for Icon's commitment to quality.

  3. CRA (Clinical Research Associate): Dive into the responsibilities of Clinical Research Associates in managing clinical trials, aligning with Icon's focus on reducing time to market products.

  4. ICH-GCP: Explore the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines, essential for maintaining quality standards in clinical research, a priority for Icon.

  5. Clinical Trials Assistant Training: Acquire the necessary skills to support clinical trial operations effectively, contributing to Icon's goal of increasing the quality of products.

  6. Advanced Clinical Research Project Manager Certification: Elevate your expertise in clinical research project management, aligning with Icon's specialized services throughout the product development life cycle.

  7. Advanced Principal Investigator Physician Certification: Gain advanced certification tailored for Principal Investigator Physicians, crucial for conducting local trials and global programs supported by Icon.

  8. Medical Monitor Certification: Explore the critical role of medical monitoring in ensuring the safety and efficacy of clinical trials, aligning with Icon's commitment to exceeding quality standards.

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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:

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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.

Clinical Research Coordinator: Gain foundational knowledge and skills essential for coordinating clinical research studies.

  1. Pharmacovigilance Certification: Understand pharmacovigilance practices crucial for ensuring drug safety in clinical research settings.

  2. CRA (Clinical Research Associate): Dive into the responsibilities and duties of Clinical Research Associates in managing and monitoring clinical trials.

  3. ICH-GCP: Learn about the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines essential for ethical clinical research.

  4. Clinical Trials Assistant Training: Acquire the necessary skills to support clinical trial operations effectively.

  5. Advanced Clinical Research Project Manager Certification: Elevate your expertise in clinical research project management.

  6. Advanced Principal Investigator Physician Certification: Gain advanced certification tailored for Principal Investigator Physicians involved in clinical research studies.

  7. Medical Monitor Certification: Explore the critical role of medical monitoring in ensuring the safety and efficacy of clinical trials.

Discover more from Clinical Research Training | Certified Clinical Research Professionals Course

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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.

Unveiling the Vital Role of Clinical Research Coordinators

Courses:

  1. Clinical Research Coordinator: Dive into the essential responsibilities and skills required for effective coordination of clinical trials.

  2. Pharmacovigilance Certification: Understand pharmacovigilance practices crucial for ensuring drug safety in clinical research settings.

  3. CRA (Clinical Research Associate): Explore the responsibilities and duties of Clinical Research Associates in managing and monitoring clinical trials, under the guidance of Clinical Research Coordinators.

  4. ICH-GCP: Learn about the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) guidelines essential for ethical clinical research, fundamental for Clinical Research Coordinators.

  5. Clinical Trials Assistant Training: Acquire the necessary skills to support clinical trial operations effectively under the supervision of Clinical Research Coordinators.

  6. Advanced Clinical Research Project Manager Certification: Enhance your expertise in clinical research project management, crucial for Clinical Research Coordinators in managing research teams and budgets.

  7. Advanced Principal Investigator Physician Certification: Gain advanced certification tailored for Principal Investigator Physicians involved in clinical research studies, working closely with Clinical Research Coordinators.

  8. Medical Monitor Certification: Explore the critical role of medical monitoring in ensuring the safety and efficacy of clinical trials, a responsibility overseen by Clinical Research Coordinators.

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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), and 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:

  1. 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.

  2. 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.

  3. 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

  1. https://www.indeed.com/jobs?q=Clinical%20Trial%20Manager&l&vjk=311beece3c2d98b6

  2. https://www.payscale.com/research/US/Job=Clinical_Trial_Manager/Salary

  3. Dixon JR. 1999. The international conference on harmonization good clinical practice guideline. Quality Assurance. 6(2): 65-74. DOI: 10.1080/105294199277860

  4. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.32

  5. https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research

  6. https://ichgcp.net/8-essential-documents-for-the-conduct-of-a-clinical-trial

  7. Cullen H. 2016. Effective project management for clinical trials: A business approach. Ebook: https://www.imperialcrs.com/files/Project_Management_Ebook_Final.pdf

  8. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/establishment-and-operation-clinical-trial-data-monitoring-committees

  9. Jüni P, Altman DG, Egger M. 2001. Assessing the quality of controlled clinical trials. BMJ. 323(42). DOI:10.1136/bmj.323.7303.42

  10. Farrell B, Kenyon, S, Shakur H. 2010. Managing clinical trials. Trials 11(78) DOI:10.1186/1745-6215-11-78

  11. 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

  12. Yao B, Zhu L, Jiang Q, Xia HA. 2013. Safety Monitoring in Clinical Trials. Pharmaceutics. 5(1):94-106. DOI: 10.3390/pharmaceutics5010094

  13. https://files.nccih.nih.gov/s3fs-public/CR-Toolbox/Regulatory_Binder_Checklist_ver3_07-17-2015.docx

  14. https://www.appliedclinicaltrialsonline.com/view/selecting-study-appropriate-clinical-sites-3-steps

  15. https://www.clinicaltrialsarena.com/news/how-to-prepare-for-an-fda-site-inspection-5739632-2/

  16. PMBOK® Guide (7th ed.). 2022. Project Management Institute.

  17. 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

  18. Robinson M. 2005. Clinical trials risk management (1st ed.). CRC Press. DOI: 10.1201/9781420037654

  19. https://app.ccrps.org/courses/Advanced-Clinical-Research-Project-Manager-Certification

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Clinical Research vs Clinical Trial

Understanding the nuances between clinical research and clinical trials is paramount for aspiring clinical research professionals. While these terms are often used interchangeably, it's essential to grasp their distinctions to navigate the field effectively.

Exploring Clinical Research and Clinical Trials

Clinical Research Coordinator Training

Embark on your journey into the realm of clinical research with our specialized Clinical Research Coordinator course. Gain insights into the fundamental principles of research coordination, setting a solid foundation for your career aspirations.

Pharmacovigilance Certification

Ensure safety and efficacy remain at the forefront of clinical trials with our comprehensive Pharmacovigilance Certification course. Learn to uphold stringent pharmacovigilance standards, safeguarding patient welfare throughout the research process.

CRA Training

Equip yourself with the essential skills needed to thrive in clinical research roles through our dynamic CRA course. Delve into regulatory compliance and monitoring techniques, preparing you to excel as a Clinical Research Associate.

Bridging the Gap: Clinical Research vs. Clinical Trials

While clinical research encompasses a broad spectrum of scientific inquiry into human health, clinical trials represent a specific subset within this realm. Clinical trials serve as structured experiments aimed at evaluating the safety and efficacy of new treatments or treatment modalities.

ICH-GCP Compliance

Adherence to Good Clinical Practice (GCP) guidelines is paramount for the integrity and credibility of clinical trials. Explore the principles of ICH-GCP through our specialized ICH-GCP course, ensuring your research endeavors adhere to the highest ethical and regulatory standards.

Clinical Trials Assistant Training

Facilitate the seamless execution of clinical trials with our comprehensive Clinical Trials Assistant Training. Acquire the practical skills and knowledge needed to support research teams effectively throughout the trial lifecycle.

Empowering Your Clinical Research Career

As you embark on your journey toward a rewarding career in clinical research, leverage the expertise and resources available at ccrps.org. Our courses are meticulously designed to equip aspiring professionals with the requisite skills and knowledge to thrive in this dynamic field.

For those looking to further advance their expertise, consider our Advanced Clinical Research Project Manager Certification and Advanced Principal Investigator Physician Certification. These programs are designed to deepen your understanding and enhance your capabilities in leading complex research projects.

Take the first step towards realizing your clinical research ambitions by enrolling in our specialized courses at CCRPS. Explore the intricacies of clinical research, enhance your understanding of clinical trials, and unlock a world of opportunities in the realm of healthcare innovation.

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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.

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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.

Relevant Course Links

For individuals eager to excel in clinical research, enrolling in specialized courses can provide a significant advantage. Here are some relevant courses offered by CCRPS:

Empowering Your Clinical Research Journey

At CCRPS, we empower aspiring clinical researchers to make informed decisions about their education and career paths. Our programs provide comprehensive insights into the clinical research sector, ensuring that students are well-prepared to thrive in this dynamic field. With experienced professionals dedicated to your success, you'll have the support you need to excel in clinical research.

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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. Consider enhancing your qualifications with a Clinical Research Coordinator certification from CCRPS.

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. Explore further with courses like ICH-GCP, Clinical Trials Assistant Training, and Advanced Clinical Research Project Manager Certification to deepen your expertise.

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. You can also gain specific certifications like Pharmacovigilance Certification and Medical Monitor Certification to further specialize in your field.

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. Prepare for this role with a CRA certification from CCRPS.

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How to Become a CRA and Succeed

The Clinical Research Associate (CRA) is one of the most popular entry-level job in the clinical research sector. It is also one of the most competitive and lucrative positions for new hires. How do you stand out from hundreds of other applicants? You need to build field intelligence and experience.

Knowledge is power in the clinical research industry. For example, did you know that there are loads of differences between the clinical trial and clinical research? If you pay attention to learning the critical details of the field, employers will see and appreciate the effort you put into understanding the field.

There are many institutions that provide clinical research courses for aspiring professionals. However, CCRPS' reputation for the best-in-class programs is offered at the competitive prices is unbeatable. Our world-class facilities is known for teaching both basic and advanced lessons that help professionals in clinical research.  

Improve your Clinical research job qualifications 

To become a CRA, you’ll need an undergraduate degree in medical science, life science, biotech or nursing and a certification. Alternatively, you can use your diploma from a clinical research program from a reputable institution. If you have a graduate degree in the clinical research, then you are eligible for senior level positions and a higher pay grade.  

In addition to your degree, individual should demonstrate their interest by joining a clinical research associate program from a trustworthy institution, such as our CRA certification. There are many specific skills required to become a qualified clinical research associate, and they aren’t always taught in every programs. You must understand the healthcare system, clinical research, healthcare regulation and procedures and other things for successfully regulating the growth of the healthcare products. 

Presently, individuals who want to become a CRA should be capable of preparing a clinical development plan and ensuring the clinical trial data. They should have the overall understanding of the liabilities and responsibilities of performing the study with human subjects. They have to know all the challenges and restrictions of implementing and retaining databases. 

At CCRPS, our program will walk you through what you need to know to become a CRA. Our AACRE accredited program is curated by real life professionals with years of direct experience in clinical research. Best of all, you can learn at your own pace. With our flexible online learning model, you can take your education anywhere you do. Enroll and start working toward your dream career through our online CRA certification program today. If you’d like to learn more, check out some of our other CRA articles below or explore additional programs like our ICH-GCP course, Clinical Research Coordinator course, and the Pharmacovigilance Certification.

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What is a Clinical Research Epidemiologist

Few careers can impact human health and global policies the way a clinical research epidemiologist does. People walking this careers in public health path have the exciting task of discovering how and why diseases happen and prevent the spread and recurrence of these diseases.

A clinical epidemiologist studies diseases and provides information to public health networks about disease prevention and control.

Requirements for Epidemiologists

EDUCATION

Education in the following fields is highly useful in preparing for a future career as a clinical research epidemiologist:

• Biological sciences

• Statistics

• Physical sciences

• Immunology

• Biostatistics

Courses like the ICH-GCP Certification and Advanced Principal Investigator Physician Certification offer focused training that aligns well with the needs of a clinical research epidemiologist.

SKILLS

A master's degree with a specialization in public health is the common education requirement for clinical epidemiologists.

Epidemiologists are often called upon to provide community outreach and public health information services, which makes skills such as critical thinking, communication, and a knack for teaching important for success in the field. Explore the Clinical Research Coordinator and Clinical Trials Assistant Training to develop these essential skills.

SPECIALIZATIONS

There are several specializations people interested in clinical research epidemiology can pursue. These lead to different, but uniquely rewarding career paths. The following specializations are among the most common:

• Infectious diseases

• Chronic diseases

• Bioterrorism

• Injuries

The key is for students to find specializations that spark their interests. Consider enhancing your expertise with certifications like the Pharmacovigilance Certification or the Advanced Clinical Research Project Manager Certification to broaden your career opportunities in these areas.

SALARY

Pay for an epidemiologist is $65,270 per year or $31.38 per hour. The income varies greatly depending on the industry. These professionals work in a variety of environments, such as an office, lab, or a medical setting with doctors. Check here for postings near you.

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Clinical Research Certification Can Lead to a Higher Salary

If you like science and you want to work for an exciting, in-demand field, then clinical research may be a great fit for you. The clinical research field is developing at an amazing rate and opening up a broad scope of job opportunities for qualified professionals.

There is a huge demand for professionals that specialize in clinical data management, test management and managing ethical problems related to clinical research. This presents an impressive career choice with extensive growth potential.

With such a huge expansion of clinical test labs, clinical research degree programs is growing rapidly.

Your clinical research degree from an accredited society:

Clinical research courses are designed to change those with a Life Sciences Bachelor’s into skilled professionals that will bring value to the firms that hire them. Classes include clinical research basics and theories, internships, and improvement of soft skills that will improve your employment prospects.

Getting a Master’s in Clinical research degree will qualify you for a broad range of financially satisfying career paths. The MS in Clinical Research can pave way for those with a bachelor degree, as well as clinical scholars, physician-scientists, and biomedical researchers.

This degree trains you to manage patient-oriented study, directly communicating with human problems to completely know the disease, the growth of healing interventions, and the execution of clinical tests. You will discover how to handle epidemiological and behavioral investigations as well as explain problems associated with outcomes-based research. In addition, you will learn to strengthen your grant reporting and information analytic abilities.

If you are considering a clinical research degree, there are some fields and employers you should consider:

  • Contract Research Organizations (CRO)

  • Biotech Companies

  • Pharma Industries

  • Pharmacovigilance (Pharmacovigilance Certification)

  • Medical Writing

  • Patient Recruitment Organizations (PRO)

  • Regulatory Affairs

  • Clinical Data Management

  • Research labs

  • Logistics Services

  • Options for research basics

  • Clinical Trial Audits

Every clinical research quotes require a chief researcher to lead the study. These researchers could be any of the following:

  • Researchers

  • Professor

  • Medical Practitioners

  • Specialists

In addition, the project needs a team of:

In clinical research, there is a place for every kind of talent. Advanced Clinical Research Project Manager Certification and Advanced Principal Investigator Physician Certification offer further specialized paths for advancement. For those interested in overseeing trial safety, consider the Medical Monitor Certification. Check here to see the positions open near you. For more details and training you can check ccrps.org

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