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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Clinical research is one of the best career path to get involved in. They have positions for every lifestyle and personality. However, a solid understanding of the rules and regulation of the field is critical for every professional in the field. In this article, we will talk about the GCP and how it should impact the way you approach clinical research.

About the GCP 

Good Clinical Practice (GCP) is an international standard provided by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). GCP enforces strict guidelines on ethical aspects of the clinical study.

Individuals who are aware of the significance of very good clinical practice guidelines and the role of the clinical research know the importance of online GCP programs.

Medical professionals who have successfully completed their clinical research training program can improve their expertise on regulatory authorities and approval specifications for the marketing of the healthcare products. This can make a big change in their work life. A good training program can help them improve their proficiency in the best use of medical data, databases and data evaluation. This will help them build proficiency in the communication, research and management, educational approaches, problem-solving and other things related to the clinical research.  

Make a better informed decision  

The salary is one of the main factors considered by people planing to choose a degree or certification program. Here, you can find the average clinical research salary in your area and decide on whether a career in the clinical research.

If you wish to become a certified clinical research professional, then you have to find out and join in the program specially designed for career.

Clinical research involves drug development as well as healthcare research. Experts in this profession engage in the patient-focused research and make use of every chance to be successful in the clinical research career.

CCRPS visitors learn about clinical research and are able to make an informed decision to join the best program for them. When you have questions, you can have instant assistance from the experienced and committed professionals. We ensure our students understand about everything associated with the clinical research degree program and use every opportunity to be successful in the clinical research sector.  

Improve your resume now with online clinical research certification or membership in clinical research societies.

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

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The clinical research is a ground breaking field in the world of medical advancement and as such, has a wide variety of professionals that are changing and channeling the drive.

We will be taking a look at one of the highest paying certified clinical research professionals, clinical research coordinator.

CLINICAL RESEARCH COORDINATOR

The clinical research coordinator is responsible for conducting trials as per the GCP guidelines under the supervision of the Principal Investigator (PI). Although the PI carries the overall responsibility for performing the trial, the CRC is the heart and soul of the clinical trial and that, ultimately, it is the CRC who carries ahead the research objectives and ensures the success of the clinical trial.

Having a certification in clinical research in other to become a clinical research coordinator is not compulsory, but certification enables one to show that they have met the necessary requirements and have gained job-relevant knowledge and skills. This distinction is very important to pharmaceutical companies and contract research organizations, who frequently hire clinical research staff.

EDUCATIONAL REQUIREMENTS

• High school diploma and 6,000 hours of experience.

• An associate degree in clinical research fields amd 4,500 hours of experience, or

• A Bachelor's, Master's, or Registered Nurse degree and 3,000 hours of clinical research experience.

You can come from a variety of medical sciences or health related fields, or from a nursing background as a RN. Courses offered in hospital and clinical related ethics, team management, and research methodologies will be especially valuable.

Who Will Hire Clinical Research Coordinators?

• Pharmaceutical Organizations

• Contract Research Organizations

• Universities

• Hospitals

SPECIALIZATIONS

They focus on the following;

1) Participating in preparation and management of research budgets and monetary disbursements.

2) Informing patients or caregivers about study aspects and outcomes to be expected.

3) Communicating with laboratories or investigators regarding laboratory findings.

4) Ordering drugs or devices necessary for study completion.

5) Directing the requisition, collection, labeling, storage, or shipment of specimens.

6) Arranging for research study sites and determine staff or equipment availability.

7) Reviewing scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.

SALARY

Clinical research coordinators have had a positive trend of pay for experience. Therefore a CRC with less than 5 years experience is paid an average total compensation of $43,000 (based on 1,237 salaries). Employees with 5 to 10 years experience can expect the average compensation of $51,000 (based on 429 salaries). Employees with 10 to 20 years of experience is paid an average compensation of $55,000 (based on 265 salaries). Finally, employees with more than 20 years of experience can expect a compensation of $62,000 (based on 52 salaries).

While many stay CRCs their entire career, most will move to higher postions after 3-5 years of experience. One of the most popular careers CRCs switch to is CRA, which can pay up to $300k.

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

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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. 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 to 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.

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

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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

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.

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.

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.

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

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Choosing the right job course online is a challenging task for almost everyone new to certification programs. There are so many different attention-grabbing packages of affordable clinical research programs, how do you know which one is for you? People who focus on the successful institution specializing in the clinical research programs are most likely to find a program they can truly learn and benefit from. Visit CCRPS, a major AACRE accredited U.S Organization,  and find courses provided by the certified clinical research professionals. You will get guidance about the programs in the clinical research that goes beyond your expectations. Their education will help you make a better-informed decision to choose and join in one of the best programs without complexity in any aspect.  

Job training for high school graduates

Future professionals with an ambition to choose and join the best courses should consider important things like the overall value of the course and how they contribute to career development. At CCRPS, we not only offer a description of what to expect in the field, we also offer real life suggestions from experts already working in clinical research.

Once you have joined our program, you can learn more than a few important things and enhance your career profile. You will get different career options and make positive changes in your career life. You will be satisfied with the successful method to prefer and join in the suitable job after a comprehensive analysis of an array of important things.  

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

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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

• 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:

• Clinical Research Associate (CRA) (click for certification course online)

• Clinical Research Coordinator (CRC) (click for certification course online)

• Biostatisticians

• Research site manager

• Research Auditors

• Quality Assurance specialists

• Marketing Executives

• Regulatory Affairs Manager

• Translators

• Lab staff

In clinical research, there is a place for every kind of talent. Check here to see the positions open near you. For more details and training you can check ccrps.org. 

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

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People wish to have the perfect platform to perfect their clinical research. As the clinical training program courses become more popular among people, in some cases there are people who simply choose clinical research training courses without knowing its roles and responsibilities.

When people decide to pursue clinical research course, there are several available ways, such as training programs from clinical research institutes or in online training programs.

Although there are many clinical research institutes, most prefer taking clinical research training programs to make their career stronger in the medical field. This is mainly because when people choose courses in clinical research institution or any research centers, it would costs $30,000 to $ 50,000 while online courses cost much less. 

Facilities provided in clinical research training in institutes:

You must be wondering how an online course might differ from a physical course. Online training courses are very similar to the courses offered in clinical research institutes. People can choose their desired specialization and attend daily sessions. Once they have completed all sessions and passed the course examination, they receive a course completion certificate.

Although the online clinical courses are similar to the courses offered in clinical research institutes, there are some facilities which are offered only in the clinical research institutes and research centers:

• In clinical training institute, students can experience clinical research operations with patients.

• Students are allowed to do test on various drugs and medicine, analysis them in traits test center.

• Based on the analysis test report, student can learn to decide whether the drugs are safe for market use or need to be sent for further analysis.

These facilities are only provided to people that choose clinical research courses from clinical research centers and institutes. These skills and experiences might be important to potential employers, so be sure to check the requirements on all job postings. For more details regarding this you can check on ccrps.org or visit us to learn more about our online clinical research certification programs.

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

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When students wish to have a strong career in the interesting medical field, they often become clinical researchers. The clinical researcher career is a popular choice because it brings several career as well as financial benefits. However, when you decide to choose clinical researcher as a career, then you should be aware of the roles and responsibilities involved in them.

Since there are so many available clinical research training programs, it is important that people know what roles and what specialization they want to go into. For example, when people complete their course or training programs from licensed centers, they could get clinical research organization jobs in pharmaceutical companies, medical research organizations, and in clinics. Although there are many courses available, people who knew going into training knowing exactly where they wanted to work would benefit more from their classes. You can start with a specific role by enrolling in the Clinical Research Coordinator course or explore specializations such as Pharmacovigilance Certification and CRA Training.

Due to the popularity of the field, those who get their Master’s in Clinical Research have an advantage. Their degree could get them better positions and pay than their counterparts. For those looking to solidify their knowledge of good clinical practices, the ICH-GCP course is essential.

Many people show an interest in completing their Master’s in Clinical Research, but in real life getting a Master’s in Clinical Research is not easy. In order to complete the course, people would need $30,000 to $50,000. Course from the top research centers would cost even more.

To tackle this situation, most people look to get their Master’s in Clinical Research online. Many wonder if online courses would be on par to trial centers training. The answer is that when students decide to do their Master’s in Clinical Research online, they find that the courses are very similar to classroom training.

Moreover, by taking online courses people can avoid several additional costs like travel, high tuition, and taking time off work. The only thing that is different is that in an online master’s course, people can’t experience hands-on training with patients, drugs, and medicines. This gap can be bridged by courses like Clinical Trials Assistant Training, which provide a comprehensive understanding of clinical trial processes.

When deciding to pursue an online masters, below are some other information you should consider:

There are many training centers that offer online Master’s in Clinical Research with low tuition fees. So people need to compare and choose the best among them.

Check whether the training center provides clinical research quality assurance training across all specializations. This speaks to the quality and comprehensiveness of the courses offered. Advanced courses like Advanced Clinical Research Project Manager Certification and Advanced Principal Investigator Physician Certification can be crucial for career advancement.

While comparing centers based on their courses, check whether the center would offer help with job placements too.

Before committing to anything, check jobs near you to see if an online course completion certificate is valid for the posting.

Thus based on all above factors, you can confidently choose the best clinical research training institute to pursue your Master’s in Clinical Research.

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

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Clinical research is a multidisciplinary, multinational and multi billion industry. Now days the pharmaceutical industries, one of the top employers for clinical research work, are becoming a fastest growing sector that boosts the economy of the clinical research to the rapid development. As compared to the previous years the clinical research field has undergone a remarkable evolution in the power, sophistication and scope on its methodologies. There is a remarkable change in the approach to the data analysis, data collection and experimental design where these are found to be the basis for the strong clinical research career. It is the next big thing that will create a wider scope of job opportunities in the field of life science.

Numerous advances topics and opportunities are cited in the clinical research graduate programs. This helps individuals learn about new developments in the field. The following are the some of the benefits of completing the graduate program in the field of clinical research. They are:

• When you complete the graduate program in the clinical research, you qualify for positions that have significantly better non financial and monetary benefits than other areas of the industry. 

• You will typically enjoy a high base salary and expect an annual bonus from the company. Depending on your position, the company will typically be providing the vehicle facility for personal usage too. 

• You will be also getting the food allowances and health insurance profits. The company will also be providing you the gadgets like a mobile phone, laptop and all in one printer for working from home/remote working.

When you have the knowledge and skills from the clinical research education program, you have the opportunity to work with other high skilled staffs as well as the perfect work and life balance. 

How to obtain a career in the field of clinical research

Clinical research is an expanding area of the work that is gradually generating the more interest for many people. Fortunately, there are countless opportunities in clinical research for the doctor of nursing practice and anyone can pursue a career in the field of the clinical research.

One of the most important benefit of pursuing a clinical research program is the wide range of jobs vacancies that are available in this field.  

Some of the typical tasks in clinical research is taking part in the development planning, project management, management and site selection, feasibility studies, development planning, and project management. In order to get into this clinical research profession it is important to have the degree in any of the following subjects like medicine, nursing, biology, immunology, dentistry, chemistry, and pharmacology. These fields are where most of the clinical roles and jobs are available. You can check here to check out positions available near you. For more details and training you can check ccrps.org. 

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

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The UC San Diego Altman Clinical and Translational Research Institute, better known as CTRI UCSD, acts as the hub for translational medicine. It helps in delivering the scientific breakthrough patient care through clinical trials.

They offer participants early access the treatments, which would one day re-define the standards of care. Every year, the clinical research volunteer program would enroll the participant with the hundreds of the clinical trials for promising the investigational drugs, devices and the treatments.

If you want to become part of a research institute like CTRI UCSD, clinical research education can help you.

• Become well versed in the field that you really like.

• Pave a way for you to shine and know about the field.

• Helps you to do more research work based on the type of the field that you have chosen.

Things that you want to know about clinical research 

The clinical research acts as the branch of the healthcare science. If you are interested in the field, doing the clinical research online training program that is associated up with clinical research associates (CRA), clinincal research coordinators (CRC), or clinical trial assistants (CTA) could be a great way to get started.

Different research training programs could vary based on the student locations, time and the learning demands.However, CCRPS’ self paced online modules is reliable and contain interactive tutoring sessions that promotes monitored competency. Classes provide the foundation that will help you break into the field.

The ccrps.org paves a way for you to get trained up in the clinical research. Before choosing it, you can go through all the reviews that are available to give you a better idea of our courses. To know more details about it you can gather the information for training in clinical research here.

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

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The average salary for clinical research professionals is $63,000, but there are lots of different clinical research professionals in the clinical research industry and we will be taking them one by one to see their differences in salaries.

Clinical Research Associate (CRA)

CRAs earn $63,030 annually on average. Most join as junior clinical research associates (CRAs). They learn the life cycle of a clinical trial, how to monitor the clinical trial activities at different stages, and everything about clinical data monitoring and management.

Clinical Research Coordinator (CRC)

CRCs earn $48,739 annually on average. The clinical research coordinator is responsible for conducting trials and carrying our research objectives. Most significantly, CRCs are usually engaged in vital duties for the PI, like taking care of the informed consent process and making sure that the site staff is in compliance with the protocol. The CRC’s main responsibility, as with all clinical research staff, is to ensure the protection and well-being of the patients participating in the study.

Senior Clinical Research Associate (CRA)

SCRAs earn $97,813 annually on average. The senior CRAs deal with more complex clinical trials and site management issues than junior CRAs. They are there to highlight the importance of international research as well as the role of the ICH GCP process. They also give updates on the overview of current legislative requirements, including guidance on substantial trial modifications, improving the recruitment process of subjects and site staff, as well as how to prioritize and upgrade clinical trial monitoring tasks and activities, accurate monitoring and reporting.

Biostatistician

Biostatisticians earn $70,732 annually on average. They are involved in every step of clinical research, including trial design, protocol development, data management, and monitoring, data analysis and clinical trial reporting. They are also involved in data management protocol development and design study implementation data analysis and reporting and study monitoring.

Clinical Project Manager

CPMs earn $84,048 annually on average. The job of a CPM includes planning and managing all aspects of a clinical trial. In order to conduct a clinical trial adequately, CPMs manage a team of CRAs and Clinical Specialists and act as a link between the study sponsor and the clinical trial site.

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

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For a career in clinical research quality assurance, understanding internal, national and international regulations in every aspect of clinical development is absolutely essential. Legal setbacks can be dangerous for patients, extremely costly, and highly damaging to a company’s reputation. Therefore, the role of the Good Clinical Practice QA professional is a high profile one and can offer excellent opportunities for development. However, it can be a tricky area to get into.

Just as in clinical operations, as your QA career develops you will normally become more office based; seeing to the work of audit teams, developing audit strategies and plans and ensuring a culture of compliance in your own organization as well as the ones you’re in partnership with.

You will also gain exposure to other areas of QA, such as Good Pharmacovigilance Practice (GPvP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). Experience in more than one QA specialization will make you more attractive to potential employers. For instance, GPvP experience is particularly sought after these days.

Many people choose to go down the interim path as their QA careers develop, opting for either short-term, ad-hoc work to complete individual projects for a range of clients or to take longer-term contracts that offer more security but at a lower pay rate.

The right personality is crucial to success in the QA world. Thankfully the days of QA groups being seen as ‘other’ in most companies are long gone.

You will be expected to train staff from a wide variety of disciplines, answer QA related queries and, on occasion, deal with some difficult situations. Very strong interpersonal and communications skills, a high degree of tact and knowledge in different areas is essential to the job.

HOW MUCH DOES A CLINICAL QUALITY ASSURANCE MANAGER MAKE?

The national average salary for a Clinical Quality Assurance Manager is $98,393. Salary estimates are based on 4,654 salaries submitted anonymously by clinical quality assurance manager employees.

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

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Research project managers (PMs) are responsible for leading research projects to a defined business or scientific objective. To reach this goal, research project managers utilize different methodologies and techniques for managing and guiding the development of research instruments. They are also in charge of evaluating research related fieldwork, validating collected data, authoring reports and communicating across various research constituencies.    

What responsibilities does a clinical project manager job have?

CPM jobs involve planning and managing all aspects of a clinical trial. The aim of clinical trials is to evaluate the safety and effectiveness of pharmaceuticals, medical devices, or in-vitro diagnostic devices to support regulatory submissions or marketing claims.

In order to manage a clinical trial adequately, CPMs manage a team of CRAs and Clinical Specialists. They also act as a link between the study sponsor and the clinical trial site. As a CPM, it is important to understand project management methodologies. They will allow you to effectively lead a cross-functional team.

Analytical and writing skills are also very important, because a CPM job will involve developing documents such as protocols, informed consent documents, contracts, and grants. A skilled CPM should also be familiar with the financial aspects of a clinical study, including reviewing invoices, performing daily accounting tasks, and preparing budgets. Sometimes, clinical research manager jobs may include contributing to the statistical analysis and data reporting documentation used to support a marketing clearance, approval or registration.

How much do CPMs earn?

The average clinical research manager salary is $75,474 in the United States.

What is the demand for CPMs?

Demand for CPMs increases, as there are increased global regulations requiring more extensive clinical studies to support the safety and effectiveness claims of health-care products. CPMs may work for pharmaceutical, medical device, or in-vitro diagnostic device companies. CPMs may also work for contract research organizations (CROs)- an organization that is hired to outsource clinical trials or perform other clinical research support.  

What qualifications or training do I need as a CPM?

CPM can come from different educational backgrounds and fields. Most have, at a minimum, a bachelor’s degree in a sciences field such as biology, health, life sciences or bioengineering. Those with advanced degrees such as MS, MBA, Ph.D. or MD will find it easier and faster to reach the CPM position, as long as they have relevant clinical trial and project management experience.

As a CPM, you will be working in a highly regulated environment and should have an expert understanding of Good Clinical Practice and other relevant regulatory requirements. You should also have exposure working with institutional review boards (IRBs) or ethics committees (ECs).

Generally, a principle CRA with about 7-9 years of experience would be a strong candidate for a CPM position. A position as a clinical team lead, clinical team manager, or clinical operation leader would also serve as an excellent transition towards becoming a CPM. These positions offer valuable clinical leadership and management experience without some financial management responsibilities, such as budgeting.   

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

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International Clinical Trials Registry Platform (ICTRP)

The International Clinical Trials Registry Platform (ICTRP) has a strong internship program which welcomes interested and enthusiastic students, professionals, and researchers from a wide range of disciplines. Internships with the ICTRP are flexible and tailored to individual learning goals to provide interns with the best possible experience with the ICTRP at the World Health Organization.

Internships with the ICTRP provide an excellent opportunity to participate in the work of health policy related to clinical trials, research transparency, and knowledge sharing.

Internships with the ICTRP

Yale University – New Haven, CT

An internship that provides an opportunity to develop professional skills in a wide variety of fields and to support various university initiatives. Observes and gains expertise in applicable areas. Assists and completes various projects, programs, and assignments.

Essential Duties:

1. Working with and shadowing senior clinical research faculty in clinical research Human subject protection and regulatory training

2. Meeting regularly with faculty and receive mentoring

3. Working with regulatory and subject recruitment units

4. Rotations in inpatient and outpatient research clinics

Yale Center for Clinical Investigation Internship Program

Vanderbilt School of Medicine - Nashville, TN

The Vanderbilt Undergraduate Clinical Research Internship Program (UCRIP) offers college students earning a four-year degree the opportunity in research and clinical patient care at the academic medical center. This program is designed for students who are interested in a career in medicine.

Participants will design and complete research project from June to July, presenting results at the end of the program. The project may be in clinical or bench science research. Participants will be placed under the directorship of a research mentor. In addition, they will be spending time with residents and attending physicians.

Undergraduate Clinical Research Internship Program

NYU Langone Health - NYC, NY

This program is open to undergradute as well as post-baccalaureate students. The program is created by the Ronald O. Perelman Department of Emergency Medicine and consists of clinical and non-clinical research shifts based in the Emergency Department.

RA interns will:

1. develop basic research skills

2. be taught how to collect and enter data, and maintain databases

3. participate in laboratory meetings

4. gain Principal Investigator mentor-ship and/or shadowing experiences

5. RA interns will also become oriented to the Institutional Review Board and other Human Subjects courses

Research Associate Internship

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WHAT IS A CLINICAL RESEARCH STUDY?

A clinical study is medical or drug research that involves research using human volunteers (also called participants). There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies.

Here’s a selection of the top clinical research blogs that will help you stay up-to-date with the latest industry trends, topics, and research breakthroughs:

• PLACEBO CONTROL.

Improving patient recruitment methods through the interpretation of actual clinical trial data is the then goal of Placebo Control, as you continue to read the posts in Placebo Control, you’re enlightened by Paul’s ideas, insights, and possibilities that could potentially reshape the industry.

• EYE FOR PHARMA

I think the main thing that makes this blog unique is receiving direct insights from industry executives themselves. You’ll also see a lot of commentaries, reports, and arguments from experts

• THE CLINICAL TRIAL GURU

A blog that’s strictly professional. Dan Sfera originally started this blog to attract study participants for his research. What happened instead was totally unexpected. Surprisingly, Dan received a lot of comments and inquiries from clinical professionals instead of patients. Today, the blog caters to clinical professionals, and tips on how to survive the industry.

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Informatics is a branch of information science, which is a broad and interdisciplinary science that deals with the gathering, classification, storage, manipulation, retrieval and analysis of data as an organized resource; and of computer science that focuses on the study of information processing, particularly with respect to systems integration and human interactions with machine and data.

Clinical research informatics involves the use of informatics in the discovery and management of new knowledge regarding health and diseases. It includes the managing of clinical research information and deals with the secondary use of clinical research data.

Healthcare informatics is divided into two primary domains: translational bioinformatics and clinical research informatics.

Clinical research informatics provides clinical researchers with huge sums of information about trials that have been carried out over the years. This helps cut costs that come with developing new medications. For example, at the beginning of each clinical research, clinical research informatics helps you estimate how many patients you will be able to get, and how many are likely to drop out. All this data helps increase the likelihood of better outcomes and optimizes the study design before it has begun.

All biomedical informatics that is focused on clinical research is called clinical research informatics, which is a venture that is growing at a rapid pace and has ensured that significant improvements were seen in the efficiency and quality of clinical researches around the world.

We cannot overemphasize the critical importance of clinical research in the advancement of clinical sciences, public health, and medical sciences. Conducting clinical research is a resource intensive and complex operation that involves numerous procedures, processes, professionals, workflows, and information resources.

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Clinical research regulations are set in place to make sure that all clinical research projects are conducted in accordance with international principles. The following regulations are the basics of the clinical research profession, and good for any aspiring professionals to know.

Good Manufacturing Practice (GMP)

This regulation is set in place to ensure that manufactures investigational medications and products to be safe and meet standards. This ensures that all participants involved in the clinical trials are not exposed to poor, harmful, and ineffective drugs.

Good Clinical Practice (GCP)

Good clinical practice is a major regulation that is set in place to conduct all clinical trials in accordance with the internationally recognized principles of the ICH GCP. It is there to ensure that risks to patients and volunteers are minimized.

Good Clinical Practice and Good Manufacturing Practice inspections and Enforcement

The MHRA checks the principles and standards of the GMP and GCP to ensure quality and that compliance are followed. They also help identify non-compliance and provide enforcement power.

Incapacitated Adult's Protection

This regulation is set in place to protect adults that are incapable of giving informed consent (e.g advanced Alzheimer's disease). The decision to consent to, refuse, or participate in a trial is made by an independent "consultee" that would act on the basis of the incapacitated adult wishes.

Minor's Protection

This regulation is set in place to protect minors (persons under the age of 16) and ensure that the following before a minor’s participation in trials:

• REC consideration of receiving advice on the pediatric care relevant field.

• A parent, custodian, guardian, or legal representative must give informed consent.

• The minor should be informed of the risks and benefits of the trial according to their understanding capacity by staff experienced with young people.

• The minor's wishes to be withdrawn from the trial or refusal to participate from the trial should be considered.

• The clinical trial must be directly related to the illnesses the minor suffers from.

• The clinical trial must directly benefit the minor involved.

Pharmacovigilance Arrangements

This regulation takes into account all the clinical trials of an IMP. It ensures that the reviews of adverse events and processing of serious adverse events are reported immediately to sponsors. In addition, it mandates that there must be a record of suspected unexpected serious adverse reactions caused by the trial medicines and that they must be reported to the MHRA.

If you want to learn more about the regulations of clinical research, take our free ICH GCP course. This course will help you build the knowledge for a solid foundation for a career in clinical research.

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Clinical researches are carried out in four phases to ensure consistency and accuracy.

Let's go through the four phases of clinical research.

• Phase 1: Phase 1 starts with the first clinical trials performed on people. This phase immediately follows the preclinical research assessment of tests and treatments on animals. This shows how a drug is processed in the human body and its effects. A very small dose is administered to a group of 10 - 15 people.

• Phase 2: This phase is tested out on a larger, yet still small group of 15 - 30 people. Low doses are given before they are increased till side effects become too severe or the desired effect is seen. Phase 2 tests the safety of the drugs before it can be moved to the next phase.

• Phase 3: This phase further assesses the safety and effectiveness of the drug. This time it is administered to 100 - 300 patients. New combination of treatment and drugs are tested and if found to effective, the new drugs are compared to the standard of care drug. They are compared to ascertain which drug works better. The trials are randomized. Patients are randomly placed into groups and tested with different treatments. This phase is quite important as it helps and provides the necessary information needed for the FDA to approve the new drug to be used in the general public.

• Phase 4: This final phase tests the newly FDA approved the drug in several hundred or thousands of patients. This enables better research and identification of short-lived and long-lasting side effects of the drugs.

Generally, Phase 1 is the earliest phase of clinical research, but sometimes clinical researchers or clinical professionals might need you to join a phase 0 study. Phase 0 studies are aimed at finding out if a drug behaves the way it did in the laboratory studies. Phase 0 studies involve a small number of people (10 - 20) who are given a very small dose of the drug. The dose of the drug is so little that the chances of having any side effects are of the most minimal.

All these phrases are performed by clinical research scientists. They perform medical research for the main purpose of improving human health. They design studies on the investigation of particular diseases, the development of the medical device, and the evaluation of a drug's safety or effectiveness. They are also responsible for getting the funding for their experiments by periodically writing for grants and proposals for submission to governmental agencies and private organizations. Clinical research scientist can work anywhere, be it in the university, private organizations, hospitals, and research institutions.

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A clinical research pharmacist is involved in many roles. They're a position that is still expanding in the clinical research industry. Clinical research pharmacist helps establish the effectiveness and safety of new medicine, drug, treatments, or new procedures of using old ones. They also formulate the new drugs or treatment and they package and label the drugs or new treatments. They also carefully monitor those who receive the new drugs for adverse effects or other unexpected outcomes.

Becoming a clinical research pharmacist entails working on new ideas about the ways in which clinical research studies can be carried out. In trials, they need to ensure that good clinical practices are in place as well as the enforcement of regulatory requirements.

There's a whole world of options for clinical research pharmacist as they work in various roles, for example they can work in pharmaceutical industries or trial units. They tend to work with a wide variety of other clinical research professionals during the course of clinical trials, especially those in research and development (R&D). During the research and development phase, they will work with clinical research project managers, clinical research associates, as well as research nurses and individuals involved in the clinical trials: from pharmaceutical companies to funding agencies.

Clinical research pharmacists look into the resolution of a range of problems that may arise in the course of a clinical research study. There are basically five main scopes of clinical research that clinical research pharmacist is primarily involved in. They include:

• Clinical trials coordination.

• Clinical trials.

• Research and Development.

• Funding.

• Formulation, packaging, and marketing.

Being a clinical research pharmacist is not a easy job, but it can be rewarding emotionally and financially for the right person. The median salary for a clinical research pharmacist is $130,000. Click here for a listing of positions near you.

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