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. Enhance your understanding and skills with an ICH-GCP course.

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. Consider enrolling in a Pharmacovigilance Certification to enhance your credentials in this area.

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. Expand your capability with Clinical Research Coordinator training or a Clinical Trials Assistant Training course.

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. Specialized certifications like the Advanced Clinical Research Project Manager Certification or the Advanced Principal Investigator Physician Certification can propel your career forward.

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Also, check out the CRA course for further qualifications, and the Medical Monitor Certification to explore other high-demand roles in clinical research.

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, like those taught in the Advanced Clinical Research Project Manager Certification. 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 (ICH-GCP) 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

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

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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.

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

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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. Enhance your skills in monitoring drug safety with our Pharmacovigilance Certification.

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. Start your journey in clinical trials with our Clinical Trials Assistant Training.

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. Gain comprehensive knowledge in ICH-GCP standards with our ICH-GCP course.

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. Learn more about becoming a proficient Clinical Research Coordinator with our Clinical Research Coordinator course. Master the skills needed to lead clinical studies with our Advanced Principal Investigator Physician Certification.

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

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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. For those interested in further enhancing their knowledge and skills in this area, consider enrolling in the Advanced Clinical Research Project Manager Certification course.

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. If you are looking to build a foundation in this critical area, our ICH GCP course can be an excellent resource.

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. To learn more about roles in this regulatory field, explore our Medical Monitor Certification course.

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. Enhance your understanding of such roles with the Advanced Principal Investigator Physician Certification.

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.

To delve deeper into regulations protecting minors and their application in clinical trials, our Clinical Trials Assistant Training provides comprehensive insights.

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. For those interested in specializing in this critical aspect of clinical trials, consider our Pharmacovigilance Certification.

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.

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

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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. To learn more about the roles and responsibilities during this initial phase, consider enrolling in the Clinical Trials Assistant Training course.

• 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. For those interested in further exploring drug safety and its monitoring, the Pharmacovigilance Certification might be of interest.

• 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. Aspiring Clinical Research Coordinators can deepen their understanding by taking the Clinical Research Coordinator course.

• 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. For professionals interested in leading clinical trials, the Advanced Clinical Research Project Manager Certification offers extensive training.

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. For physicians aiming to become principal investigators, the Advanced Principal Investigator Physician Certification and for those looking to specialize in medical monitoring, the Medical Monitor Certification are valuable resources.

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

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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.

For those looking to delve deeper into this vital role, consider the Clinical Research Coordinator course which provides essential training on managing clinical trials.

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. For a comprehensive understanding of these practices, the ICH-GCP course is highly recommended.

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. If you are interested in these roles, consider exploring the CRA course or the Advanced Clinical Research Project Manager Certification.

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.

For those interested in assisting in clinical trials, the Clinical Trials Assistant Training offers targeted education in this area.

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.

For those aiming to reach a higher level in this field, such as becoming a principal investigator or a medical monitor, the Advanced Principal Investigator Physician Certification or the Medical Monitor Certification might be the next steps.

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

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

When it comes to clinical research jobs for pre-med students, they are a bit hard to find. Luckily enough, we've got you covered. There are several pre-med jobs that are available to help you gain clinical research experience before you've completed your bachelor's degree. And yes, they are paying jobs.

These jobs will help showcase your interest and competence for any graduate program of your choice; be it dental school, physician assistant (PA), pharmacy, occupational therapy, medical school, or physical therapy (PT).

Emergency Medical Technicians

EMTs work for the emergency department or ambulance service in hospitals. They are specifically trained to manage and assess common medical emergencies from accidents and illnesses. They assist the nurses and doctors in the treatments of patients in the emergency rooms. Training requires 120 - 150 hours of instructions within 3 - 11 weeks. Consider advancing your skills with Advanced Clinical Research Project Manager Certification to further enhance your capabilities in clinical settings.

Phlebotomist

Phlebotomists work in blood banks and clinical research labs. They are trained in drawing blood from patients and are expected to complete 200 hours of instructions. To expand your career in clinical research, explore the Clinical Research Coordinator and Clinical Trials Assistant Training courses.

Certified Nursing Assistants

CNAs work in nursing homes, rehabilitation facilities, and hospitals. They help in assisting the nursing staff with acute care and long-term care. They are trained on how to control infections, and assists patients or residents with their daily routine. CNAs are in really high demand and the best way to become one is to have CNA experience, get certified through 4 - 15 weeks programs, and pass a state exam.

Dental Assistants

Dental Assistants work in dental offices. They are trained to maintain patient records, take x-rays, and provide patient care. They do not require certification. All you need to do is go through some formal training programs in dental offices.

Medical Scribes

Medical scribes work with physicians personally during patient visits and help documents all important information into the Electronic Health Record (EHR) of the patient. They are trained to organize information and understand medical terminologies. Enhance your understanding of good clinical practices with the ICH-GCP course.

Pharmacy Technicians

They work in clinical and retail pharmacies. They are there to assist the pharmacist with any technical tasks. The job prepares you for a career in pharmacy. Explore our Pharmacovigilance Certification to learn about ensuring the safety and efficacy of pharmaceutical products.

Even though you are a pre-med means, there are several salary earning pre-med jobs you can choose from. Make a wise choice today, join the CCRP community and let us help you build your career.

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

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a clinical research degree makes you competent enough to function in the field of determining the safety, effectiveness, and efficacy of medical devices, new drugs, new treatments, and pharmaceutical products. There is no shortage of work for clinical research professionals as long as they have their degree at hand. The field is also a booming industry that is looking to raise the roof of medical advancement with competent certified clinical research professionals.

Government agencies like the FDA and many private companies are on the lookout for clinical researchers and managers that will monitor new treatment, medicines, and diagnostic products that are hitting the healthcare market every day.

Clinical research degrees include the following:

• The expertise and involvement in the clinical field must be determined by the membership in the Consortium of academic programs in clinical research.

• They must be the accessibility to students which be determined by the academic and professional experience required for admission.

• Career training and curriculum relevance must be determined by the balance of technical and managerial coursework.

• The application of knowledge type of experiential learning the requirements to graduate and significance to graduate must be instilled in the curriculum.

Students seeking a clinical research master's degree are sometimes already employed in the healthcare industry. The clinical research managers master's degree program offers plenty of flexibility in scheduling including online, offline, or hybrid course options.

For example, the University of Texas at Rio Grande Valley offers clinical research laboratory and hospital workers a convenient and affordable clinical research management master's degree program that is accelerated to be completed within 12 months. Its tuition is $1,008 per year. It is a top choice for working clinical research professionals who need to earn a paycheck while building their credentials. However, their accredited MS in clinical research is designed only for MDs.

On the other hand, the University of Texas Health Science Center at Houston is designed for clinicians and MD's at the faculty and fellow level. Its accredited MS in clinical research is a tough one that calls for a minimum of two years of courses delivered in weekly 90-minute lectures. Lectures are divided into the study design of clinical research, and emphatic genetics and molecular biology of translational research. Its tuition is $17,318 per year.

Degrees for clinical research sometimes has extreme strict admission requirements. So, it is important that each applicant consider each of their options carefully and choose the one that suits their needs and background best.

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

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A clinical research scientist performs medical research for the main purpose of improving health in animals or humans. They designed studies that involve

• the investigation of particular diseases

• the development of a medical device

• the evaluation of a drug's safety or effectiveness

Scientists get 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 a university, private organizations, hospitals, or research institutions.

To be a clinical research scientist and to start earning $95,420 as median salary yearly, you need a minimum degree level of a master’s degree and sometimes a Ph.D. in biological sciences, or medicine.A license is rarely required but many get the optional certification from the Association of Clinical Research Professionals. A work experience of two to five years, and the following key skills are what appeals the most to employers:

• The ability to use analytical, scientific, graphics software, and user interface.

• Extensive knowledge of computer processors, chips, hardware, and circuit boards.

• Knowledge of other electronics and electrical equipment.

• Knowledge on the usage of laboratory flasks, centrifuges, Petri plates or dishes and many more specifics.

The minimum degree required for a clinical research scientist is bachelor’s, but many get a MD or a Ph.D in Biology. They perform key responsibilities like the publication of research laboratory research and analysis for medical innovations. No license is required if the tests are going to be carried out on animals. However, but if you going to be conducting medical procedures in humans then all states require medical licensing. According to the United States Bureau of labor statistics, the average salary for a clinical medical scientist is $93,730. This ranks it as one of the highest paying clinical research professionals jobs in the clinical research industry.

If you want to stand out, you need go for a doctor of medicine degree or a doctorate’s degree in natural sciences. For you to gain a medical degree, you will have to undergo an admission process by submitting your scores from the medical college admission test (MCAT), letters of recommendation, and copies of all undergraduate transcripts.

The doctor of medicine MD degree spans for 4 years and during this. you will go through a wide range of courses which includes; anatomy, psychiatry, and pathology. Also you'll have to spend a lot of time in the laboratory setting and clinical settings.

A doctorate degree program must sit for departmental oral and written examinations. Many medical schools offer a joint MD and Ph.D. program that last 7 - 8 years. These programs offer a fast-tracked medical and scientific education that specifically cater to the clinical research field.

A clinical research scientist can work in public and private institutions. Job prospects show that there is going to be an 8% increase from 2014 to 2024. Scientists with both credentials have the best job prospects. Check here for some positions near you.

Expand your expertise in this field by exploring courses offered by CCRPS:

• Clinical Research Coordinator

• Pharmacovigilance Certification

• CRA Certification

• ICH-GCP Training

• Clinical Trials Assistant Training

• Advanced Clinical Research Project Manager Certification

• Advanced Principal Investigator Physician Certification

• Medical Monitor Certification

These programs are designed to provide you with the necessary skills and certifications to excel in the field of clinical research, enhancing your job prospects and preparing you for a variety of specialized roles within clinical research institutions.

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

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The clinical research industry has a lot of acronyms. It can be very confusing to navigate through the field’s vocabulary, especially if you are just starting to read about it. Below, I will tell you everything you need to know about CROs and make your life just a little bit easier.

What is a CRO?

CRO, or a clinical research organization, is a company that assist drug manufacturers and pharmaceutical companies by outsourcing the necessary stages and clinical trial processes. CROs streamline clinical trial processes and help in research and development (R&D). To better understand the roles within a CRO, consider exploring the Clinical Research Coordinator course or the Clinical Trials Assistant Training.

What is the outlook for CROs?

The CROs are critical to the R&D process, and they create growing field. In 2017, the pharmaceutical outsourcing market was valued at $3.37 billion. By 2024, it is estimated to become valued at $7.26 billion.

Many large companies have their own clinical research organization or rely on an outside company to conduct drug development and testing. Outsourcing these services save pharmaceutical companies a lot of money. By hiring a CROs, companies no longer have to recruit or maintain their own clinical department. This helps a company cut down costs overtime.

The two major CROs are the LabCorp and IQVIA.

LabCorp, or Laboratory Corporation of America Holdings, generated $11.5 billion of revenue in 2019. LabCorp is split into two: Covance Drug Development and LabCorp Diagnostics. One focuses on clinical research from the early stage research to post regulatory approval, while the other focuses on the diagnostic tests.

IQVIA was the result of a merger between IMS Health and Quintiles in 2016. It had made $11.09 billion in revenue in 2019.

Why are CROs Growing?

Before a drug or medical device can be sold to the public, they must be approved by the relevant bodies. For example, in the U.S., a new drug must be FDA approved before it is released on the market. However, most evaluating bodies have high requirements and need a lot of quality, positive data approving a product. When companies expect unbiased and high-quality results, they hire a CRO.

CROs are experts at what they do. They provide skilled personnel to generate high-quality data and assist with the necessary paperwork so that an approval can go through. One of the most compelling reasons to hire a CRO is that they are unbiased. CROs work closely with the companies they work for, but are separate from them. They do not share a conflicts of interest and can be trusted to report accurate and truthful data.

Want to work for a CRO?

CROs are a part of a growing field, and they need a lot of manpower. There are so many postings for positions within a CROs right here. Don’t have any experience? Don’t worry! You can take courses from CCRPS and learn how to become a clinical research professional. Explore specialized courses like Pharmacovigilance Certification, CRA Training, ICH-GCP Training, Advanced Clinical Research Project Manager Certification, or Advanced Principal Investigator Physician Certification to further your understanding and skills in the field.

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

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Clinical research trials require a variety of people working together to execute a proper trial. There are several different career paths in clinical research, from technical positions to administrative positions.

Clinical Research Associate (CRA), Field Monitor, Clinical Monitor or Trial Monitor

The clinical research associate supervisors and monitors are requested and paid by sponsors who hire them to help with the administrative parts of clinical trials. Their duties include the filing of data, reviewing of case reports, performing investigational product accountability, and making sure that all necessary items are properly filed and documented. They also assist with pharmaceutical research, devices research, and biologics research. They ensure that good clinical practices are followed and that protocols are observed. For those interested in becoming a Clinical Research Associate, detailed training can be found here.

Clinical Research Data Manager

Clinical research data managers are in charge of the systems that produce data. Data managers review the protocol for trials before they start. They go through all the data involved in clinical trials strategically and analytically. They also review regulations, prepare protocols, and help the senior manager to ensure that the clinical trials are carried on smoothly. They are in charge of the monitoring, documentation, and information of all research studies. Learn how to manage clinical research data with our Clinical Trials Assistant Training.

Clinical Research Scientist

The clinical research scientist conducts clinical research trial roles that require years of working on clinical trials and clinical trial sites. They conduct a scientific test and ensure that there is proper monitoring of clinical research. They are also familiar with submission processes of clinical research studies, drawing up regulation affairs frameworks, assessment of study, and so on. To dive deeper into this role, consider our Advanced Clinical Research Project Manager Certification.

Biostatistician

The biostatistician operate when there is a compilation of clinical research data. The biostatistician sets up parameters for data collection clinical research products use to fulfill certain criteria. They also analyze all the clinical trial data and come up with a documented report that contains the results. Enhance your skills in biostatistics with our Medical Monitor Certification.

These clinical research positions above are regarded as some of the highest and high paying clinical research professionals positions in the world right now.

What are you waiting for? Register for courses get certified and start practicing.

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

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Clinical Research training is a prerequisite for all certification as clinical research professionals. Clinical research training is committed to providing support to facilitate the highest possible quality in clinical research. CCRPs provides training opportunities for faculty and research staff to ensure that research is carried out efficiently and appropriately. It also takes into account the safety of Clinical research.

The clinical research training program includes professional development for the whole clinical research faculty, this includes; clinical research nurses, clinical research coordinators, clinical research data managers, clinical research regulatory officers, clinical research administrative officers, and clinical research financial staff. The training is for anyone who is a clinical research professional or is involved in clinical research.

Clinical research training can be done online or in institutions, and it is done to maintain broad-based information on the local state federal and institutional requirements that are needed to initiate and manage clinical research. It includes detailed knowledge about the specifics of implementing research concrete system for educating and updating those involved in clinical, translational research and also observational research about the compliance and regulatory requirements and procedures of the clinical research. The training program is also designed to help educate research staff on how to resolve problems encountered in their work environment.

Courses are open to all faculty and clinical research staff including the support staff. They include the following;

• Good clinical practice training (ICH-GCP) also is known as GCP. GCP is very important as sponsors and are asking of it before initiating trials. GCP training twice a year and it's done face-to-face with experience, competent, and qualified GCP instructors

• Introduction to a clinical trial. Although we at CCRPS do not offer clinical trials it is a prerequisite to understanding clinical research procedures.

CCRPs offers the lowest fees for online courses there are over 110 courses to choose from and all of them are for a little fee per year. With the online clinical research training from CCRPS, you can go on to establish a name for yourself in the clinical research industry. Clinical research managers and clinical research Associates (CRA) are the hotcakes in the clinical research industry presently. They are by far the most wanted clinical research professionals earning on an average nothing less than $55000 at least and over $120,000 per annum.

Make the smart choice today, switch to CCRPS take the online courses and upgrade your career.

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

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

Looking at 2018, there are several shifts in clinical trial outsourcing trends that sponsors and vendors should be aware of. Many of these trends are driven by regulations and industry guidelines, as well as a growing need for new therapies.

In 2017, there was a slight increase in clinical outsourcing penetration as it grew from 43 percent to 45 percent (Clinical Leader). While the majority of outsourcing still lies with large, full service CROs, the percentage of work going to specialist CROs is growing due to a need for experts in therapeutic areas and indications, regulatory requirements and pharmacovigilance.

Below is a look at trends in outsourcing that shaped 2024:

TECHNOLOGY INVOLVEMENT

Sure, technology has been an ongoing trend in clinical trials for years. Technologies such as Electronic Data Capture (EDC), Patient Recorded Outcomes (PRO) and Clinical Trial Management Systems (CTMS) have become part of the norm. However technology is now playing a bigger role in the overall clinical study strategy. Tech giants such as Google, Amazon, and Apple are also looking for a chunk of the clinical trial sector by developing technologies that are patient-centric. Market leaders such as Medidata, Oracle and Veeva are continuing to develop extensive technology platforms for clinical trials.

DATA ANALYTICS ARE FUNDAMENTAL

Centralized statistical monitoring is being mentioned more frequently as sponsors look to facilitate risk-based monitoring with real-time, accurate metrics. Data analytics will play an even greater role in crucial strategic decisions for Sponsors.

PHARMACOVIGILANCE OUTSOURCING (PVO) ON THE RISE

Pharmacovigilance outsourcing got its own acronym and some additional attention in 2018. The management and reporting of adverse events is becoming a complex business and new regulations are making it more difficult for sponsors to keep up without support from specialized experts. Enhance your expertise with a Pharmacovigilance Certification.

BIOTECH GOING AT IT ALONE?

Biotechs have often looked to large pharma partnerships to carry their compounds into late phase trials and on to approval. Biotechs now have multiple outsourcing models available including Functional Service Provision to allow them to continue developing their product.

RISE OF STRATEGIC PARTNERSHIP MODEL AND FSP

Over 60 percent of Sponsors have started outsourcing in-house activities to “strategic partners”. For clinical, data, regulatory and clinical IT solutions, Sponsors are increasingly looking to the Functional Service Provision model.

Whether you’re considering a career in clinical research management or looking for a job in that field, here’s a round-up of the info you need to know. Advance your career with specialized certifications like Advanced Clinical Research Project Manager, Advanced Principal Investigator Physician, or Medical Monitor.

The average pay for a Clinical Research Manager is $32.27 per hour. The average pay for a Clinical Research Manager is $77,532 per year. Is Clinical Research Manager your job title? Get a personalized salary report!

Where is a Clinical Research Manager likely to work?

• A Clinical Research Manager can work for a number of different and exciting organizations, including a:

• Pharmaceutical company

• Government-based organization – the Medicines and Healthcare products Regulatory Agency (MHRA)

• A non-governmental organisation (NGO) – World Health Organization (WHO)

• Health charity

Take a look at latest vacancies in clinical research today!

Begin your career with comprehensive training as a Clinical Research Coordinator, CRA, or Clinical Trials Assistant.

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

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A medical laboratory or clinical laboratory is a laboratory where clinical pathology tests are carried out on clinical specimens to obtain information about the health of a patient to aid in the diagnosis, treatment, and prevention of disease. Medical laboratories vary in size and complexity. They also offer different testing services.

Eurofins Clinical Research Laboratories (CRL) was established in 1992. Today, CRL operates as a contract laboratory providing a wide range of clinical safety and efficacy testing. Located in central New Jersey, CRL is dedicated to conducting human clinical test procedures to determine the safety and efficacy of cosmetic, personal care, and OTC drug products.

One of CRL’s specialties is providing human repeated insult patch testing (HRIPT) as both shared and exclusive panels. Various safety-in-use (SIU) studies are provided to meet the needs of any specific product category. There are different safety tests that CRL provides which can be modified to meet new and emerging technologies.

The staff of clinical laboratories may include:

Pathologist.

Clinical Biochemist.

Pathologists' Assistant (PA).

Biomedical Scientist (BMS) in the UK, Medical Laboratory Scientist (MT, MLS or CLS) in the US or Medical Laboratory Technologist in Canada.

Medical Laboratory Technician/Clinical Laboratory Technician (MLT or CLT in the US).

Medical Laboratory Assistant (MLA).

Phlebotomist (PBT).

Histotechnologist/Histology Technician.

What is a Clinical Laboratory Scientist?

The average pay for a Clinical Laboratory Scientist is $30.99 per hour.

Clinical laboratory scientists generally work for hospitals and independent medical laboratories. Candidates for this position are generally required to have a bachelor’s degree in biology, chemistry, laboratory science, or a related field, as well as necessary certifications as required by employers.

Eurofin CRL is a huge employer of clinical laboratory staff. If you are on the look out for a career in clinical research, check out their website here.

Additionally, for those interested in expanding their qualifications, consider the Advanced Clinical Research Project Manager Certification or the Advanced Principal Investigator Physician Certification offered by CCRPS to further your professional development.

Take courses from CCRPS and learn more on how to become a clinical research professional. Enhance your career by exploring specialized roles through comprehensive training like the Clinical Research Coordinator, Pharmacovigilance Certification, CRA Certification, ICH-GCP Training, and the Clinical Trials Assistant Training. These courses are designed to equip you with the necessary skills and certifications to excel in the field of clinical research.

For those involved in medical monitoring, the Medical Monitor Certification is a crucial resource for staying current with industry standards and regulatory requirements, ensuring that safety and efficacy tests align with professional expectations.

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Clinical psychology research is a specialization within clinical research. It is the study of behavioral and mental health. In many ways, it is as important to the nation's health and well being as medical research.

In the same way that medical scientists work to understand the prevention, genesis, and spread of various diseases, clinical research psychologists conduct rigorous psychological research studies to understand, prevent, and treat the psychological conditions as it applies to individuals, couples, families, cultures, and diverse communities.

Empirical results gathered from psychological research studies guide practitioners in developing effective interventions and techniques that clinical psychologists employ - proven, reliable results that improve lives, mend troubled relationships, manage addictions, and help manage and treat a variety of other mental health issues. Clinical psychology integrates science with practice and produces a field that encourages a robust, ongoing process of scientific discovery and clinical application.

Role

Clinical research psychologists integrate the science of psychology and the treatment of complex human problems with the intention of promoting change. The four main goals of psychology are to describe, explain, predict and control the behavior and mental processes of others. This approach allows clinical researchers to accomplish their goals for their psychological studies, which is to describe, explain, predict, and in some cases, influence processes or behaviors of the mind. The ultimate goal of scientific research in psychology is to illustrate behaviors and give details on why they take place.

Clinical psychologists work largely in health and social care settings including hospitals, health centers, community mental health teams, Child and Adolescent Mental Health Services (CAMHS) and social services. They often work as part of a team with other health professionals and practitioners.

Salary and Education

The mean annual salary of a clinical psychologist is about $69,000, however, those with doctoral degrees can earn salaries of $116,343 or more. This industry is highly stable and growing, as psychological research becomes more important to various other industries.

If you want to become a clinical research psychologist, you need a master’s or doctorate degree. In these graduate programs, you will be trained at how to navigate this large body of research. In addition, many clinical psychology students are able to make significant contributions to the field during their education by assisting in labs and learning valuable field knowledge.

Research in clinical psychology is vast, containing hundreds if not thousands of topics. By engaging in research, we are investigating new ways to understand the human mind, and developing solutions to enrich the lives of all others, many students create current and up-to-date with psychology research at universities and research labs across the world.

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

• Clinical Research Coordinator Training

• Pharmacovigilance Certification

• CRA Training

• ICH-GCP Training

• Clinical Trials Assistant Training

• Advanced Clinical Research Project Manager Certification

• Advanced Principal Investigator Physician Certification

• Medical Monitor Certification

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

A clinical research director works to provide leadership in clinical research settings. They help oversee the overall evaluation and development of drugs or healthcare solutions, programs designed to prevent or treat infectious disease, and more. In short, they are responsible for the management of the research side of a healthcare organization.

For those looking to excel in such roles, gaining specialized knowledge through courses like the Advanced Clinical Research Project Manager Certification and Advanced Principal Investigator Physician Certification can be essential.

The director of research is a management position within the development services function. Research directors supervise the research staff. They set departmental and individual employee goals and provide routine evaluations of progress toward these goals.

Job duties

• Develop operating procedures and ensure that the entire clinical research team follows those procedures. For comprehensive training on clinical research standards, consider the ICH-GCP course.

• Create good overall guidelines for clinical research and ensure that the guidelines are followed

• Assist in procuring specimens and samples for research needs

• Help balance budgets and oversee the management of the clinical research team

• Ensure that all federal and state regulations are followed completely

• Handle HR roles including overseeing the hiring process and the employee management process. Enhance your skills in clinical research management through the Clinical Research Coordinator course.

• Present progress reports and strategies for upper-level management

• Serve as a director over the work of those employees who work under you

In essence, the job is a management level position that focuses on directing, organization, and administrating a clinical research facility. It is a role that requires a number of skills and capabilities, but one that offers numerous rewards to those who can excel in the position.

Characteristics

There are abilities that will only be mastered through education, but strengths in the following personal areas will have a big impact on your ability to excel in the job:

Strong Communication Skills – As a director, you’ll end up having to discuss options with your employees as well as your superiors. You will also be meeting with policymakers. Good communication is vital in these scenarios.

Confidence – You’ll also need to have confidence in your own abilities in order to complete your duties without hesitation or worry.

Strong Leadership Skills – In general, you’ll need good leadership skills in order to thrive in the role. Develop these skills through targeted training like the Clinical Trials Assistant Training.

Nature of the Work

The work will take you from the lab to the office to the board room….Further your expertise and adaptability in the field with courses like the CRA course and Pharmacovigilance Certification. As a clinical research director, you’ll divide your time between overseeing the activities going on in a facility, as wells as managing information and reports in your office. In some instances, you may have to visit conferences and other public functions in order to further hone your skills or to make the connections needed to move your research facility into the future.

Average salaries in the field vary around $132,000. While the low end of the salary range is roughly $87,000, it is still well above the national salary average for other jobs. In short, the position is one that can offer incredible pay and plenty of other benefits as well.

Take courses from CCRPS and learn more on how to become a clinical research director. Explore our wide range of certifications, including Medical Monitor Certification to broaden your expertise.

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

This one-year certificate program, will let you learn research design concepts, analysis, and the quality assurance required for daily operations in the clinical research field. You will examine clinical studies across the pharmaceutical, medical device and natural health product sectors that give the competitive edge required in this dynamic industry. In this hands-on program, you will work alongside industry professionals and develop a network of contacts ahead of graduation.

The Clinical Research Certificate provides training in research methods for faculty members, postgraduate residents, international fellows and community-based health care professionals who want to improve their knowledge and skills in research methodology and quality improvement. For those interested in deepening their practical expertise, consider the Clinical Research Coordinator course from CCRPS.

Completion of the certificate will significantly enhance your ability to understand, effectively use, engage in and collaborate in research. It is not intended as a substitute for a research-based graduate degree, nor is it intended to lead to independent research projects (i.e., to take on a Principal Investigator role on large projects). For more intensive roles, the Advanced Principal Investigator Physician Certification might be suitable.

Work Experience

Optional Work Term

Students meeting all academic requirements may have the opportunity to complete an optional work term(s) in a formal work environment. The work term(s) is similar in length to an academic semester and typically involves full-time work hours that may be paid or unpaid. In programs with limited work term opportunities, additional academic requirements and a passing grade on a communication assessment may be required for eligibility. Eligibility for participation does not guarantee that a work position will be secured. Additional fees are required for those participating in the optional work term stream regardless of success in securing a work position.

Your Career

As a graduate of this program, you may pursue future career options, such as:

Clinical research assistant

Clinical research associate (CRA)

Clinical trials monitor

Skills

Throughout this program you will develop the following skills:

Conduct research design concepts.

Analysis and quality assurance of daily operations in clinical trials development process for products such as drugs, medical devices, biopharmaceuticals and natural health products. For detailed training, explore the Pharmacovigilance Certification and ICH-GCP courses.

Identify the roles and responsibilities of the different positions within the clinical research processes.

Learn to incorporate ethical practices.

Program Objectives

After completing this certificate program, students will be better able to:

Construct meaningful research questions applicable to primary care research.

Compare and describe qualitative and quantitative research methodologies.

Design and contrast quantitative and qualitative data collection and analysis procedures

Appraise and critique data reported in the literature from research studies.

Identify, discuss and complete a grant proposal for submission to a research ethics board.

Clinicians seeking greater expertise and confidence in the use of research in their practice should consider the Medical Monitor Certification to further validate their credentials.

Applicants must be health care professionals licensed and in active practice in their country of primary residence and a Certificate of Completion will be issued by the Office of Continuing Professional Development to participants who satisfactorily complete the program.

Learners are evaluated on each component on a pass / fail basis, therefore there is no terminal examination or thesis and all components must be passed.

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

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

Have you ever wanted to live in another country? International clinical research organizations (CROs) are always on the lookout for prospective clinical research professionals to fill the extensive range of positions that abound across the world in different company locations, sizes, and capacities.

The international scene posts new clinical research vacancies and job opportunities daily, and these clinical research vacancies and job opportunities ranges from management roles such as Study Manager (SM), Clinical Project Managers (CPMs), Clinical Trials Managers (CTMs), Clinical Research Coordinators (CRCs), Clinical Trial Assistants (CTAs), Clinical Research Associates (CRAs), and Clinical Directors (CDs) and Physical Investigators (PI) at global, regional, or local levels.

Let's take a look at some of the most popular international clinical research professional jobs on offer right now (as of May, 2019).

• Clinical Project Manager: RBW Consulting Services located in the United Kingdom. Salary £55,000 - £65,000.

• Clinical Project Manager: Cobham company in the United Kingdom. Salary £60,000 - £79,999.

• Clinical Project Manager: Piper Company in the United States. Salary $125,000 - $140,000.

• Clinical Trial Manager: PRA Health Services in the United States. Salary $117,000 - $171,000.

• Clinical Director: United States Department of Health and Human Services. Salary $137,849 - $262,000.

The opportunities are diverse. You find find work ranging from medical technology, to pharmaceutical companies, to contract research organizations. A competent clinical research professional can find opportunities to work on various clinical trial projects in multiple companies.

No one will pay for half-baked professionals. Therefore, you have to develop yourself by taking courses from CCRPS and learn more on how to become a successful clinical research professional with these specialized courses:

• Clinical Research Coordinator

• Pharmacovigilance Certification

• ICH-GCP Certification

• Advanced Clinical Research Project Manager Certification

• Medical Monitor Certification

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

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