Certified Clinical research Professional (CCRP)
WHY BECOME A CLINICAL RESEARCH ASSOCIATE or coordinator or regulatory CLINICAL RESEARCH specialist?
CLINICAL RESEARCH CERTIFICATION
Over 1.9 million students receive a bachelor of science every year. While a few go on to Ph.D., Masters, and Medical programs; many are ready to start clinical research certification to start a career in the frontiers of medical research and patient care. As a new student applying to the science job market, you may only find internships or recognize that even entry-level science jobs require 1-2 years of experience. More so, you may realize many of these jobs require intense labor in the labor just did not meet your expectations for your science degree. This is why a career as a CRA should be considered with clinical research coordinator training. We train many students each month in clinical research coordinator training, clinical research associate and clinical research regulatory training (depending on prior background).
A Clinical Research Associate or Coordinator directs and supervises clinical trials that are run by physicians, nurses, and other science-degree holders. Unlike the jobs you currently can apply to on the market, a position as a CRA is actually much more difficult to obtain. While many generic courses exist on the market; we have seen that many of these students cannot find a job afterward because of the lack of content depth. This is why our course offers a Senior Clinical Research Associate level of training with 111 intense modules. This science-based medical position is now a high-demand job which can be done privately for pharmaceutical companies such as Pfizer, or academically in medical schools. We have the largest number of clinical research programs.
Nonetheless, for those who have always wanted a career in medicine or have a gap year before medical school; Clinical Research Training is the next step to getting a head start in your career. Because the position is unlike actually working in the lab and requires a management role; you get 1-on-1 connections with physicians and medical staff that can lead to a better application for medical school and other medical careers later on.
Best of all; many of these positions accept remote staff (and some allow you to travel 45-75% with full expenses including travel, accommodation, meals, and other per-dime expenses covered). Clinical Research Training can help you save money while also increasing your salary. CRA’s with our level of training can expect to make between $6,500-$12,000 a month with an estimated promotion rate of 33% a year; an amount that is not common in other science-degree careers.
Many CRA students are actually matriculated, foreign doctors. In fact, some of our Clinical Research Training Students come to us immediately after moving to the U.S. and questioning what to do with an MBBS degree in the US.
Unlike what you’ve learned during your 3-8 years in university or graduate school; the information needed for Clinical Research Training after your degree. Is rarely a repetition of any course you’ve taken before and thus we have 111 Clinical Research Training modules (more than any other course available) to make you get the position you want as a CRA.
Clinical Research Analyst Program
A Clinical Research Associate is also a professional widely known as a Monitor, this individual is trained to conduct clinical trials and manage the process. Clinical trials are usually implemented by physicians at hospitals, clinics, or physicians’ offices. The CRA is a professional trained to oversee the initiation, progress, and conduct of the clinical trials and ensure the scientific integrity of the data collected, and the protection of the safety, rights, the well-being of the study subjects and these subjects are human beings.
- CRA’s duties include among others the following:
- Monitoring that the physician sticks tenaciously to Good Clinical Practices and the study protocol.
- Performing and ensuring study drug accountability;
- Verifying and validating the documentation of the informed consent process for each study subject;
- Ensuring strictly that non-serious and serious adverse experiences are properly documented and reported.
- Reviewing and ensuring the completeness and accuracy of the case report form against the subject's medical record;
- Ensuring strictly the filing and maintenance of the required regulatory documents.
The CRA usually has a science and or health care background (e.g. Bachelor's, Master’s, or a Ph.D. in science, nurse, medical technologist, or physical therapist). The CRA is most frequently employed by a pharmaceutical company, contract research organization, academic institution, or site management organization. A CRA usually works either in-house or in the field, requiring 50-70% travel. As a field monitor, CRA will visit multiple sites and interacts with the study coordinator and the investigator conducting the trial.
Pharmaceutical companies are presently fast-tracking or crashing the development time necessary for their products to receive FDA approval so that the products can go into the market fast. Monitoring of a clinical trial is the first step in identifying potential data differences, discrepancies, and regulatory issues. Insufficient and or inadequate monitoring can jeopardize the safety of the study participant and/or is a leading factor to the delay in gaining drug approval. Well-trained and knowledgeable CRAs play vital roles in protecting the study participants and help to reduce the pace of time between drug development and marketing approval. The demand for well-trained CRAs will continue to grow because their supply is highly limited.
- Clinical Research Professionals in the Drug, Device and Biologic Industry.
- Clinical Research Analyst Certification
- 150 Hour CRA Certificate Program Course Structure.
Clinical Research Coordinator (CRC)
CRC courses provide foundational and advanced role-based training for clinical research professionals. The courses cover information that expands beyond but is directly connected to the Human Subjects Research (HSR) and Good Clinical Practice (GCP) courses.
The Foundations course delivers basic CRC training that organizations may use for onboarding new CRCs. Included are the operational and regulatory essentials that CRCs need. It also provides a basis for learners who will later move on to the advanced course.
In the Advanced course, learners gain a deeper understanding of the CRC’s role by exploring key operational, leadership, regulatory, and technical elements associated with daily work.
These courses were written and peer-reviewed by experts.
Language Availability: English
Suggested Audiences: Clinical Research Coordinators, Clinical Research Professionals, Investigators
Regulatory affairs clinical research specialist program (RACRS)
The regulatory affairs industry oversees the development of foods, drugs, and medical products. Products are certified in meeting standards satisfactory for human use throughout the process of development, testing, manufacturing, marketing and distribution by specially-trained professionals.
Regulatory affairs specialists play a vital role in the well-being of the global population by monitoring the development and distribution of safe, healthy foods and technological advancements in medicine. Though regulatory affairs specialists work in a wide variety of disciplines such as public policy, health, science, economics, and law, they share the common goal of facilitating the saleability of products that are safe and effective for consumption and use by the public.
The majority of regulatory affairs specialists work in industries such as the pharmaceutical, biotechnology, food science, and medical device sectors. Others work as consultants in marketing, research, or law entities. Some are employed by hospitals, healthcare, and clinical research organizations, as well as in academic settings and government agencies.
The scope of activities of a regulatory affairs specialist varies depending upon the context in which one works. The specific tasks of individuals employed in this profession may include:
- Coordinating compliance documentation
- Examining product information
- Updating legal or regulatory knowledge
- Evaluating laws and regulations
- Explaining regulations, policies or procedures
- Overseeing business processes
- Obtaining authorization for activities
- Communicating with government agencies
- Maintaining data systems and databases
- Establishing organizational policies and guidelines
- Examining financial records and processes
- Preparing financial documents
- Training personnel
- Corresponding with customers
- Monitoring business indicators
- Analyzing environmental regulations
Not only is the market for regulatory specialists growing, but it is also changing as new technology becomes available, such as the move towards electronic formats for regulatory submissions
The requirements for applicants that plan to undertake the Clinical Research Associate Training Program are any of the followings:
Bachelor, Master’s in a Science or Allied Health Field OR
Healthcare Professionals (e.g. RN, PA, MD, PT, RPh, PharmD, or Medical Technologist
The candidate will be given a certificate of completion of the Clinical Research Professional program, in addition to another certificate of recognition for passing the GCP Regulatory/ICH Guideline exam