CLINICAL ResearcH CERTIFICATION
Accredited I Self-Paced I Instant Access & Certification Upon Completion
CCRPS is known for our clinical research online training for Clinical Research Associates (CRAs), Principal Investigators (PIs), Clinical Research Monitors, Regulatory Affairs, ICH GCP Protocol, Clinical Quality Management and other crucial clinical research purposes, CCRPS Clinical Training’s strategy provides students with self-paced online training experience based on core competency accredited by the ACCRE.
As educators in clinical research training, CCRPS Clinical research training programs vary based on student’s location, time, and learning demands. These self-paced online modules, interactive tutoring sessions, or online monitored competency examination, CCRPS clinical training provides a clinical research fast track approach to getting hired in clinical research.
CCRPS Clinical training is able to provide large-group online training options for clinical research professionals and CROs globally. It is widely known for its comprehensive education and training programs. CCRPS clinical training helps clients improve their programs by enhancing staff knowledge via its extensive online course and examinations.
Certified Clinical Research Professionals Society Corp NPO and it’s certification courses are accredited by the Accreditation Council for Clinical Research Education - ACCRE. 116E 15th Street, Los Angeles, CA 90015,
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Clinical Research Course Reviews
Below are our ACCRE accredited clinical research certification programs:
ACCELERATED clinical research associate certification & Internship
140 module training online and competency exam over 16 days with 14 days on remote or local internship - Used to enhance knowledge and experience to work as a clinical research associate and apply for higher level positions in the clinical research monitor to senior CRA realm. No clinical research background required but is preferred. Students must provide information regarding internship dates and location (online, remote, local) prior to starting modules. Internship is guaranteed along with assistance in job placement.
Payment plans from 3-6 months are available upon qualification and request. Please email our enrollment team at firstname.lastname@example.org to get information regarding payment plans or partial scholarships.
clinical research associate certification
100 module training online with competency exam with 60 day period of completion - Use to enhance knowledge for promotion to CRA, SrCRA, or other management levels in clinical trials. Can be taken by physicians, nurses, and bachelors, masters, and PhD graduates. No clinical research background required for enrollment and certification.
ICH GCP Certification
16 module training online - No clinical research background required. ICH GCP certification is required by all jobs working with clinical trials.
CLINICAL TRIALS ASSISTANT CERITIFCATION
27 module training online - Minimum of high school degree or GRE is required. Use for jobs that require clinical trials experience and knowledge. No clinical research background required
clinical research Monitor certification
80 module training online - No clinical research background required. Bachelors degree required.
clinical research nurse certification
110 module training online - No clinical research background required. RN or BSN required.
For clinical research associate entry level training
Learn about the PayScale and promotion methods for Clinical Research Associates by scrolling below.
CCRPS Course DATA
CCRPS Course covers double to triple the amount of course content than other courses. While many courses are simply 5-20 simple interactive modules, our course covers 140 dense modules in thorough detail. After each session, students can ask their questions privately with the course instructor, all of whom have 15+ years of CRA experience. We offer clinical research courses distance learning.
There is a huge shortage of well-trained CRAs, but many companies are reluctant to hire untrained entry-level clinical monitors because of patient and trial safety. Because of this, even the beginner entry-level jobs require certification or training. Most courses provide very light training that may look good because of the company names, but alone is not sufficient to pass the interview rounds a company conducts. Because we prepared our modules to stand by you even as a Senior Clinical Research Associate, we find more of our students with no background quickly passing their interview rounds. Our program is considered one of the top clinical research graduate programs online.
Currently, 82% of our students are hired within the first month of taking the course. Students with limited background or those looking to gain extra experience are offered a remote internship of up to 6 months during the time they are interviewing. This advantage allows many students with limited experience to get hired with a higher paying job than previously offered. For exam, nurses are offered our clinical research nurse training and can additionally take our clinical research management training.
While a majority of our students are physicians, a majority of the CRA workforce are Science Grads and Nurses. We train at a Senior CRA level for all students regardless of background because clinical research monitoring is vastly different from any lab or science course you may have taken. Clinical research associates are given the protocol of a study including all medical protocol that must be followed but because they do not diagnose or treat, the medical knowledge is supplemental but not sufficient in this career path. This is the main reason why our Clinical Research Training includes all possible scenarios you may face at the protocol and guideline level in your future company.
CLINICAL RESEARCH ASSOCIATE TRAINING AND PLACEMENT
Learn about our partnerships with dedicated clinical research recruiters by inquiring. We provide an 8 module job application preparation section in our CRA certification course.
Always use a cover letter specific for the company and job when applying if you are not using a recruiter.
Why Become A Clinical Research Associate?
Find out the pros of this career field below.
We are the only major US-based ACCRE accredited certification course that accepts students with no prior background for CRA certification. This is because our course is thorough and created by Senior CRAs who have been in the field for long enough to understand what you need to know to begin working and applying. The course can be completed in as little as 7 days with dedicated full-day study time.
clinical research Training online
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 who opted not to take the USMLE or repeat their residency training. 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 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 110 Clinical Research Training modules (more than any other course available) to make you get the position you want as a CRA.
clinical research certification
Over 1.9 million students receive a bachelors of science every year. While a few go on to PhD, Masters, and Medical programs; many are ready to start clinical research certification online 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 requires 1-2 years of experience. More so, you may realize many of these jobs require intense labor in the lab or 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 over 100 students each month in clinical research coordinator training and clinical research associate 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 afterwords because of the lack of content depth. This is why our course offers a Senior Clinical Research Associate level of training with 110 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 courses online.
ADVANCED Clinical Research Associate Training and Placement
The role of the clinical research associate is very important in clinical trials to ensure that medical devices, new treatments and new drugs are approved for patients' use.
This field is taken as a certificate program course in many schools. You may also discover the availability of associate degree programs depending on the school. These programs can be completed in two years and can be offered through both the online and the hybrid formats. Hybrid formats combine both online and on-campus courses together.
If you opt for an online program, different platforms like emails and discussion boards are used to ensure and promote interaction between the students as well as with the lecturers. Online learning platforms are used to upload the syllabus, course materials, lectures and assignments. Some online programs include field work as part of their requirements, in order to gain first hand experience working with clinical trials and patients. Depending on the school, they may have a list of approved clinical research institutes and other facilities. Otherwise, you will have to find a facility for yourself and get the school's approval.
These certificate programs are generally designed for professionals that are already in the medical fields like medical assistants, nurses etc, and are interested in moving to the field of clinical research. They may therefore ask for a copy of your CV or resumé or they may ask for a letter from your employers to verify that you have the needed medical experience. Some programs may require just an undergraduate degree in a medical science or life science related field.
Clinical research associates are trained to assist clinical researchers and investigators in the coordination, administration and management of clinical trials. During this training, different courses will be taught revolving around subjects like safety procedures, subject recruitment, regulatory requirements, drug development, accountability, trial management, medical terminology etc.
The importance of the role of the clinical research associate means that companies that conduct clinical trials are usually very selective, the need to comply with strict regulations often inform their decision when making a choice of their clinical research associate. It is therefore very difficult to get a job as a clinical research associate without previous experience of clinical trials. Many companies require around at least two years experience in clinical monitoring as a clinical project assistant or clinical trial administrator before considering applicants for this important role.
In applying for the post of a clinical research associate, ensure that you read the job description and indicate or highlights the relevant experience on your curriculum vitae. Your cover letter should be specific to the company you're applying to. Do not use a one-for-all cover letter. Personalize your cover letter to each company and highlight the skills that fit the specific requirements of the role. Not all companies advertise their vacancies, so you can try to find out about other unadvertised vacancies, you might get more chance with that.
Further certification can enhance your resume such as the ACCRE accredited CRA program which contains 110 learning modules for Clinical Research Associate Training and Placement
Clinical Research MONITOR Training
clinical research MONITOR training
While several careers exist with a science degree, the best exposure to a medical career with a science bachelors is through Clinical Research Training. This can be taken as early as your senior year of college to prepare for a job directly out of university.
CRA positions right out of undergrad are nearly impossible to get due to the yearly 1.9 million graduates of science degrees (and approximate 2,000 applications per position). This is why Clinical Research Training is an essential investment in your career.
CRA positions after hiring will cover the expenses of travel, housing, food, and more if visiting clinical sites. Most pay $6.5-12k a month with the potential to move on to a CRA position after 2 years.
While many positions will fund or reimburse your CRA training; securing an initial position is the tough part. This is why our Clinical Research Training provides 110 clinical research training modules and interview preparation with a Senior CRA and Physician of 25 years.
Our Clinical Research Training makes almost anyone interested in making use of their science degree in medicine possible. We take on students with no medical background to full-on doctors looking for a better position due to their international medical degree.
We also offer private Principal Investigator Training for practicing physicians.
Clinical Research Training for Nurses
Nurses are known to be the ones who provide direct care for the patient. Some nurses are also familiar with the role of nurse scientist. However, nurses may take up roles that are completely new to them within the world of clinical research. These roles include clinical research coordinator, educator or manager. They can also take up less traditional role like regulatory specialist, study monitor and IRB (institutional board review) admin.
Regulatory specialist: their activities relate mainly with preparing regulatory documents and communicating with regulatory bodies. Nurses can work as regulatory affairs specialist, regulatory operation coordinator, regulatory coordinator. They can work with government agencies, pharmaceutical companies, academic medical centers.
Study monitor: they monitor clinical research practices and make sure that it complies with necessary research protocols and regulations. They can also work at government agencies, biotechnology companies, pharmaceutical companies, contract research organizations, device manufacturers etc.
Institutional Review Board (IRB) administrator: they are the professionals in charge of overseeing, administrating, implementing and managing IRB activities. The activities could be policies and procedures that relates to protecting the welfare of humans. They can work at all IRBs, local, commercial or central IRB.
Nurses that have developed interest in the field of clinical research can associate with professional organizations, this provides them with the opportunity for networking and option to continue their education through mediums like conferences, webinars, discussion groups, publications and online resources. These avenues serve as part of their clinical research training.
Certification is often a parameter used to measure professional expertise. This is based on a particular criteria that reflects skill, knowledge, educational preparation, ability and competence that are developed from experience in that area of specialization. Nurses that developed interest in clinical research and have undergone a clinical research training program can have an opportunity to be certified through the:
This field of clinical research gives nurses a chance, an opportunity to advance themselves professionally in a field that might not have been explored by them before.
Nurses that have gone through the clinical research training, otherwise called research nurse can carry out research on the various aspects of the human health, such as illness, pharmaceutical and health care methods and treatment plans. The main aim of this research is to improve the quality of health care service delivery.
Roles of Research Nurses
They are responsible for designing and implementing research studies.
They observe procedures for treatment, collect and analyze data.
They report their research results to appropriate quarters.
They write articles and report their research findings in nursing or medical professional publications and journals.
They help in recruiting participants for studies and are involved in providing direct care for the participants.
Nurses can make use of their communication skills as well as their critical thinking skills gotten from their knowledge and experience in healthcare to further their career in this exciting way.
Our course allows new and current nurses to become certified to work as CRCs/CRMs/CRAs and nurse researchers with no prior experience.
ICH GCP CERTIFICATION
ICH is the abbreviation for International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. The ICH is an international body that sets the standard which becomes regulations for clinical trials involving human subjects. The ICH sets the standard that defines the guidelines for Good Clinical Practice (GCP).
GCP is an international standard that ensures that ethical and scientific qualities are maintained in the designing, recording and reporting of clinical trials involving human subjects.
The aim of this regulatory standard is to ensure that the well-being, right and safety of the human beings recruited for clinical trials are protected. It also aims to ensure that data gotten from clinical trials are accurate, reliable and credible, irrespective of wherever or whatever clinical research facility that the trials are being conducted in the world.
ICH GCP certification is a formal recognition of an individual's knowledge and competence in their ability to carry out applicable GCP guidelines under different circumstances.
It is important for all professionals in the clinical research industry to get the much needed training in Good Clinical Practice (GCP) and be certified as well. As a matter of fact, most companies now take measures to ensure that their staff are GCP certified. Being GCP certified has become a minimum requirement for anyone who would like to explore a career in the area of clinical research.
Although all clinical research professionals are required to be GCP certified, GCP certification is of more importance to the following individuals:
Investigators from drug companies, research centers, hospitals etc.
Ethics committee members.
Students that are interested in working in the clinical research industry.
It is highly recommended all over the world to get the Good Clinical practice (GCP) training and certification if you are a clinical research professional or you are aspiring to be one. That is the least acceptable standard to work in the clinical research industry. Beyond GCP certification being a required minimum for a clinical research professional. There are a few other reasons why you need the GCP certification. They include:
It is a global formal acknowledgement of an individual's professional eligibility to work as a clinical research professional.
In order for organizations involved in the business of clinical research to comply with the laid down industry guidelines and regulations, Good Clinical Practice (GCP) training is important for members.
GCP training equips the participants with the knowledge of the regulations that are applicable in clinical research.
Pharmaceutical and biotech companies, as well as contract research organizations recommend that their employees are GCP certified.
ICH GCP in today's clinical research world is now more important than ever. The evolution of medical science and the complexities of research process highlight the importance of guidelines that ensure that clinical research are carried out properly.
CCRP’s online ICH GCP certification course can be completed in 2-3 days online to receive ICH GCP certification for your current job or future job. It is required in many fields in order to conduct clinical trials and we offer an in-depth overview of ICH GCP through our module course.
Our ICH GCP certificate is compliant with 2019 ICH GCP protocol and accredited by the Accreditation Council For Clinical Research & Education; the only major accrediting body for clinical research education.
Clinical Trial Assistant Training
The work of a clinical trial assistant in the set up of a clinical research can never be overstated. It is an important job that requires a whole lot of interest in order to be successful as one. If you have developed interest in becoming a clinical trial assistant, there are certain questions that you must ask yourself. Are you really cut out for this career path? Can you ensure that your availability during the duration of a research from start till its completion, to monitor the trial subject and ensure that the trial is conducted in a safe and ethical manner? Are you eager to take up more responsibilities in a work place? If your answers to this questions are yes, then you might just be cut out for the job of a clinical trial assistant.
A clinical trial assistant or clinical research associate have a lot of responsibilities and roles to fulfil within a clinical research institute to ensure the success of a clinical research. Some of these responsibilities include:
They are responsible for maintaining the standard operating procedures (SOP).
It is their duty to provide regular report updates of the progress of clinical studies to the appropriate personnel.
They are involved in the planning and conducting of pre-study site evaluation.
They conduct clinical site feasibility and are as well involved in study visibility.
They assess the study subjects to ensure that the appropriate clinical protocols are observed and the trial is in sync with laid down regulations.
The minimum educational requirement for an entry level job as a clinical research associate is an undergraduate degree in health sciences related courses like nursing, life sciences, medical science, biotechnology etc. A diploma in clinical research from a reputable clinical research institution is also another way to go. But graduate degrees offer more benefits and opportunities like a higher pay, eligibility for senior positions etc.
Another avenue through which you can become a clinical trial assistant is through the administrative side. This is possible and is most common for people without formal education in the fields mentioned. It is however a tasking work and very demanding as it requires a lot of administrative knowledge in the area of clinical research.
To be successful as a clinical research associate, there are certain skill sets that are required.
A knowledge of the challenges and restrictions involved in the implementation and retention of databases.
A complete understanding of the responsibilities and liabilities involved in the use of humans for trial tests.
An ability to make excellent clinical development plan.
Must be able to ensure that data gotten from clinical trials are accurate and reliable and the legal rights and privacy of the subjects are protected.
Having these above listed skills and being efficient in them make the job of a clinical trial assistant easier and more interesting.
Clinical research associates can work in several kind of organizations including:
Clinical research organizations (CRO)
Biotechnology companies etc.
Becoming a clinical trial assistant does not require much. If you're interested, get a degree in the required field and then apply afterwards to increase your chance of success.
CCRPS' offers complete clinical trial assistant training and certification by the ACCRE through our clinical trial assistant training course. Enroll below:
Clinical Research Training
Designed For Nurses, Physicians, and Science Graduates To Earn The Knowledge of A Senior Clinical Research Associate In 30 Days with Clinical Research Training Online.
CCRPS Course has successfully trained over 1,000 students through our instructors. Our lead instructor, Dr.Kamal T Dhaliwal has worked in the industry for over 25 years. In this time, she alone has lead education efforts for Clinical Research Training for many companies. With a background in education, the modules produced by our Senior Clinical Research team educate students up to the Senior Clinical Research Associate level regardless of current background. This has allowed clinical research training students to surpass the need for further training once hired, allowing for quicker promotions and hiring.
Unlike institutes which offer several types of training costing upwards of $7,000 to get up to the Senior Clinical Research Associate education, our single Clinical Research Training course trains all students up to this level. Most importantly, it provides access to students with less than the required 2 years of clinical research monitoring experience to become certified in the industry and secure their first job. In Clinical Research Training, students choose our course due to gaining 1-on-1 access to 110 clinical research training modules, and intensive training that can be completed in 30 days (and sometimes less). This allows students to choose the pace they want to enter the new industry and also complete the course online while working, studying for licensing exams, or waiting for residency/medical school entry.
Travel or Work Remote
While 90% of our students are physicians (MDs, MBBS, IMGs), many students find a position paying more than they expected. Their favorite part of the position is being able to choose to travel (expenses covered) or work remote.
Clinical Research Training for Science Graduates
Science graduates with a bachelors, masters, or PhD in science fields often look into Clinical Research Training in order to advance their career. Working as a clinical research associate is one step up the ladder compared to an assistant or conducting the trials yourself. Rather than conducting the trials, you are put in charge of several trials in many medical hospitals, schools, and pharmaceutical labs around your region. The companies place priority on their staff for promotion which is why there is a 33% chance of promotion in the first year. Premed students in their gap year prior to medical school choose the Clinical Research Training route to get relations with admissions and faculty of medical schools while earning over $60,000 a year. Students with a masters of PhD are seeking the option to earn over $100,000 a year in a field that fosters a similar amount of discovery and exploration as their programs. Clinical research jobs offer this opportunity as well as the ability to transfer into management positions in the pharmaceutical and medical industry.
Clinical Research Training for Nursing Graduates
RNs and BSNs looking to enter the management field without excess on-floor or heavy-duty hours look into clinical research training as the next step. While 90% of our students are physicians, more than half of the clinical research associate workforce are former nurses. The position allows nurses to early more while working in a job with less demanding hours. Clinical research associates are commonly nurses because of their prior medical experience and many companies look to hire while keeping this background in mind. Many companies look for nurses also because of their attention to detail which is needed in the high-stakes field of clinical research where observation of trials and data is key. Because we provide up to the Senior level of clinical research training, nurses do not need further certification to be promoted if they are already in the field.
Clinical Research Training for Physicians (MDs, MBBS, IMG, FMGs)
90% of our students are physicians who are trained US medical graduates with or without residency, MBBS graduates, International Medical Graduates, and Foreign Medical Graduates. Many physicians choose to switch to clinical research because physicians are quickly hired and promoted along the pharmaceutical or medical institution they work for. Physicians who are taking the USMLE work as CRAs during their waiting year(s) in order to work in a job that pays enough to save, support their family, or give them enough time to be with their family by working remote. Physicians who were unable to find residency also choose this path because clinicians are treated as doctors in this field when monitoring and can still hold their MD title while working. Further, no physician is considered over-qualified for this position as most will be promoted to Senior CRAs within the first year. This can also be the best option to earn over $100,000 with a career more flexible and less demanding than many physician careers. Many physicians choose to enter the management sector as COOs, CEOs, and company executives after their first few years.
Principal Investigator Training
CCRPS offers online principal investigator training to physicians and doctorate-level degree holders interested in beginning a career as a PI. The principal investigator training course is a 1-on-1 course designed to assist in obtaining the knowledge needed for initial PI roles. Because US PI certification requires at least 6 months of experience as a principal investigator, physicians in our online principal investigator training program seek this course to assist in their preliminary positions as a PI prior to the national PI certification exam.
Our 60 hour principal investigator training course is designed to be one of the highest-density courses in the industry for principal investigators. Obtaining 60 hours of training on a 1-to-1 basis allows for doctorate-level degree holders to gain fundamental skills to secure a position as a principal investigator. This also ensures the basis of the online course to be beyond that of broad concepts, and tailors to each student’s needs in applying the concepts.
CCRPS offers online, self-paced modules for principal investigators because we understand the demand of current jobs, research internships, board-certification exams, and family that can impact learning. While these modules are self-paced, all principal investigators are monitored daily by our Senior PI instructor to ensure adequate speed and retention.
I Have A Degree In Science/Medicine. Now What?
We cover all the common questions our bachelors graduates ask when desiring a medical career with a bachelors degree.
DO I NEED A MASTERS TO GET A JOB WITH MY SCIENCE DEGREE?
A masters is an option many science degree holders take but it not always the best bet. Now, many masters science degree holders apply for jobs but are still placed in a lab and in a work environment they do not see growth in. A masters will only further your position in the lab, and less so in a career with potential. The best option is to consider a thorough Clinical Research Training course that can establish the experience and clinical research training needed to be hired, succeed, and advance in a medical-focused science career.
ARE THERE COURSES AFTER MBBS IN USA?
Many MBBS or foreign medical graduates opt to not take the USMLE or finish residency again but still desire a medical job with a similar amount of professionalism and recognition. A CRA position is the best next step after an MBBS in the US to work as a medical professional alongside many doctors who you will actually supervise and have equal-level relationships with. We offer advanced training for CRA certification for this very purpose. In fact, 20% of our Clinical Research Training graduates are MBBS holders, many others are IMGs.
WHAT SCIENCE DEGREE JOBS ARE IN DEMAND?
When you look for science degree jobs; most of them are in the lab actually conducting trials whereas a CRA supervises and reports them. If you want to apply your science degree without the manual labor of pipets and syringes, a CRA position can establish your footing in medical-leadership roles with your Clinical Research Training.
ARE THERE REMOTE JOBS FOR SCIENCE DEGREE HOLDERS?
The best known remote jobs for science degrees are CRAs after getting Clinical Research Training. You can work from home making $6.5-12k a month while having your internet, cell phone, printing, and laptop expenses reimbursed.
ARE THERE TRAVELLING JOBS FOR SCIENCE DEGREE HOLDERS?
Feel like you haven’t seen enough of the world because of studying so much in undergrad? CRA’s have the option to travel 100% with food, housing, and travel covered. You can choose which sites you want to travel to and arrive early to explore the cities and countries even more after Clinical Research Training.
Clinical Research Certification
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ICH GCP TRAINING
The ICH GCP training modules go over the entire ICH GCP guidelines in detail. They teach you how to apply them rather than just understand the protocols. This is the essential basis of Clinical Research Training.
1. An Introduction to Clinical Research
2. An Overview of ICH GCP
3. Code of Federal Regulations
4. FDA 21 CFR Part 11 ( Part 1 and 2)
5. ICH GCP E6 Section 5 - Sponsors Responsibilities
6. ICH GCP E6 Section 4 - Investigators Responsibilities
7. ICH GCP E6 Section 4 - Investigators Responsibilities – Informed Consent Form
8. Reporting Responsibilities of the Investigators
9. Ethics of Research Involving Children
10. Ethics of Research Involving Mentally Incapacitated
11. Ethics of Research Involving Pregnant Women and Fetuses
12. Ethics of Research Involving Prisoners
13. ICG GCP 5.5 Trial Management – Data Handling and Record Retention
14. ICH GCP E6 and E2A - Adverse Events
15. Safety of Human Subjects in Clinical Research
Reference Modules - to be used for reference purposes only:
a) Common Terminology Used In Clinical Research
b) Commonly Used Abbreviations and Terms in Clinical Research
The quality monitoring modules are needed to work as a supervisor on clinical trials. This is the section not available in any other entry or introductory clinical research training course with more detail than many new Senior CRAs know. These modules allow you to obtain the application, examples, and guidelines needed to monitor trials with ease in your new position.
1. Duties and Responsibilities of a Clinical Research Associate
2. Designs of Clinical Trials
3. Phases of Clinical Trials
4. Pre-Clinical Trials
5. Stakeholders in Clinical Research and Their Relationships
6. Contract Research Organization- CRO
7. Randomized Controlled Trials
8. Types of Monitoring Visits
9. Site and Investigator Selection
10. Site Qualification Visit
11. Routine Monitoring Visit
12. Monitoring Tools and Notes
13. Checklists for Pharmacy Monitoring and Inspection Visits
14. Site Close Out Visit
15. Source Documents
16. Inclusion Exclusion Criteria in Clinical Research
17. Interactive Voice Response System - IVRS
18. Protocol in Clinical Research
19. Protocol Deviations and Violations
20. Institutional Review Board
21. Quality Control in Clinical Research
22. Data Safety Monitoring board- DSMB
23. An Overview of Remote Monitoring
24. Centralised Versus Onsite Monitoring
25. Electronic Data Capture and Remote Data Capture Basics
26. Remote Monitoring of Clinical Trials and EMRs
27. Blinding in Clinical Trials
28. Communication between Blinded and Unblinded Staff
29. Investigational Product Storage and Dispensing
30. Investigational Product Accountability in Clinical Trials
31. Adverse Drug Reactions
32. Basics of Adverse Event Monitoring
33. Adverse Event Reporting
34. Risk Based Monitoring
35. Pharmacovigilance (Part 1)
36. Pharmacovigilance (Part 2)
37. Safety Reporting Requirements for Sponsor Investigators
38. Investigator Initiated Multi Center Trails
39. IND and NDA Process
40. Guidelines for Designing and Completing Case Report Forms
41. Do’s and Don’ts of a Case Report Form Design
42. Introduction to Bioresearch Monitoring (BIMO)
43. Clinical Trial Management System-CTMS
44. Minimising Source Data Queries in Clinical Trials
45. Role of Local and Central Labs in Clinical Trials
Regulatory training allows you to understand and apply the FDA regulation guidelines to each individual trial you will supervise after your Clinical Research Training.
1. Regulatory Documents in Clinical Research
2. Regulatory Affairs
3. Essential Regulatory Documents Guidance and Binder Tabs -Part 1
4. Essential Regulatory Documents Guidance and Binder Tabs - Part 2
5. Electronic Regulatory Submission and Review
6. Financial Disclosure- Duties and Strategies for Clinical Studies
7. Financial Disclosures and Conflicts of Interest in Clinical Research
8. FDA Form 1572 - Part 1
9. FDA Form 1571 - Part 2
10. Delegation of Authority Log – DOAL
11. Investigators Brochures
12. Protocol Continuing
13. IND Application
14. Trial Master File Reference Guide
15. Trial Master File and DIA Model
AUDIT AND INSPECTIONS
The auditing and inspections modules train you to prepare clinical trials for auditing by your company, government organisation, or academic organisation after your Clinical Research Training.
SUBJECT RECRUITMENT, RETENTION AND COMPLIANCE
1. Compliance Requirements in Clinical Trials
2. Subject Recruitment and Retention (Part 1 and Part 2)
3. Increasing Subject Compliance in Clinical Trials
4. Ethical Consideration Associated with Investigator Payment and Patient Recruitment
5. Advertisement aid in Subject Recruitment and Retention6 MODULES
1. Audits and Inspections in Clinical Trials
2. FDA Warning Letter
3. Site FDA Audit Inspection Checklist
4. How to Survive Through an FDA Inspection
5. Do and Don’ts during an FDA Inspection
6. Mock FDA Audits
MISCONDUCT AND FRAUD
1. Scientific Misconduct in Research and How to Prevent It
2. Misconduct in Research – Detecting Falsification
WRITING QUALITY MONITORING REPORTS & FOLLOW UP LETTERS
These modules immerse you in understanding, applying, and learning to write monitoring reports, follow up letters, and professional write-ups required in the CRA position after each clinical site visit or review after your Clinical Research Training.
1. Site Monitor Transition Letter
2. Checklist of Activities for Pre-Study Visit Qualification
3. Pre-study Visit Assessment and Monitoring Questionnaire
5. Pre-Study Visit Follow Up Letter
6. Site Initiation Visit Agenda
7. Site Initiation Visit Confirmation Letter
8. Site Initiation Visit Report
9. Site Initiation Visit Follow Up Letter
10. Site Monitoring Visit Confirmation Letter/Fax
11. Site Monitoring Visit Report
12. Site Monitoring Visit Follow Up Letter
13. Site Close Out Visit Confirmation Letter
14. Site Close Out Visit Agenda
15. Site Close Out Visit Report
16. Site Close Out Visit Follow Up Letter
COMPETENCY TESTING FOR A CRA
The competency testing of your Clinical Research Training modules is the next step needed to ensure that you are ready for your interviews. We establish our CRA’s as future leaders in the clinical trial industry by ensuring you have the full education needed to be promoted in your career quicker than without the course.