CRA Training Course:
Main Function of the Clinical Research Associate (CRA):
The main function of a CRA is to monitor clinical trials. He or she may work directly with the sponsor company of a clinical trial, as an independent freelancer or for a Contract Research Organization (CRO).
A Clinical Research Associate (CRA) ensures compliance with the clinical trial protocol, checks clinical site activities, makes on-site visits, reviews Case Report Forms (CRFs) and communicates with clinical research investigators.
The Clinical Research Associate (CRA) is a profession defined by
Good Clinical Practice guidelines (ICH-GCP). While ICH-GCP uses the term
"Monitor" instead of CRA, the two terms are considered to be
synonymous. The CRA works on behalf of the sponsor. This means that they are contracted by the “sponsor” to perform an independent monitoring function. The “sponsor” can be a pharmaceutical or device company, a granting agency, a university department, a physician, etc. They work independently of the investigative staff conducting the research at the site or institution. This means they do not report to the PI or site manager and that they do not have the ability to change or manipulate data.
The CRA Training Course provides you with the training and Job Placement Assistance necessary to qualify for CRA jobs in the monitoring of clinical trials globally.
Essential duties of the CRA include:
- Verify that the research site investigator(s) and study personnel are conducting the study according to the clinical protocol, “Good Clinical Practices”, and regulatory requirements to ensure protection and ethical treatment of human subjects;
- Ensure identification and reporting of safety issues, when applicable, from research site staff to the sponsor and the IRB/IEC;
- Perform monitoring activities per the monitoring plan (e.g. verification of source documents and eCRF/CRFs, site communications, follow up on data anomalies, etc.)
- Review accuracy and completeness of site records (i.e., essential documents, query resolution, and other data collection tools);
- Ensure that accountability of Investigational Product and related supplies are performed, when appropriate;
- Ensure complete reporting and proper documentation of monitoring activities;
- Conduct routine monitoring visits (on site or remotely) independently from the investigative site study staff;
- Ensure the site is identifying issues and implementing corrective and preventive actions to ensure inspection readiness.
Upon completion of the course Graduates will be able to:-
- Understand the drug development process and the roles and responsibilities of the CRA.
- Identify ethical issues in clinical research and their impact on the development of new products.
- Institute and obtain proper Informed Consent.
- Understand the latest Good Clinical Practices.
- Learn to employ efficient subject recruitment methods.
- Develop a suitable clinical trial protocol and suitable study budget.
- Identify adverse effects and proper reporting format.
- Appreciate the types of sponsor-investigator site visits
- Analyze and evaluate clinical data, to ensure investigator and site compliance with the protocol.
- Develop qualifications sought by the Pharmaceutical, Biotech & Medical Device industries.
Students will participate in many online simulation exercises during the training program that will expose you to actual monitoring situations such as Investigator Selection, IRB Approval, CRF Review, SDV, Good Clinical Practice and Drug Accountability and Adverse Event assessment.
With the knowledge and job skills gained as a result of your study, you can help to meet the ever-growing demand for trained CRAs to develop exciting new therapeutics for the 21st century in the biotechnology, pharmaceutical and medical device industries.
The CRA certificate is recognized internationally in all the countries that are signatories to the ICH-GCP guidelines for clinical trials. This includes USA, Canada, Israel, Germany, Switzerland, Italy, UK, France, EU countries, Russia, Ukraine, Czech Republic, China, Spain, India, Japan, Hong Kong, Australia, New Zealand, Singapore, Nigeria, South Africa and many others.
Job Placement Assistance:
- As a graduate you will receive assistance to update your resume to include your new qualifications.
- Your resume will have industry-specific terminologies that will guarantee that you get interviews.
- Graduates are routinely referred to employers who contact us regularly when looking to hire CRAs.
- Our graduates are given lifetime access to our exclusive Clinical Research jobs database.
- Recruiters and Employers post their entry-level and other CRA jobs to our exclusive jobs database.
- 100% Online, Self-Paced Training, Start Anytime from Anywhere.
- Completion time - 2 to 3 months studying part-time (2 to 3 hrs per day).
- With intensive study... Actual completion can be as short as 3 to 4 weeks.