CRA training course:
A 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 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.
Essential duties of the CRA include:
- Verify that the research site personnel, including the investigators, are conducting the study according to the clinical protocol, “Good Clinical Practices”, and regulatory requirements;
- Ensure reporting of adverse events from research site staff to the sponsor and the IRB/IEC;
- Verify that the data in the Case Report Forms (CRFs/eCRFs) are in agreement with the source documents (source data verification);
- Review accuracy and completeness of site records (site study file, query resolution, and other data collection tools);
- Verify Investigational Product accountability;
- Complete reporting and ensure management and resolution of all these activities (e.g., visit reports, trial management tracking system);
- Conduct routine monitoring visits on behalf of the clinical trial sponsor.
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, 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.
Training Duration - 250 Hours CEUs
• 100% Online, Self-Paced Training, Start Anytime from Anywhere.
• Average completion time - 2 to 3 months studying part-time.
• With intensive study... actual completion time can be as short as 3-weeks.