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Unique intensive, fast-track and accelerated training program offered in combination of online self-paced format and weekly virtual lectures and typically run for 8 weeks. Led by expert instructors with real-world experience. It explores topics relevant to Aspiring Clinical Research Associates (CRAs), Aspiring Clinical Research Coordinators (CRCs) and Nurses, College Students and New Graduates in a Scientific Field, Clinical Research Professionals who don’t have experience in the USA, Canada and European Countries, International Medical Doctors and Pharmacists who want to pursue this in high demand career.
Our Advanced Clinical Research Associate (CRA) Training Program is designed to provide you with the in-depth knowledge, skills, and experience needed to excel in the ever-evolving clinical research industry. Delivered in a blended learning format, this program combines the flexibility of self-paced online modules with the interactive benefits of weekly virtual lectures , ensuring that participants can learn at their own pace while still receiving guidance and mentorship from industry experts. Why It's Important to Enroll in Our Program: Comprehensive, Industry-Relevant Training : The course content is focusing on advanced topics such as site management, trial documentation, regulatory compliance, and monitoring strategies in specialized therapeutic areas. Blended Learning for Flexibility and Engagement : With a blend of self-paced online learning and real-time virtual lectures, this program accommodates busy schedules while offering opportunities to interact with instructors, ask questions, and engage in discussions on complex topics. Real-World Application and Hands-On Exercises : Participants will engage in hands-on, practical exercises and scenarios that simulate real-world clinical research monitoring activities, such as site initiation visits, source data verification, and managing protocol deviations. Expert Instructors and Industry Insights : The program is taught by highly experienced industry professionals who provide insider knowledge, current trends, and mentorship throughout the course. You will gain access to experts who understand the latest regulatory updates and clinical trial methodologies.
Upon successful completion of the Advanced CRA Training Program, participants will be able to:
Master Advanced Monitoring Techniques
Effectively monitor clinical trials, including patient safety, protocol compliance, and data integrity in both early and late-phase trials.
Understand Complex Regulatory Requirements
Demonstrate a thorough understanding of international regulatory frameworks (FDA, EMA, ICH GCP) and how they apply to clinical trials, including documentation, reporting, and compliance.
Manage Trial Sites Efficiently
Lead and manage site initiation, monitoring, and close-out visits, ensuring effective communication with site staff and proper management of investigational product (IP) accountability.
Solve Real-World Issues in Clinical Trials
Identify and address challenges that arise during clinical trials, such as protocol deviations, adverse event reporting, and develop expertise in monitoring complex clinical trials.
An overview of the clinical research process, including the drug development lifecycle, roles and responsibilities of CRA & CRC and different stakeholders, and the importance of ethical considerations
In-depth training on GCP principles, regulations, and standards that ensure the integrity and quality of clinical trials. This includes topics such as patient safety, informed consent, protocol adherence, data management, and adverse event reporting
In depth knowledge on drug development lifecycle including, preclinical phase, Investigational New Drug (IND) Application, phases of clinical trials, New Drug Application (NDA), Regulatory review and approval and post-marketing surveillance
Exploring the regulatory requirements and ethical considerations that govern clinical research, including Institutional Review Boards (IRBs), informed consent processes, and the responsible conduct of research
Detailed information about the operational aspects of clinical trials, such as site selection, investigator recruitment, study budgeting, monitoring visits, source data verification
Site initiation, routine monitoring visits and close-out visits
Regulatory and subject Documents; drug storage, documentation, and accountability requirements
Introduction to risk-based approaches in clinical trial monitoring, Identifying and mitigating risks
Understanding how clinical study protocols are developed, including the objectives, study design, eligibility criteria, endpoints, and statistical considerations. Emphasis is placed on the importance of protocol compliance during the trial
Understanding adverse event reporting, safety monitoring, and pharmacovigilance procedures. This includes knowledge of safety databases, adverse event assessment, and regulatory reporting requirements
Learning about quality assurance processes, including internal and external audits, quality control measures, and compliance monitoring. This ensures adherence to regulations, protocols, and standard operating procedures
Introduction to project management principles, including study timelines, resource allocation, risk assessment, and effective communication within a clinical research team
Guidance on career paths within clinical research, professional development opportunities
offers a robust and flexible learning environment that prepares participants for the complexities of clinical trial monitoring. The blend of self-paced modules and virtual lectures provides the perfect combination of convenience, real-time support, and interactive learning. With a strong focus on practical skills and real-life scenarios, this program is essential for candidates seeking to advance their careers and working as a CRA or CRC.
