CLINICAL TRIAL PROJECTS (CRA ROLE BASED)

CLINICAL TRIAL PROJECTS (CRA ROLE BASED)

Qtech-Sol specializes in Clinical Science Training, offering a comprehensive program geared towards individuals aspiring to work as Clinical Research Associates (CRAs) or Clinical Research Coordinators (CRCs). Our course is meticulously structured to provide a strong foundation and practical skills necessary to meet job roles.

The program places a strong emphasis on the pivotal role of CRAs in various aspects of clinical research, including protocol design, site initiation, trial conduct, ongoing monitoring, and effective management of clinical trial data capture and audits. Our curriculum is strategically crafted to provide students with a competitive advantage in securing employment opportunities as CRAs within the pharmaceutical, biotechnology, medical device, clinical research organizations (CROs), and research clinic sectors.

1. Narrated Presentations: Engaging presentations accompanied by voiceovers to enhance comprehension.
2. Role-Based Tasks: Practical exercises tailored to specific roles, accompanied by detailed solutions for comprehensive learning.

SIP – Self-Paced Online with Support

CRAP-SIP Delivery – 11 Weeks / 260 Hours (Self-Paced)

As individuals aspire to become Senior Clinical Research Associates (CRA), they undergo a comprehensive role-based training program designed to equip them with the essential knowledge and skills required for success in this pivotal role. This training is divided into distinct groups, each concentrating on specific aspects of clinical trial management.

In the first phase, known as “Pre-Trial Preparation,” trainees take on the role of Pre-Trial Coordinators. Their primary responsibilities revolve around establishing the foundational groundwork for successful clinical trials. This phase covers a wide range of critical tasks, including budget management, investigator selection, pre-study visits, protocol adherence, informed consent preparation, Investigational New Drug (IND) application processes, and navigating the intricacies of Institutional Review Board (IRB) correspondence. Pre-Trial Coordinators are tasked with ensuring that the groundwork for the clinical trial is meticulously laid out, from ethical considerations to regulatory compliance.

The second phase, termed “On-Trial Operations,” sees trainees assume the role of On-Trial Monitors. In this stage, their main duty is to oversee the ongoing execution of clinical trials in real-time. Training in this group includes the review and verification of Case Report Forms (CRFs), site monitoring activities, collaboration with fellow monitors in co-monitoring visits, and the facilitation of study initiation visits. On-Trial Monitors play a crucial role in maintaining the integrity and accuracy of clinical trial data.

Moving forward, the “Trial Management and Documentation” phase introduces individuals to the role of Trial Management Specialists. Here, trainees learn to manage essential trial documentation and systems effectively. They become proficient in the utilization of Clinical Trial Management Systems (CTMS) to streamline trial operations, maintain a meticulous Trial Master File, and understand the procedures involved in database locking. Trial Management Specialists are responsible for ensuring that all trial documentation and records are organized, complete, and accessible.

In the final phase, “Post-Trial Compliance,” individuals assume the role of Post-Trial Auditors. This phase focuses on post-trial quality assurance and compliance. Post-Trial Auditors are trained to conduct comprehensive audits of trial documentation, ensuring that all processes and records conform to rigorous regulatory standards and best practices. They play a vital role in ensuring the integrity and credibility of clinical trial results.

This structured and role-based training classification equips aspiring Senior Clinical Research Associates with the expertise needed at different stages of clinical trial management. It empowers them to contribute effectively to the advancement of medical research and the development of transformative medical treatments.

Qtech-Sol offers a flexible approach to learning through our self-paced online courses. Students have the freedom to commence their studies at their convenience, following a straightforward process.

1. Member Registration: Begin by registering as a member of our platform
2. Course Selection: Explore and choose the course that best suits your needs and goals.
3. Enrollment and Tuition: Complete the enrollment process and make the necessary tuition payment.
4. Access Learning Materials: Access course materials and resources through our Learning Management System (LMS).
5. Support and Assistance:Receive support and assistance via email or schedule Google Meet sessions through the LMS.
6. Course Task Submissions:Submit course-related tasks and assignments as per the provided schedule.
7. Final Examination:Upon finishing the course, take the final examination to demonstrate your understanding.
8. Course Completion:Upon successful completion, receive a course completion certificate and a transcript.
9. Post-Training Support:Take advantage of our post-training support for assistance with resume building, narrative development, and mock interviews.

This step-by-step process ensures a smooth and flexible learning experience, allowing you to acquire valuable skills and knowledge at your own pace.

Building relevant experience as an aspiring Senior Clinical Research Associate involves a structured training program divided into distinct phases. In the ‘Pre-Trial Preparation’ phase, trainees become proficient in budget management, investigator selection, protocol adherence, and other foundational tasks. The ‘On-Trial Operations’ phase focuses on real-time oversight of clinical trials, including data verification and site monitoring. As trainees progress to ‘Trial Management and Documentation,’ they gain expertise in managing trial documentation and systems. Finally, in the ‘Post-Trial Compliance’ phase, individuals learn to conduct comprehensive audits to ensure regulatory compliance and data integrity. This role-based training approach equips aspiring CRAs with the skills needed to excel in clinical trial management and contribute to medical research.

This comprehensive training equips aspiring professionals with the skills and knowledge needed to thrive in the dynamic field of clinical research.

Preferred Qualifications: A candidate with an associate or bachelor’s degree in life sciences or a related health field is highly recommended for admission into this course. Some of the eligible majors for enrollment include Medicine, Nursing, Pharmacy, Public Health, Biology, Biochemistry, Biotechnology, Chemistry, Clinical Research, Biomedical Engineering, Pharmacology, Toxicology, and Healthcare Administration.

Your resume is often the first impression you make on recruiters and potential employers. In today’s competitive job market, it’s crucial to ensure that your resume meets industry standards and effectively represents your qualifications. That’s where our Post-Training Assistance (PTA) program comes in.

Our PTA program offers valuable assistance in resume building, interview preparation, and mock interviews. It’s not just about creating a strong resume; it’s also about understanding the current job market in your area, identifying available positions, gauging salary ranges, and ensuring that your resume aligns with your career goals. During the PTA program, you’ll have the opportunity to engage with our course specialists, taking small but meaningful steps toward your professional success. We’ll work together as a team to help you achieve your career objectives.

   Key Learning Outcomes and Benefits for Students:

1. Enhancing the knowledge and skills required for your field.
2. Improving your resume to increase your chances of landing promising job opportunities.
3. High-value learning at an affordable cost.
4. Flexibility to learn from anywhere, at your own pace.
5. Practical tasks aligned with real-world industry practices and job roles.
6. Application of concepts in real-time scenarios, including policies, governance, and industry tools.
7. Engaging in role-based tasks commonly practiced in the industry.
8. Preparation with mock interviews and interview narratives for effective client discussions.
9. Readiness to work with minimal support, boosting your confidence in your chosen field.

Consider joining professional organizations and associations related to your field. These groups offer valuable networking opportunities, resources, and insights from fellow professionals. They can help you stay updated on industry trends and discover new career prospects.

Stay Informed:

Explore global clinical resource information to stay informed about the latest news and updates in areas like clinical trials, regulatory matters, clinical data management (CDM), and pharmacovigilance.

Our Advanced Clinical Research Associate (CRA) program is meticulously designed by industry experts to equip students and young professionals with the knowledge and skills required to excel in the field. This curriculum focuses on job and title-based learning, providing comprehensive insights into the roles and responsibilities of a Clinical Study Manager or Senior Clinical Research Associate, specifically in the context of conducting and managing multinational clinical trials. Additionally, the program integrates essential project management concepts from the Project Management Institute (PMI) to enhance students’ abilities in planning and executing clinical projects.

For more information, please call us at +1 905.228.9698 / +1 905.519.0889 (WhatsApp) or email qpdc@qtech-solutions.ca. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.