Advanced Clinical Research Associate | CRA Training
Category:
Clinical Research
 
Duration:
2 Weeks / 14 Days
 
 

ADVANCED CLINICAL RESEARCH

Introduction – Advanced Clinical Research

At Qtech-Sol, we specialize in Clinical Science Training, and our advanced program is meticulously designed for individuals who aspire to excel as Advanced Clinical Research Associates (CRAs) and take on pivotal roles in clinical trial management. Our program goes beyond the fundamentals, focusing on equipping students with the specialized skills and knowledge required for this elevated responsibility.

Senior Clinical Research Associates (CRAs) are pivotal figures in clinical trial management, performing critical duties that drive the success of these crucial endeavors. They actively engage in the development and rigorous review of clinical trial protocols to ensure meticulous compliance with regulatory standards. Additionally, Senior CRAs play a vital role in the meticulous selection and evaluation of trial sites, ensuring they are well-prepared for participation.

Education and training are essential responsibilities for Senior CRAs, as they lead efforts to instruct investigators and site personnel on the intricacies of trial protocols. Patient safety remains a paramount concern for Senior CRAs, who actively monitor patient well-being, respond promptly to adverse events, and ensure the comprehensive documentation and reporting of these critical incidents.

Data management is a critical aspect of their role, with Senior CRAs overseeing data collection and maintaining data integrity and quality throughout the trial. They work closely with data management teams to achieve these objectives. Senior CRAs significantly contribute to patient recruitment and retention strategies, working tirelessly to meet enrollment goals and minimize patient dropouts. In their capacity as Senior CRAs, these seasoned professionals bring invaluable expertise to clinical trial management, ensuring patient safety, data quality, and protocol adherence, all of which are essential for the successful outcomes of clinical trials. Additionally, they excel in risk management, proactively identifying potential risks and formulating mitigation strategies to ensure the seamless progression of the clinical trial. Furthermore, they oversee the closeout process, ensuring the comprehensive completion of all trial documentation and the proper closure of sites following regulatory standards.

Course Name :  Advanced Clinical Research
(Role based Lessons – Case Scenarios, Job Tasks with Solutions)
Course Code :  ACRA
Course Material : This course contains and delivers 15 Lessons.
Every lesson encompasses diverse delivery methods, including
  1. Narrated Presentations: Engaging presentations accompanied by voiceovers to enhance comprehension.
Delivery Type

SIP – Self-Paced Online with Support

Course Duration

ACRA-SIP Delivery – 2 Weeks / 14 Days (Self-Paced)

Introduction

A Senior Clinical Research Associate (CRA) plays a pivotal role in the management of clinical trials and studies associated with pharmaceutical and biotechnological products, medications, and medical procedures. Their responsibilities encompass a wide range of tasks, including:

  1. Protocol Development: Actively participating in the development and review of trial protocols to ensure compliance with regulations.
  2. Site Selection: Assessing and selecting suitable trial sites.
  3. Investigator Training: Educating investigators and site staff on protocol requirements.
  4. Monitoring: Conducting rigorous site visits to ensure adherence to protocols and data accuracy.
  5. Patient Safety: Monitoring and responding to adverse events, ensuring proper documentation and reporting.
  6. Regulatory Compliance: Ensuring timely and accurate submission of regulatory documents.
  7. Data Management: Overseeing data collection, integrity, and quality.
  8. Quality Control: Implementing quality control measures through audits and assessments.
  9. Patient Recruitment: Contributing to recruitment and retention strategies.
  10. Communication: Facilitating effective communication among stakeholders.

Senior CRAs play a vital role as a bridge between the study’s sponsor (often a pharmaceutical company or CRO) and clinical sites. This intermediary role is critical for maintaining transparency and result integrity, free from sponsor bias. Success in this role demands exceptional attention to detail, a strong education, and effective communication with both sponsors and clinical staff. Upholding research ethics and protocol adherence is essential for successful clinical trial execution.

Course Enrollment process

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

Building Relevant Experience as a Senior Clinical Research Associate (CRA) is a journey that involves critical responsibilities at the core of clinical trial management. These key duties are instrumental in accumulating the expertise needed to excel in this pivotal role.

One of the primary aspects of building relevant experience is active involvement in the development and thorough review of clinical trial protocols. This hands-on engagement ensures a deep understanding of protocol intricacies and compliance with stringent regulatory guidelines. Additionally, it is essential to participate in the meticulous selection and evaluation of trial sites, honing the ability to assess site readiness and suitability.

Another crucial element in accumulating relevant experience is the role of educating and training investigators and site staff on protocol intricacies. This instructional role not only cultivates a strong commitment to protocol adherence but also sharpens communication and leadership skills. Rigorous monitoring visits to clinical sites are an integral part of the journey, offering invaluable exposure to data review, verification, and the vital aspects of protocol compliance and regulatory standards.

Patient safety remains paramount during this experience-building process, as Senior CRAs actively monitor patient well-being, respond swiftly to adverse events, and ensure the accurate documentation and reporting of these incidents. The journey also involves mastering regulatory compliance, with a focus on timely and precise submission of documents to maintain adherence to regulatory standards. Expertise in data management, quality control, and assurance, along with active participation in patient recruitment and retention strategies, contribute significantly to this journey.

Effective communication, both with sponsors and site personnel, is a cornerstone, fostering collaboration and refining problem-solving skills. As part of the experience-building process, Senior CRAs also excel in risk management, proactively identifying potential risks and developing mitigation strategies to ensure the smooth progression of clinical trials. Lastly, overseeing the closeout process is an essential skill, ensuring that all trial documentation is complete and sites are properly closed in compliance with regulatory standards.

In summary, building relevant experience as a Senior Clinical Research Associate is a multi-faceted journey that involves mastering critical responsibilities within clinical trial management. It encompasses protocol development, site selection, investigator training, monitoring, patient safety, regulatory compliance, data management, quality assurance, recruitment and retention, communication, risk management, and closeout processes. These experiences collectively prepare individuals to excel in the role and contribute effectively to the success of clinical trials.

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

Educational Requirements:

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.

Support After Training:

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.
Professional Organizations and Associations:

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.

Overview of the Curriculum

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.

Advanced Clinical Research
ACRA – Advanced CRA Course Modules

1. Risk-Based Monitoring (RBM)

2. FDA Audit process for Clinical Research

3. Clinical Trial Project Management (CTPM)

4. Development of Monitoring Plan

5. Protocol Deviation/Violation Management

6. Trial Master File and QC Management

7. Clinical Data Reconciliation and Archiving

8. Management and Reconciliation of Investigational Products

9. Advanced Clinical Research Management -1

10. Advanced Clinical Research Management -2

11. Advanced Clinical Research Management -3

12. Advanced Clinical Research Management -4

13. Planning and Conducting Global Clinical Trials

14. Management of a Successful Clinical Research Site – A

15. Management of a Successful Clinical Research Site – B

Our program not only delves into the core competencies required for advanced CRA roles but also integrates PMI project management principles to enhance students’ project planning and execution capabilities in clinical research. This comprehensive curriculum is tailored to provide students with a strong foundation, enabling them to excel in a competitive job market and embark on successful careers in clinical research and project management.

Getting in Touch:

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.