Clinical Research Associate | CRA Training
Category:
Clinical Research
 
Duration:
10 Weeks / 67 Days
 
 

Clinical Research Associate

Introduction – Clinical Research Associate

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 for these 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.

Course Name :  Clinical Research Associate
(Role based Lessons – Case Scenarios, Job Tasks with Solutions)
Course Code :  CRAT
Course Material : This course contains and delivers 41 Lessons.
Every lesson encompasses diverse delivery methods, including
  1. Narrated Presentations: Engaging presentations accompanied by voiceovers to enhance comprehension.
  2. Course Reading Material: Comprehensive chapters designed to facilitate an in-depth understanding of the subject matter.
  3. Practice Quizzes: A set of 15 quizzes to reinforce learning and assess your progress.
  4. Assessment Tests: Ten different test sets to evaluate your grasp of the material.
  5. Short Questions: Succinct questions to encourage critical thinking and quick recall.
  6. Role-Based Tasks: Practical exercises tailored to specific roles, accompanied by detailed solutions for comprehensive learning.
Delivery Type

SIP – Self-Paced Online with Support

Course Duration

CRAT-SIP Delivery – 10 Weeks / 67 Days (Self-Paced)

Introduction

A 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. Participant Recruitment: Identifying and enrolling suitable study participants.
  2. Data Collection: Gathering and recording patient data in a meticulous manner.
  3. Study Documentation: Crafting and maintaining essential study documents.
  4. Quality Assurance Audits: Conducting thorough assessments to ensure adherence to study protocols and quality standards
  5. Report Compilation:Compiling and finalizing reports derived from extensive, long-term clinical trials.

In addition to these core functions, CRAs serve as a vital link between the study’s sponsor, often a pharmaceutical company or contract research organization (CRO), and the clinical sites where the research is conducted. This intermediary role is crucial in maintaining the transparency and integrity of clinical trial results, ensuring that they remain free from any undue influence or bias associated with the sponsor’s interests.

To excel in this role, a successful CRA must possess exceptional attention to detail, a high level of education, and the ability to communicate effectively with both sponsor representatives and clinical personnel. Their dedication to upholding the highest standards of research ethics and protocol adherence is paramount to the successful execution of clinical trials.

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

To embark on a career in clinical research, individuals should ideally possess a bachelor’s degree in life sciences or a related health discipline. However, some entry-level roles, such as Clinical Trial Assistants (CTAs), may only require an associate degree or even a high school diploma. Qtech-Sol’s CRA Coursework focuses on computer-based roles that leverage clinical data and tools to support the progression of ongoing clinical trials. Therefore, a fundamental understanding of basic computer applications like Microsoft Word, Excel, Notepad, and PowerPoint is essential for success in this field.

The ideal candidate for these roles typically has a background in pharmaceuticals, healthcare, or research centers, including hospitals. This course places significant emphasis on the key responsibilities performed by Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs). These professionals are responsible for developing and outlining trial protocols, establishing trial sites, providing training to site staff, and managing Investigational Products (IP) and trial materials. Students enrolled in our program gain exposure to real-world practices and case studies, which encompass aspects such as clinical protocol development, Case Report Forms (CRFs), Trial Master Files (TMFs), Clinical Trial Management Systems (CTMS), clinical trial budgeting, trial audit processes, and monitoring. Furthermore, students gain insight into Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, FDA-EMA Standard Operating Procedures (SOPs), and regulations governing the conduct of clinical trials.

Upon successful completion of our program, individuals can explore various job titles, including but not limited to:

  1. Clinical Research Associate (CRA)
  2. Clinical Research Coordinator (CRC)
  3. Clinical Trial Assistant (CTA)
  4. Research Associate (RA)
  5. Clinical Trial Management System Assistant (CTMS)
  6. Trial Master File Associate (TMF)

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 program has been meticulously crafted by industry experts to provide students and young professionals with the essential knowledge and skills needed to pursue careers in the field. It offers a comprehensive understanding of the roles and responsibilities associated with Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs). The curriculum encompasses both theoretical and practical aspects of these roles, equipping students with the necessary expertise and exposure to meet industry standards.

Clinical Research Associate Curriculum
1. Drug Discovery and Research Process

2. Pre-Clinical Research

3. Introduction to Clinical Trials

4. Role of Clinical Research Associate

5. Phase I Clinical Trials

6. Phase II Clinical Trials

7. Phase III Clinical Trials

8. Phase IV Clinical Trials

9. Good Clinical Practice and ICH Guidelines

10.FDA Regulations

11.Institutional Review Board (IRB)

12. Overview of Clinical Protocol

13.Clinical Protocol Design and Development

14.SOP Development

15.Case Report Form (CRF) Design

16.Clinical Trial Budget

17.Conducting Multinational Clinical Trials

18.Communication- Cross-Functional Team

19.CRA / CRC – In House Responsibilities

20.Selection of Investigator

21.Vendor Selection and Management

22.Informed Consent Preparation

23.Roles and Responsibilities of the Investigator

24.Investigator Meetings and Timelines

25.Selection of Investigator Site

26.Study Initiation

27.In-House Monitoring and Reporting

28.Trial Master File (TMF)

29.Introduction- AE Reporting

30.Preparation for Internal Audit

31 Role of CRA Monitoring

32.Subject Recruitment Process and Informed Consent

33.CRF Design and Development Monitoring Perspective

34.Source Documentation, Retention and Compliance

35. Drug Accountability Plan

36.Site Visits

37.Site Monitoring

38.Investigator-Monitor Meetings

39.Understanding Monitoring Worksheets

40.Clinical Trial and Site Audit

41. Study Close-Out

Job focused exercises

Case 1: Introduction to Clinical Trial

Case 2: FDA EMEA Regulations

Case 3: Institutional Review Board (IRB)

Case 4: Protocol Design and Development

Case 5: Clinical Trial Budget

Case 6: Case Report Form (CRF) Design

Case 7: Investigator Meeting

Case 8: Site Management and Initiation

Case 9: Informed Consent Preparation

Case 10: Trial Master File

Case 11: Adverse Event Monitoring and Reporting

Case 12: Audit

Getting in Touch:

For more information, please call us at +1 732.770.4100 / +1 732.207.4564 (WhatsApp) or email qpdc@qtech-solutions.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.