CLINICAL TRIAL MONITOR - Qtech-Sol USA offers Clinical Research / Trials, Pharmacovigilance, Drug Safety, Clinical Data Management, Clinical SAS Programming and Healthcare BA Training Programs
Category:
Clinical Research
 
Duration:
6 Weeks / 40 Days
 
 

Clinical Trial Monitor

Introduction – Clinical Trial Monitor

Qtech-Sol specializes in Clinical Science Training, offering a comprehensive program geared towards individuals aspiring to work as Clinical Trial Monitor (CTM). 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 CTM 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 Trial Monitor
(Role based Lessons – Case Scenarios, Job Tasks with Solutions)
Course Code :  CCTM
Course Material : This course contains and delivers 23 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

CCTM-SIP Delivery – 6 Weeks / 40 Days (Self-Paced)

Introduction

A Clinical Trial Monitor (CTM) 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 their primary responsibilities, Clinical Monitors play an essential role as the intermediary between the study’s sponsor, which could be a pharmaceutical company or a contract research organization (CRO), and the clinical sites conducting the research. This crucial position ensures the transparency and integrity of clinical trial results, safeguarding them from any potential undue influence or bias that might arise from the sponsor’s interests.

For a Clinical Monitor to be successful, they must exhibit meticulous attention to detail, possess a robust educational background, and demonstrate effective communication skills when interacting with both sponsor representatives and clinical site staff. Their commitment to maintaining the highest ethical standards and strict adherence to research protocols is vital for the accurate and ethical 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

Monitor (CTM), plays a critical role in the realm of clinical trials, ensuring that the studies are conducted, recorded, and reported per the protocol, Good Clinical Practice (GCP), and relevant regulatory requirements. Their primary goal is to safeguard the rights, safety, and well-being of trial participants while ensuring the integrity and validity of the clinical trial data.

  • Site Monitoring: They conduct regular visits to clinical trial sites to monitor the conduct of the trial, verify the accuracy of the data recorded in case report forms (CRFs), and ensure that the study is conducted in compliance with the protocol and GCP.
  • Regulatory Compliance: They ensure that the trial complies with local and international regulatory requirements, including the management of study documentation and reporting to regulatory authorities as needed
  • Training: Clinical Trial Monitors provide training and support to site staff to ensure that they understand and comply with the trial protocol, GCP, and regulatory requirements.
  • Safety Monitoring: They monitor and report on the safety of participants, ensuring that any adverse events or other safety issues are identified, reported, and addressed promptly.
  • Data Integrity: They verify that the data collected during the trial is accurate, complete, and verifiable against source documents.
  • Communication: As the main point of contact between the sponsor and the trial site, Clinical Trial Monitors facilitate communication, addressing any issues that arise and ensuring that the trial progresses smoothly.

Problem Solving: They identify and resolve issues at trial sites, such as protocol deviations, to ensure compliance and the overall success of the clinical trial.

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

  1. Clinical Monitor
  2. Field Monitor
  3. Clinical Trial Auditor:
  4. Regional Clinical Research Associate
  5. Clinical Study Monitor
  6. Clinical Project Monitor
  7. Clinical Research Monitor

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 Trial Monitor (CTM). The curriculum encompasses both theoretical and practical aspects of these roles, equipping students with the necessary expertise and exposure to meet industry standards.

Clinical Trial Monitor Curriculum
1. Role of CRA Monitoring

2. Drug Discovery And Research Process

3. Pre-Clinical Research

4. Introduction To Clinical Trial

5. Phase-I Clinical Trials

6. Phase-II Clinical Trials

7. Phase-III Clinical Trials

8. Phase-IV Clinical Trials

9. FDA Regulations

10. Good Clinical Practices and ICH Guidelines

11. Institutional Review Board (IRB)

12. SOP Development

13. In-House Monitoring and Reporting

14. Subject Recruitment Process and Informed Consent

15. Source Documentation, Retention and Compliance

16. Drug Accountability Plan

17. Site Visits

18. Site Monitoring

19. Investigator-Monitor Meetings

20. Introduction to Adverse Event Reporting and Classification

21. Understanding Monitoring Worksheets

22. Clinical Trial on Site Audit

23. Study Close Out

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.