24 Weeks / 180 Days
Clinical Trials Management
Qtech-Sol is a leading provider of Clinical Science Training. Our comprehensive program offers a robust foundation, advanced knowledge, and project management expertise essential for individuals aspiring to excel as Clinical Study Managers or Senior Clinical Research Associates. This specialized training program delves deep into clinical trials, study design, project management, and study monitoring tasks, making it ideal for those seeking career growth and specific job titles.
Key Highlights of Our Program:
Job and Title Focus: Our program is meticulously designed to align with specific job roles and titles in the industry.
- Emphasis on the Role of CRA: We place a strong emphasis on the Clinical Research Associate’s (CRA) pivotal role, including protocol design, site initiation, trial conduct, monitoring, and the meticulous management of clinical trial data capture and audits.
- Diverse Opportunities: The curriculum equips individuals with the knowledge and skills needed to secure positions as CRAs within Pharmaceuticals, Biotechnology, Medical Device companies, Clinical Research Organizations (CROs), and Research Clinics.
- Comprehensive Coverage: Our program covers a wide range of topics, from foundational concepts to advanced project management techniques, ensuring that students are well-prepared to excel in their chosen roles.
By enrolling in our program, you’ll gain a competitive edge and enhance your prospects of securing rewarding positions in the clinical research field.
(Role based Lessons – Case Scenarios, Job Tasks with Solutions)
Course Overview: This comprehensive course comprises a total of 67 lessons, organized into three distinct modules, designed to be completed over a span of 16 weeks.
- CRAT – Basic CRA Course: This module includes lessons delivered in various formats, such as narrated presentations, course reading materials (chapters), quizzes for practice (15 sets), tests (10 sets), short questions, and role-based tasks with accompanying solutions.
- CRAP – Clinical Research Tasks as Projects: In this module, lessons are primarily presented in a narrated presentation format, along with role-based tasks and their respective solutions.
- ACRA – Advanced CRA Lessons: The ACRA module also offers lessons in narrated presentation format, supplemented by role-based tasks and solutions
This course structure ensures a comprehensive learning experience, allowing students to build a strong foundation and progress to more advanced topics in the field of clinical research.
SIP – Self-Paced Online with Support
CTSD-SIP Delivery – 16 Weeks / 120 Days
This course places a strong emphasis on the core principles of clinical trials management, covering essential areas such as site initiation, trial conduct, monitoring, and the effective management of clinical trial data. Through this training, students will acquire the technical skills and practical knowledge required to excel in the field. The curriculum offers real-world exposure, including hands-on experiences and case studies related to clinical protocol development, Case Report Forms (CRFs), Trial Master Files (TMFs), Clinical Trial Management Systems (CTMS), clinical trial budgeting, trial audit processes, and monitoring. Additionally, students will gain insights into Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, FDA-EMA Standard Operating Procedures (SOPs), and industry guidelines for conducting clinical trials.
Our course is strategically designed to provide a competitive advantage, enhancing your job prospects within the clinical research industry, whether you aspire to work with Pharmaceuticals, Biotechnology firms, Medical Device companies, Clinical Research Organizations (CROs), or Research Clinics.
In addition to clinical research-specific content, this program also incorporates key project management concepts derived from the Project Management Institute’s PMBOK®. It serves as an introductory project management course tailored for professionals in the clinical research field. Whether you are aiming to become a clinical research project manager, are currently in an entry-level project management role, or have limited formal project training, this hands-on program equips you with the essential project management skills, tools, and processes necessary to successfully oversee projects within clinical research settings.
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.
- Member Registration: Begin by registering as a member of our platform
- Course Selection: Explore and choose the course that best suits your needs and goals.
- Enrollment and Tuition: Complete the enrollment process and make the necessary tuition payment.
- Access Learning Materials: Access course materials and resources through our Learning Management System (LMS).
- Support and Assistance: Receive support and assistance via email or schedule Google Meet sessions through the LMS.
- Course Task Submissions: Submit course-related tasks and assignments as per the provided schedule.
- Final Examination: Upon finishing the course, take the final examination to demonstrate your understanding.
- Course Completion: Upon successful completion, receive a course completion certificate and a transcript.
- 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.
Tailored for Clinical Study Manager Role:
To pursue a career as a Clinical Study Manager, the educational requirements vary depending on the specific position and employer. Typically, a strong foundation for this role includes at least a bachelor’s degree in a life science or a related health discipline.
At Qtech-Sol, we offer specialized training that aligns with the demands of the Clinical Study Manager role. Our coursework doesn’t involve traditional wet lab experience but instead focuses on computer-related responsibilities that leverage clinical data and tools to oversee and support ongoing clinical trials. Therefore, a fundamental understanding of computer applications such as Microsoft Word, Excel, Notepad, and PowerPoint is essential for success in this capacity.
The preferred candidate for the Clinical Study Manager role often comes with prior experience in the pharmaceutical industry, healthcare institutions, or research centers. Our course curriculum is designed to emphasize the fundamental key roles and duties performed by Clinical Study Managers, including the development of trial protocols, the establishment of trial sites, training of site staff, and the effective management of Investigational Products (IP) and trial materials.
Students enrolled in our program gain invaluable practical exposure to real-time industry practices and engage in case studies that relate to clinical protocol development, Case Report Forms (CRFs), Trial Master Files (TMFs), Clinical Trial Management Systems (CTMS), clinical trial budgeting, trial audit processes, and monitoring. Additionally, our coursework provides insight into essential aspects such as Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, FDA-EMA Standard Operating Procedures (SOPs), and industry-specific guidelines governing the execution of clinical trials.
Moreover, our course extends into advanced topics that are directly relevant to the Clinical Study Manager role. These include Risk-Based Monitoring (RBM), the FDA Audit process for Clinical Research, Clinical Trial Project Management (CTPM) and the associated timelines, the development of Monitoring Plans, Protocol Deviation/Violation Management, Trial Master File and Quality Control Management, Clinical Data Reconciliation and Archiving, Management and Reconciliation of Investigational Products, Planning and Conducting Global Clinical Trials, and the successful oversight of Clinical Research Sites.
By completing our program, you’ll be well-prepared to take on the role of a Clinical Study Manager and excel in this rewarding career within the clinical research field.
The educational qualifications and experience levels required to become a Clinical Study Manager can vary depending on the employer, specific job role, and the complexity of the clinical trials being managed. Here’s a general overview of the typical qualifications and experience levels:
Bachelor’s Degree: Many Clinical Study Manager positions require at least a bachelor’s degree in a relevant field, such as life sciences, biology, pharmacy, nursing, or a related health discipline. This is typically the minimum educational requirement.
Master’s Degree: Some employers may prefer candidates with a master’s degree in a relevant field, especially for more senior or specialized positions.
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:
- Enhancing the knowledge and skills required for your field.
- Improving your resume to increase your chances of landing promising job opportunities.
- High-value learning at an affordable cost.
- Flexibility to learn from anywhere, at your own pace.
- Practical tasks aligned with real-world industry practices and job roles.
- Application of concepts in real-time scenarios, including policies, governance, and industry tools.
- Engaging in role-based tasks commonly practiced in the industry.
- Preparation with mock interviews and interview narratives for effective client discussions.
- 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.
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 program has been meticulously crafted by industry experts to provide students and young professionals with the specialized knowledge and skills required for career opportunities as Clinical Study Managers, Senior Clinical Research Associates, or Coordinators. Our curriculum encompasses both theoretical and practical aspects of these roles, ensuring that students are well-prepared for their day-to-day responsibilities and industry requirements.
|Clinical Trials Management / Clinical Study Manager
CRAT – Basic CRA Lessons
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
11.Institutional Review Board (IRB)
12. Overview of Clinical Protocol
13.Clinical Protocol Design and 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
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
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
CRAP – Clinical Research Tasks- Projects
1) Clinical Trial Budget
2) Investigator Selection
3) Pre-Study Visit
5) Informed Consent Preparation
6) Investigational New Drug (IND) Application
7) Institutional Review Board (IRB) Regulatory Correspondence
8) Case Report Form (CRF)
9) Site Monitoring
10) Co-Monitoring Visits
11) Study Initiation Visit
12) Clinical Trial Management Systems (CTMS) Tracking Recording
13) Trial Master File
14) Database Lock
ACRA – Advanced CRA Lessons
1) Risk Based Monitoring (RBM)
2) FDA Audit process for Clinical Research
3) Clinical Trial Project Management and Time-lines
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 Product
9) Advanced Clinical Research Management
10) Planning and Conducting Global Clinical Trials
11) Management of a Successful Clinical Research Site
This comprehensive program equips students with the knowledge and skills needed to excel in clinical research roles and meet the demands of the industry.
For more information, please call us at +1 732.770.4100 / +1 732.207.4564 (WhatsApp) or email email@example.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.