Clinical Trials Management | CRA Training
Category:
Clinical Research
 
Duration:
14 Weeks / 475 Hours
 
Price:
$2,540.75 $1,524.45 (CAD)
 
 

Qtech-Sol CRM Certificate Course

Clinical Trials Management

Qtech-Sol is a Clinical Science Training Provider. This course provides a thorough Foundation, Advanced and Project Management related concepts to become a Clinical Study Manager or Senior Clinical Research Associate, focusing on clinical trials, study design, project management, and study monitoring tasks. This is a job and title focused program. The course emphasizes about role of CRA towards protocol design, site initiating, conducting, trial monitoring and managing clinical trials data capture and audits. The course curriculum is designed to give an edge to obtain job as CRA with Pharmaceuticals, Biotech, Medical Device, Clinical Research Organizations (CROs) and with Research Clinics.

Course Name :  Clinical Trials Management
(Role based Lessons – Case Scenarios, Job Tasks with Solutions)
Code :  CRPM
Duration :  14 Weeks / 475 Hours
Delivery: Self-Paced Online with Support.
(Qtech-Sol Learning Management System (Q-LMS)
Course Material : This course contains and delivers 67 Lessons.
This course contains 3 modules spread across 14 weeks to complete.
CRAT – Basic CRA Course – 8 Weeks
CRAP – Clinical Research Tasks as Projects – 4 Weeks
ACRA – Advanced CRA Lessons – 2 Weeks
CRAT Course contains lessons with various delivery modes as presentation with voice over, course reading material (chapters), Quizzes for Practice (15 Set) and Test (10 Set), Short Questions, Role based Tasks (Exercises, along with solutions).
The CRAP and ACRA Courses contains lessons with various delivery modes as presentation and Role based Tasks (Exercises, along with solutions).
Course Brochure : Download BROCHURE
Course Demo : Register for COURSE DEMO
Online Discussion : Book your slot for a personalized ONE-O-ONE discussion with us. You will receive an online invite to participate via email.
Fees : $2,540.75 CAD
Now Only $1,524.45     BUY NOW
Application Form : APPLY NOW
To complete your enrollment, please email your resume to qpdc@qtech-solutions.ca
Introduction

This course emphasizes about clinical trials management concepts, site initiating, conducting, trial monitoring and managing clinical trials data. This training will provide the technical skills and practicum needed to gain expertise. Students get exposed to real-time practices and case studies towards clinical Protocol Development, Case Report forms (CRFs), Trial Master File (TMF), Clinical Trial Management System (CTMS), Clinical Trial Budgeting, Trial Audit process and Monitoring. Insight of GCP-ICH, FDA-EMA SOPs, and Guidelines for conducting Clinical Trials. The course curriculum is designed to give an edge to obtain job opportunities in the clinical research field with Pharmaceuticals, Biotech, Medical Device, Clinical Research Organizations (CROs) and with Research Clinics.

Project Management Concepts: This course includes theoretical concepts from the Project Management Institute, PMBOK® as introductory project management course for the clinical research professional. Whether you are looking to become a clinical research project manager, are already in an entry-level project manager role, or a project manager without formal project training, this hands-on program will provide you with project management skills as well as the necessary tools and processes required to successfully manage projects in clinical research settings.

Course Enrollment process

Qtech-Sol offers self-paced online courses. Student get started with the course when they are ready. They must complete the online application, pay applicable tuition and submit required credentials. Student must submit their resume and copy of highest degree certificate obtained. These documents are used to validate the student’s name on certificate, contact information, course enrolled and their education eligibility to participate.

Start to Finish Steps:
  1. Submit Online Application
  2. Pay applicable tuition (Shopping cart)
  3. Email credentials required
  4. Receive Course Activation email
  5. Obtain access to Course and Solution bank (LMS)
  6. Receive support for subject related queries.
  7. Submit Course task deliveries per schedule shared
  8. Take Final exam upon completing he course
  9. Obtain Course completion certificate and transcript
  10. Get Started with PTA program for next steps
Gaining experience

An Ideal person must have bachelor’s degree in degree in life science or other health-related discipline to become a CRA or CRC. Few entry-level positions (CTA) require Associate or High school diploma. Qtech-Sol CRA Coursework is not wet lab experience, these are computer related roles performed using clinical data and tools, to support the progress of clinical trials being conducted. Person must have basic computer knowledge and works with Microsoft Word, Excel, Notepad, PowerPoint etc. The ideal person works within pharmaceutical or at hospital and research centers.

This course emphasis on basic key role and duties performed. A typical Clinical Research Associate will develop and outline trial protocols, establish trial sites, train site staff, and manage Investigational Product (IP) and trial materials. Students get exposed to real-time practices and case studies towards clinical protocol development, Case Report forms (CRFs), Trial Master File (TMF), Clinical Trial Management System (CTMS), Clinical Trial Budgeting, Trial Audit process and Monitoring. Insight of GCP-ICH, FDA-EMA SOPs, and Guidelines for conducting Clinical Trials.

Few of the advanced topics shared in this course are Risk Based Monitoring (RBM), FDA Audit process for Clinical Research, Clinical Trial Project Management (CTPM) and Timelines, Development of Monitoring Plan, Protocol Deviation/Violation Management, Trial Master File and QC Management, Clinical Data Reconciliation and Archiving, Management and Reconciliation of Investigational Product, Planning and Conducting Global Clinical Trials and Management of a Successful Clinical Research Site.

Examples of job titles to apply
  1. Clinical Study Manager
  2. Clinical Trials Project Manager
  3. Senior Clinical Research Associate
  4. Clinical Trials Project Coordinator
  5. Clinical Research Manager

  • Eligible Education:

    Recommended: An Associate or bachelor’s degree in life science or other health related. Few of the majors accepted for admission into this course are Medicine, Nursing, Pharmacy, Public health, Biology, Biochemistry, Biotechnology, Chemistry, Clinical Research, Biomedical engineering, Public health, Pharmacology, Toxicology and Healthcare Administration. Related Experience helps to apply for higher-up positions.

    Post Training Assistance

    Your resume is front face to hiring recruiters and organizations to pre-screen or call for an interview. With competition out in market, does your resume meet the requirements. Contact us to participate in our Post Training Assistance (PTA) program for resume build, interview narratives, and mock. It is as well important to know, the current hiring organizations in your area, open positions available, salary range, fitness of resume to apply and many more. During this PTA program you will have opportunity to discuss with our course specialist to learn and discover opportunities in small steps. We shall work together as team to achieve this goal.

  • Learning Outcomes:
    The Benefit Student Gains
    • Upgrading the Knowledge required.
    • Better Resume Placement for promising jobs.
    • Low Investment, high learnings
    • Learn from Anywhere, Anytime at your pace.
    • Job and Title Based Tasks as followed and Practiced in industry
    • Applying Concept into Real-time (Policies, governance and tools)
    • Work on Role Based Tasks followed and Practiced in industry
    • Mocks and Narratives for Client Discussions
    • Readiness to work with limited support
  • Professional organizations

    Professional organizations and associations are membership-based groups comprised of people working in a similar field. They can be helpful resources for students to learn more about a field, develop connections and discover related opportunities.

    Check out World-Wide Clinical Resource Information. Follow the resource links to learn what’s happening around the world on current news and updates about Clinical trials, Regulatory, CDM and Pharmacovigilance.

    Reviews

    Qtech-Sol has trained since 2000, many candidates with different education background and skills. Few of them are currently working as directors in top MNC companies.

    Qtech Solutions has provided me with the education needed to work as a Clinical Research Associate. The program was extremely helpful and the instructions were very knowledgeable.

    – Akhila T (Surrey, BC)

    It was a very interesting CRA training course. Topic, professional presentation, Quiz and test, makes the difference between a good training session and a GREAT training session. I like the competent materials course.

    – Charith A (Mississauga, ON)

    The level and nature of participation was simply exceptional, concrete exercise, excellent analysis and feedback. The work assigned to interns is valuable and very useful. This CRA training is a value addition program and helps me to face the global opportunities.

    – Harshavardhan A (Abbotsford, BC)

    Getting Connected

    For additional information please call us on 905.519.0889 or ENQUIRE. One of our course specialists will contact you at earliest possible.

Curriculum Overview

Program is designed by industry experts meeting job and title-based learnings needed for students and young professionals to get into jobs. The training provides in depth knowledge of roles and responsibilities of Clinical Study Manager (or) Senior Clinical Research Associate / Coordinator. The curriculum includes theoretical and practical aspect of the role and tasks performed on day-to-day basis, along with exposure to various exercises per industry requirements Manager. It gives insight into topics.

Clinical Trials Management
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

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

CRAP – Clinical Research Tasks- Projects

1) Clinical Trial Budget

2) Investigator Selection

3) Pre-Study Visit

4) Protocol

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

15) Audit

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

Getting Connected

For additional information please call us on 905.519.0889 or ENQUIRE. One of our course specialists will contact you at earliest possible.

  • I am very thankful to Q tech learning center team for providing training in Clinical Research Project Management (CRPM), as it will be helpful for me to gain experience in real-time.

    Paul A

  • The training helped me enhance my skills. The training was given in a very well planned, organized and professional manner.

    Neepa Y

  • The program was extremely helpful and the instructions were very knowledgeable. Thank you very much.

    Lily W