This program is currently being reviewed by the Private Training Institutions Branch (PTIB) of the Ministry of Advanced Education, Skills & Training for approval.
The course provides a thorough Foundation, Advanced and Project Management related concepts focusing clinical trials, drug development, Study design, Project Management, and Monitoring concepts of Clinical Sciences in reference to roles and responsibilities performed by Clinical Research Associate. The concepts include a protocol development, assessment and reporting of adverse events and explains GCP-ICH guidelines along with other necessary regulatory information. The course emphasizes on understanding of the science and the expectations of initiating, conducting, monitoring, and managing clinical trial related work. This training will develop the technical skills and knowledge pertaining to roles and responsibilities of CRA – In House. Students will get exposure to real time practices pertaining to Case Report forms (CRFs), Trial Master File (TMF), Clinical Trial Protocol, Clinical Trial Budget, and Audit. The course curriculum is designed to give an edge to obtain job opportunity in clinical research field.
Our Programs are delivered in 2 Different ways for convenience of student:
• Self-Paced Individual Program (SIP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions.
• Self-Paced Blended Program (SBP)
– Skill and Job Oriented Certificate programs, delivered as Self-Paced Online with project solutions. Support thru Email and Phone for queries. Student participates in 7 days Post Training Assistance program for Resume preperation.
|Category: Clinical Research||Lessons: 26 Lessons||Duration: 08 Weeks / 200 Hours||Language: English|
Recommended: An Associate or Bachelor's degree in Medicine, Nursing, Pharmacy, Public health Biology, Biochemistry, Biotechnology, Chemistry, Clinical Research, Biomedical engineering, Public health, Pharmacology, or toxicology, Medical Device & Technology, Psychology, Sociology and Healthcare Administration.
Institutional Scholarship / Promotion is available for selected on tuition. We review your education background, certifications, and prior experiences (if applicable), to evaluate your eligibility. Qualified student will be provided with the promo code for scholarship on Tuition.
Please Email your resume to Human Resources email@example.com to check on your eligibility. We will contact you. Qtech's objective is to provide you the right career pathway and advancement required to meet your career goals.
The Benefit Student Gains
Our objective is to help Experienced Clinical Research Professionals to meet the following career pathways. Typical Clinical Research Project Management Job Titles the candidates can apply after this training program are:
|PROJECT MANAGEMENT – CLINICAL RESEARCH JOB TITLES|
|Clinical Program Manager||Manager of Office Sponsored Programs|
|Clinical Data Project Manager||Research Business Operations Analyst|
|Clinical Research Manager||Clinical Trial Project Manager|
|Manager, Integrated Clinical Trials||Clinical Study Manager|
A Clinical Research Project / Study Manager (CRM) is responsible for the monitoring, data collection and analysis, and reporting of clinical trials performed and follow Ethical practices, ICH, GCP and Clinical Safety guidelines per U.S. and international markets.
The CRPM training emphasizes on practical aspects as presentations in the reference to role performed by CRM into industry.
Our program is approachable which provides in-depth knowledge and practical exposure to roles and responsibilities performed by Clinical Research Project Manager / Study Manager. It gives insight into topics.
CLINICAL RESEARCH PROJECT MANAGEMENT AND TRIAL MONITORING
CLINICAL RESEARCH ASSOCIATE TOPICS
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 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
ADVANCED CLINCIAL RESEARCH ASSOCIATE TOPICS
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
ADDITIONAL ADVANCED CLINICAL RESEARCH TOPICS
1) Risk Based Monitoring (RBM)
2) FDA Audit process for Clinical Research
3) Clinical Trial Project Management (CTPM) 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 Modules 1 thru 4
10) Planning and Conducting Global Clinical Trials
11) Management of a Successful Clinical Research Site - Part A & B
The EXCERCISES Covered in the CRPM training program are:
1. Clinical Trial Budget
2. Investigator Selection
3. Pre-study site visit
5. Informed Consent Form
6. IND Application
7. IRB Regulatory Correspondence
8. Clinical Trial Budget
9. Investigator Selection
10. Pre-study site visit
12. CTMS Track Recording
13. Trial Master File
14. Database Lock
5.00 average based on 3 ratings
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.
The training helped me enhance my skills. The training was given in a very well planned, organized and professional manner.
The program was extremely helpful and the instructions were very knowledgeable. Thank you very much.