This program is approved by New Jersey Department of Education (DOE) and Department of Labor and Workforce Development (DOL). Funding Option is available to qualified NJ Resident students, contact us to check on requirements.
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 protocol development, assessment and reporting of adverse events and explain GCP-ICH guidelines along with other necessary regulatory information. The course emphasizes on the 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 the 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 opportunities in the clinical research field.
Our Programs are delivered in 2 Different ways for convenience of student:
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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.
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Admission Requirements:
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.
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Institutional Scholarship / Promotion:
Institutional Scholarship / Promotion is available for selected on tuition. We review your educational background, certifications, and prior experiences (if applicable), to evaluate your eligibility. The qualified student will be provided with the promo code for scholarship on Tuition.
Please Email your resume to Human Resources qpdc@qtech-solutions.us 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.
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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
LISTED AS PRIVATE SCHOOL (USA)
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Career Pathways
Our objective is to help students to meet the following career pathways. Typical Clinical Research Associate (CRA) Job Titles the candidates can apply after this training program are:
- Clinical Research Associate
- Clinical Research Coordinator
- RN Clinical Research Coordinator
- Clinical Research Training Coordinator II
- Research RN Coordinator
- Regulatory Coordinator
- Research Nurse
- Research Associate
- Research Registered Nurse
- Admin Assistant
- Clinical Research Nurse II
- Clinical Research Administration & Operations
- TMF Specialist
- Documentation Specialist
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 Research Associate/ Clinical Research 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.
| CLINICAL RESEARCH ASSOCIATE / COORDINATOR | |
| LIST OF 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 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 EXCERCISES 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 |
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