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Study Coordinator
Study Coordinator
Curriculum
6 Sections
23 Lessons
10 Weeks
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Module 1: Overview of Clinical Trial Management
5
1.1
Chapter 1: Key Stakeholders and Their Roles – Understand the crucial impact of each stakeholder’s role from initiation to execution.
1.2
Chapter 2: Regulatory Frameworks and Ethics – Navigate through complex regulations and ethical dilemmas, learning how to safeguard participant rights and trial integrity.
1.3
Chapter 3: Introduction to Clinical Trial Teams – Delve into team dynamics and the synergy between investigators, coordinators, and nurses.
1.4
Chapter 4: Vendor Management in Clinical Trials – Become adept at selecting and managing the array of vendors who make clinical trials possible.
1.6
🎦
Module 2: Planning and Setup of Clinical Trials
5
2.0
Chapter 1: Site and Trial Preparation – Equip yourself with the skills to set up trial sites that meet all logistical and regulatory requirements.
2.1
Chapter 2: Good Clinical Practice (GCP) – Immerse in the golden standards of clinical practice that ensure safety and efficacy in trials.
2.2
Chapter 3: Document Compliance and Management – Learn the art of maintaining critical documents like the Trial Master File (TMF) and essential logs.
2.3
Chapter 4: CRF Design and Documentation – Get hands-on with creating Case Report Forms that capture comprehensive and accurate trial data.
2.4
🎦
Module 3: Execution of Clinical Trials
5
3.0
Chapter 1: Recruitment and Participant Management – Master the techniques of effective participant recruitment and engagement to minimize dropout rates.
3.1
Chapter 2: Data Management and Integrity – Harness high-tech tools like IWRS for flawless data management and integrity.
3.2
Chapter 3: Operational Crisis Management – Develop critical skills to manage and mitigate crises, ensuring trials run smoothly against all odds.
3.3
Chapter 4: The Role and Responsibilities of a Study Coordinator in Clinical Trials – Uncover the multi-faceted role of a Study Coordinator in the heart of trial operations.
3.4
🎦
Module 4: Closing Trials and Professional Development
5
4.0
Chapter 1: Effective Trial Closure – Learn to wrap up trials meticulously, ensuring all aspects are compliant and audit-ready.
4.1
Chapter 2: Data Analysis and Reporting – Turn raw data into powerful insights through sophisticated analysis and reporting techniques.
4.2
Chapter 3: Continuous Education and Career Development – Stay ahead in the field with continuous learning opportunities and professional networking.
4.3
Chapter 4: Advanced Career Development – Step up your career ladder, gaining expertise to navigate complex projects and lead trial strategies.
4.4
🎦
Quiz
1
5.1
Study Coordinator: Quiz
12 Questions
Premium Materials Included in Your Course Package:
3
6.1
What is IWRS
6.2
Documentation in Clinical Trials and ALCO+
6.3
eCRF
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