CRF KICKSTART
On-Demand Clinical Research Training + GCP Certification
THE SPARK OF DISCOVERY
CRF Kickstart:
On-Demand Clinical Research Training + GCP Certification
Master the Core Competencies of Clinical Research with Flexible, Self-Paced Learning. $450
Elevate Your Career:
From Coordinator
to CRA
An Intensive 3-Day CRA Training Seminar for Experienced Clinical Research Professionals. Master the transition with trusted expertise.
Get the edge you need to enter and excel in the Clinical Research industry
Are you looking to break into the high-impact world of clinical trials? Want to learn more about the clinical research industry from insiders who live and breathe it every day? Whether you’re aiming for a role as a Clinical Research Coordinator (CRC), working in Regulatory Affairs, or seeking any entry-level position at a research organization, your journey starts here.
Clinical Research Fastrack provides the foundational knowledge you need to navigate the industry with confidence—all on your own schedule. This course has been built upon the expertise of industry experts with decades of experience in this field. The curriculum includes the core principles you will need to know to ensure your success moving forward.
Who is this training for?
This self-paced program is designed for aspiring professionals looking to enter the clinical research industry. It provides the essential framework for the field, covering the fundamental rules and competencies required by Sites, CROs, and Sponsors. Gain the foundational expertise needed to launch your career and help move drug development forward.
COURSE SYLLABUS:
Estimated time to complete: 15-20 hours.
Part 1: Setting the Table
Focuses on the framework and legal landscape of clinical trials.
- The History of Clinical Research: Learn how pivotal moments in history shaped today’s GCP standards
- Participant Safety: Key principles and guidelines on ethical decision-making
- Clinical Trial Design, Phases, and Types: Dive into trial phases, study types, and how protocols are structured for success
- Key Players: Discover the roles of sponsors, sites, IRBs, and the full clinical trial ecosystem
- Investigator Responsibilities: Master oversight expectations, including the importance of the Form 1572
- FDA Regulations: Understanding the governing bodies, legal requirements, and the frameworks governing clinical research
Part 2: The Nuts & Bolts of Running a Trial
Focuses on the day-to-day operational execution of a study.
- Regulatory Affairs: Understanding and navigating the administrative and compliance requirements that keep studies aligned with regulations
- Dissecting a Protocol: Learning how to read, interpret, and execute a study plan.
- Good Documentation Practices (GDP): Mastering the principle that “if it isn’t documented, it didn’t happen.”
- Data Integrity, Governance, and Management: Ensuring study data is accurate, consistent, and reliable
- Adverse Event Reporting: Identifying, documenting, and reporting safety events appropriately
- Recruitment and Retention: Strategies to effectively enroll and engage study participants
- The Informed Consent Process: Understanding and applying one of the most critical ethical and regulatory components of clinical research
Part 3: The Pro-Guide to Performing at the Highest Level
This section is designed to elevate your performance from foundational knowledge to professional excellence. You’ll focus on how to operate effectively in real-world research environments while developing the skills and mindset needed to stand out in the field.
- Clinical Trial Operations: Understanding how studies function at the site level and the key workflows that drive execution
- Contracts and Budgets: Study Start-up. Gaining insight into the financial and administrative processes that initiate a trial
- Monitoring, Quality Assurance, and Inspections: Learning how studies are overseen to ensure compliance, quality, and readiness
- Deviations, CAPAs, and Audits: Managing issues, implementing corrective actions, and preparing for audits
- Professional Conduct: Building the communication, accountability, and professionalism expected in clinical research
- Research Skills: Strengthening critical thinking, organization, and problem-solving in a research setting
- Medical Terminology: Developing the language skills necessary to confidently navigate clinical environments
By the end of this section, you’ll not only understand how to run a clinical trial, you’ll be equipped to perform at a high level and contribute meaningfully as a clinical research professional.
Final Section: Review & ICH GCP (R3) Certification Exam
What to Expect
CRF KICKSTART ON-DEMAND TRAINING
This online, independent learning program is designed to be efficient yet comprehensive. The course is divided into three distinct modules, allowing you to learn at a pace that fits your life.
Clinical Research Fastrack’s curriculum meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. Eligible graduates in good academic and financial standing will receive a GCP (Good Clinical Practice) Certificate (valid for 3 years) upon completion of the course.