Course Description
This 2-day dynamic professional development program is designed to enhance the knowledge, practical skills, and career readiness of professionals involved in clinical trials—including, but not limited to, Clinical Research Coordinators (CRCs), Clinical Research Associates (CRAs), and individuals in biotech, pharmaceutical, and Contract Research Organization (CRO) roles.
Whether you're new to clinical research or looking to expand your impact, this course offers a thorough understanding of the clinical trial lifecycle, Good Clinical Practice (GCP), regulatory frameworks, and core competencies essential for success in today’s complex research landscape.
Program Highlights:
- Foundational and Advanced Training in trial start-up, site management, monitoring activities, documentation, patient recruitment strategies, and stakeholder communication.
- Real-World Application through case studies, interactive sessions, and practical tools tailored to daily operational challenges.
- Exclusive Guest Speaker Series featuring seasoned industry professionals and thought leaders who will share career insights, best practices, and emerging trends in clinical research.
- Career Development Focus designed to help participants navigate growth opportunities and expand their professional network across biotech, pharma, and CRO sectors.
By the end of this program, you will be equipped with the critical skills and confidence needed to drive clinical trial excellence and advance your career in a rapidly evolving field.
Course Summary
Upcoming Courses
Learning Objectives
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Introduction to Clinical Research
- Identify the key stakeholders involved in clinical trials (sponsors, CROs, sites, regulators).
- Differentiate between CRC and CRA roles, responsibilities, and career paths.
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Good Clinical Practice (GCP) and Ethics
- Explain the principles of ICH-GCP and their application to clinical research.
- Apply ethical considerations to informed consent and subject protection.
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Regulatory Environment
- Recognize the role of regulatory bodies (Health Canada, FDA, EMA) in clinical research.
- Describe the process of clinical trial submissions and approvals (IND, CTA).
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Study Start-Up and Site Initiation
- Outline the feasibility and site selection process for clinical trials.
- Prepare essential regulatory documents for site initiation visits.
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Participant Recruitment & Retention
- Develop effective recruitment strategies tailored to specific study populations.
- Apply retention strategies to minimize participant dropout and maximize trial success.
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Conducting Clinical Trials (Day-to-Day Operations)
- Demonstrate best practices for source documentation and case report forms (CRFs).
- Manage safety reporting and adverse event documentation effectively.
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Monitoring & Data Integrity
- Explain the differences between on-site and remote monitoring practices.
- Apply methods for ensuring source data verification and query resolution.
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Documentation, Audits, and Inspections
- Organize and maintain essential records in the Investigator Site File (ISF).
- Prepare for sponsor audits and regulatory inspections with confidence.
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Professional Skills & Stakeholder Management
- Demonstrate effective communication strategies with sponsors, CROs, and site staff.
- Apply conflict resolution and time management techniques in clinical research settings.
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Guest Speaker Panel & Networking Session
- Gain real-world insights from experienced CRCs, CRAs, and industry leaders.
- Build networking skills to support professional growth and career advancement.
Who Should Attend
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Early-career CRCs and CRAs — individuals interested in working in the field of clinical research or those currently working in research who want structured professional development and practical skill-building.
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Healthcare and research staff — nurses, laboratory staff, research assistants, or administrative professionals seeking to transition into CRC/CRA roles.
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Internationally trained professionals — individuals with medical, pharmacy, or research backgrounds aiming to enter the North American clinical research industry.
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Professionals exploring career progression — those considering advancement into senior CRC/CRA positions, project management, or other leadership roles in clinical research.
Course Outline
Day 1 – Foundations and Core Competencies
Module 1: Introduction to Clinical Research Roles
- Key responsibilities of CRCs vs. CRAs
- Collaborations across study teams and stakeholders
- Career progression and development opportunities
Module 2: Good Clinical Practice (GCP) & Regulatory Foundations
- ICH-GCP guidelines and ethical principles
- Informed consent process and protection of human subjects
- Role of IRBs/ethics committees and regulatory submissions
Module 3: Study Start-Up and Site Initiation
- Site feasibility, selection, and start-up activities
- Essential documents and Investigator Site Files (ISF)
- Site initiation visits and staff training
Day 2 – Advanced Operations and Professional Development
Module 4: Conducting and Monitoring Clinical Trials
- Subject recruitment and retention strategies
- Source data verification, data quality, and query management
- Safety reporting and adverse event documentation
- On-site vs. remote monitoring practices
Module 5: Documentation and Data Integrity
- Essential records and regulatory binder maintenance
- Electronic Data Capture (EDC) systems
- Preparing for audits and inspections
Module 6: Communication and Stakeholder Management
- Effective site-sponsor-CRO communication
- Conflict resolution and escalation pathways
- Building strong site relationships
Module 7: Guest Speaker & Networking Panel
- Insights from experienced CRCs, CRAs, and clinical research leaders
- Discussion on challenges, best practices, and career advice
- Open Q&A and networking opportunity
Interactive Activities
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Case study on preparing a site for initiation
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Insights from experienced CRCs, CRAs, and clinical research leaders
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Discussion on challenges, best practices, and career advice
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Open Q&A and networking opportunity
