TRAINING

The changing world of clinical research requires strong and comprehensive training for professionals in the field. As clinical trials become more complex and tightly regulated, it is crucial for these professionals to have a solid understanding of research methods, ethical issues, and data management. Additional training in areas like phlebotomy and medical assistance enhances their skills, allowing them to handle important tasks such as collecting samples and caring for patients effectively and accurately. This kind of integrated training not only improves the quality of research results but also ensures the safety and well-being of participants, which is essential for advancing medical science. By investing in specialized training, we equip professionals with the tools they need to face challenges, encourage innovation, and uphold the integrity of clinical trials.

Hybrid Training: Our training program for clinical research professionals is a hybrid model that blends in-person and online learning to offer the best of both worlds. This flexible approach allows participants to enjoy interactive classroom sessions where they can connect directly with instructors and fellow students, while also taking advantage of self-paced online modules that provide easy access to all course materials. By combining hands-on experiences with digital learning, we create a dynamic environment that supports various learning styles and fits different schedules. This hybrid system not only helps improve knowledge retention but also ensures that professionals can put their skills into practice in real-world situations, preparing them to succeed in the ever-changing field of clinical research.

Clinical Research Coordinator Training:
- Certifications: Phlebotomy/EKG
Principle Investigator Training
Clinical Research Associate Training

Our Training Courses

What is Clinical Research?

Training Program & Requirements

Costs & Payment Options

Training FAQs

Clinical Research Coordinator Training

Principle Investigator Training

Clinical Research Associate Training

Clinical Research Principal Investigator Training Course

Requirements

Medical Doctor
Other Doctorate

This training course is designed for Principal Investigators (PIs) in clinical research, focusing on Good Clinical Practices (GCP) and the PI’s critical role in managing clinical trials. The course emphasizes ethical considerations, regulatory compliance, and effective oversight of clinical research activities.

Course Objectives:

Good Clinical Practices (GCP): Understand the principles and guidelines of GCP and articulate their importance in clinical research, including ethical considerations and the importance of participant welfare.
Principal Investigator Responsibilities: Understand the roles, authority, and obligations of the Principal Investigator, including oversight of study staff and maintaining study documentation.
FDA Regulations: Familiarity with FDA regulations related to clinical trials, particularly the Code of Federal Regulations (CFR) Title 21, Part 312 (Investigational New Drug Application).
ICH Guidelines: Knowledge of International Council for Harmonization (ICH) guidelines, particularly E6(R2), which outline GCP.
Regulatory and Ethical Compliance: Navigate regulatory requirements and ethical considerations in clinical trials, ensuring respect for participant autonomy, beneficence, and justice.
Study Protocol Management: Effectively manage study protocols, understanding the necessity of protocol adherence and managing any amendments appropriately to ensure participant safety and data integrity.
Study Design: Learn to design effective and robust clinical trials and develop clear protocols to facilitate research objectives.
Data Management: Master data collection, management, and quality assurance techniques to ensure the accuracy, consistency, and reliability of data collected during clinical trials.
Adverse Events Monitoring: Understand the definitions, processes, and responsibilities associated with monitoring adverse events and ensuring participant safety.
Risk Management: Develop skills in identifying, assessing, and mitigating risks throughout the clinical trial process.
Challenges in Trial Management: Address common challenges in clinical trial management to ensure compliance and uphold the integrity of the research.
Participant Recruitment and Retention: Implement strategies for effective participant recruitment and retention while adhering to ethical standards.
Monitoring and Quality Assurance: Understand the importance of monitoring trial progress, data quality, and compliance with GCP and regulatory standards.
Collaborative Practices: Foster collaboration with study sponsors, ethics committees, and regulatory bodies to ensure compliance and effective communication.

Certification:

Participants who successfully complete the course will receive a certificate of completion as well as industry standard certification, attesting to their knowledge and understanding of Good Clinical Practices in clinical research.

Clinical Research Associate (CRA) Training Course

Requirements

Life Sciences Professionals
Nurses
Biotech Professionals
Medical Sciences Professionals

This training course is designed for Clinical Research Associates (CRAs), providing them with a comprehensive understanding of Good Clinical Practices (GCP) and their vital role in the management of clinical trials. The course will emphasize regulatory compliance, ethical considerations, monitoring responsibilities, and best practices for ensuring data integrity and participant safety.

Course Objectives:

Understanding Good Clinical Practices (GCP): Explain the principles and significance of GCP for ethical and scientific integrity in research.
Familiarity with FDA Regulations: Know relevant FDA regulations (21 CFR Parts 312 and 812) and their application to investigational products.
Knowledge of ICH Guidelines: Understand and apply ICH guidelines, particularly E6(R2), for compliance in clinical trials.
Roles and Responsibilities of Clinical Research Associates: Describe the specific duties and functions of a Clinical Research Associate in trial management.
Study Protocol Adherence: Ensure strict adherence to approved study protocols and manage amendments accordingly.
Site Management: Develop skills in monitoring study sites for regulatory compliance and ethical standards.
Monitoring Responsibilities: Conduct effective monitoring of clinical trials to ensure data quality and participant protection
Data Collection and Management: Master techniques for accurate data collection, management, and quality assurance.
Safety and Adverse Event Reporting: Understand processes for identifying, documenting, and reporting adverse events promptly.
Participant Welfare: Prioritize participant safety, informed consent, and ethical treatment throughout the study
Collaboration Skills: Build effective communication with sponsors, investigators, and regulatory bodies.
Identify and Resolve Challenges: Recognize common challenges encountered during clinical trial monitoring and develop strategies to overcome them.

Certification:

Clinical Research Coordinator Training Course

Requirements

Non-Degree Healthcare Professionals
Nurses
Nurse Assistants
High School Diploma - GED

This training course is designed to provide Clinical Research Coordinators (CRCs) with a comprehensive understanding of Good Clinical Practices (GCP) and their application in clinical research. The course will cover essential principles, regulatory requirements, and practical skills necessary for effective clinical trial management.

Course Objectives:

Understand the key principles of Good Clinical Practices (GCP) as a set of internationally recognized ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials
Recognize the roles and responsibilities of a Clinical Research Coordinator (CRC) in clinical trials, including site management, participant recruitment, and adherence to study protocols
Ensure compliance with regulatory requirements and ethical standards, identifying key FDA regulations such as 21 CFR Parts 312 and 812, and understanding the significance of ICH guidelines like E6(R2)
Manage study protocols effectively, understanding their importance as detailed plans outlining objectives, design, methodology, and statistical considerations
Maintain accurate study documentation and data integrity, emphasizing the role of accurate data collection, documentation practices, and electronic data capture systems
Describe the informed consent process, ensuring participants are fully informed and voluntarily agree to participate in trials
Explain strategies for effective participant recruitment and retention, considering ethical and compliance aspects
Define processes for monitoring participant safety and reporting adverse events, including serious adverse events (SAEs) to appropriate regulatory bodies
Recognize the importance of quality assurance processes and audits in maintaining compliance with GCP, FDA regulations, and ICH guidelines
Highlight the need for effective collaboration and communication with sponsors, investigators, and regulatory agencies to ensure smooth trial operations
Understand ethical considerations in clinical research, including the principles of respect for persons, beneficence, and justice as outlined in the Belmont Report
Emphasize the importance of quality assurance and continuous improvement in clinical research practices

Certification:

CRC

CRA

Training Registration

Training

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