Clinical Trials for Study Coordinators
Schedule
Payment by credit card or bank transfer
BOOK & PAY DEADLINE: March 12, 2025
Early bird discount 15% for those who register by 28th of February 2025 No VAT refund. Corporate discounts: 5% for over 3 participants 10% for over 5 participants For more information please contact us at info@avantyo.com or 0726 840 456
COURSE DESCRIPTION
This comprehensive course is designed to equip study coordinators with the essential knowledge and skills needed to effectively manage and conduct clinical trials. Participants will gain a thorough understanding of the clinical trial process, including project management, research design, protocol development, and regulatory compliance.
Through a combination of lectures, practical exercises, and interactive discussions, participants will be well-prepared to contribute effectively to clinical trials. This holistic approach ensures not only the acquisition of theoretical knowledge but also the development of practical skills essential for real-world application. Participants will be able to navigate the complexities of clinical trials, manage various aspects of the study efficiently, and ensure strict adherence to protocols and regulatory standards. By the end of the course, participants will have the confidence and competence to play a pivotal role in advancing clinical research and contributing to the success of clinical trials.
Key topics covered include:
- Phases and Designs of Clinical Research: Understand the different phases and designs involved in clinical research.
- Roles and Responsibilities of Investigational Site Staff: Learn about the roles and duties of various staff members at investigational sites.
- Facilitating mutual acceptance of clinical trial results: Harmonising standards across different regions to support global collaboration in drug development.
- Promoting transparency and accountability: Encouraging the registration of clinical trials and the reporting of results to maintain public trust.
- Development and Management of Study Protocols and Informed Consent Forms: Gain expertise in creating and managing study protocols and informed consent forms.
- Safety Reporting: Learn about adverse events, serious adverse events, and other safety reporting requirements.
- Role of the Study Coordinator: Understand the responsibilities of a study coordinator in study start-up, recruitment, and site visits.
- Management of Investigational Medicinal Products and Medical Devices: Learn how to manage investigational medicinal products and medical devices.
ONLINE INSTRUCTOR-LED COURSE
Organizers: Avantyo Institute of Clinical Research
Location: Online
Duration: 2-day sessions for 4 hours each day
Training days: March 13-14, 2025
Training time: From 2 PM GMT+2
Language: English
Trainer: Dr. Goran Vesov, MD
Attendance only by online reservation. Booking available after registering on this site.
WHY ATTEND OUR CLINICAL TRIALS FOR STUDY COORDINATORS COURSE?
Comprehensive Understanding of Clinical Trials: Gain the ability to prepare sites for clinical trial start-up with an in-depth understanding of the entire clinical trial process, from project management to research design and protocol development.
Expert Trainers: Learn from experienced professionals like Dr. Goran Vesov, who bring real-world insights and expertise to the training.
Effective Clinical Trial Conduct: earn to conduct clinical trials proficiently by mastering patient recruitment and retention strategies, data management, data monitoring, pharmacovigilance, safety reporting, and good financial practices.
Quality Systems and Compliance: Acquire the skills to design and maintain the quality system of a clinical trial by implementing Standard Operating Procedures (SOPs), handling audits and inspections, and ensuring other aspects of Quality Assurance (QA) and Quality Control (QC).
Research Site Management: Identify and address key challenges in managing research sites, including developing and maintaining site capacity, engaging with the community, and managing grants efficiently.
People Management and Collaboration: Develop essential people management skills and techniques that will enhance your ability to work effectively with internal colleagues and external partners. This offer provides an excellent opportunity for those eager to continue their professional development in the field of clinical research.
For discounts and assistance, or if you wish to be placed on a waiting list for the next course, or require any additional information, please contact us at diana.lupu@avantyo.com (+40 0726 840 456). Be sure to mention your specific educational requirements in clinical trials.
A Clinical Research Coordinator (CRC) plays a crucial role in managing clinical research according to the protocol, International Council for Harmonisation (ICH) - Good Clinical Practice (GCP), and other regulatory requirements. The responsibilities of a CRC are diverse and encompass various aspects of clinical trial management, including but not limited to:
- Questionnaire Administration: Administering questionnaires to participants to gather relevant data for the study.
- Participant Information: Informing participants about the objectives, procedures, and expected outcomes of the study.
- Data Collection: Collecting, recording, and maintaining accurate data from participants throughout the trial.
- Recruitment: Actively participating in the recruitment and screening of subjects to ensure they meet the inclusion and exclusion criteria for the study.
- Trial Management: Overseeing the day-to-day activities of clinical trials, ensuring they adhere to the established protocols and regulatory standards.
Additionally, Clinical Research Coordinators have the critical task of explaining to subjects what to expect during the trial and addressing any concerns they may have. This interaction necessitates strong communication and interpersonal skills, as CRCs must build trust and ensure participants feel informed and comfortable throughout the trial process.
Key Skills and Competencies:
- Effective Communication: The ability to clearly and effectively communicate information to participants, study teams, and other stakeholders.
- Interpersonal Skills: Building rapport and maintaining positive relationships with participants and colleagues.
- Organizational Skills: Managing multiple tasks and maintaining detailed records to ensure trial adherence and accuracy.
- Ethical Awareness: Understanding and upholding ethical standards in clinical research, ensuring participant safety and confidentiality.
- Problem-Solving: Addressing issues that arise during the trial and finding effective solutions to ensure smooth trial progress.
Qualifications and Experience:
- Educational Background: A degree in a relevant field such as life sciences, nursing, pharmacy, or a related discipline.
- Experience: Previous experience in clinical research or a related field is highly desirable.
- Certification: Certification in Good Clinical Practice (GCP) and familiarity with ICH guidelines are essential.
By fulfilling these roles and responsibilities, Clinical Research Coordinators play a vital part in the success of clinical trials, contributing to the advancement of medical knowledge and the development of new treatments. Their dedication ensures that clinical research is conducted ethically, accurately, and efficiently, ultimately benefiting patient care and medical progress.
Dr. Goran Vesov, MD Crest Consulting LLC, North Macedonia
Dr. Goran Vesov, MD is a drug development professional with 20+ years of international experience - in big pharma, multinational CRO and as freelancer. He is currently owning and managing CResT Consulting, a clinical research quality and training consultancy, providing services to pharmaceutical companies and CROs alike.
His expertise encompasses:
- Thorough knowledge of ICH GCP and its current developments
- Experience in onboarding and advanced training of Clinical Research professionals (Sponsor, CRO and Site staff)
- Proficiency in development and implementation/follow-up of GCP Inspection readiness programs
- GCP Auditing of Clinical Investigational Sites
- Profound understanding and experience in Quality Assurance (e.g., development and update of Quality Management Systems)
- Clinical Research process improvement
- Medical Doctor degree, specialized in paediatrics and Master of science degree in paediatric endocrinology and genetics.
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