Clinical Trials Fundamentals for Life Science Graduates
Schedule
COURSE DESCRIPTION
The ‘Clinical Trials Fundamentals for Life Science Graduates’ course provides a detailed introduction to the scientific, ethical, and operational principles that underpin modern clinical research. Designed for students and young graduates in life sciences, the programme explains how clinical trials are conceived, planned, and conducted within contemporary healthcare, academic, and pharmaceutical environments. It offers a clear foundation for understanding how evidence is generated, how patient safety is protected, and how regulatory standards guide every stage of the research process.
Participants explore the historical development of clinical research and the emergence of internationally recognised standards such as ICH GCP. The course examines how clinical trials are classified, why methodological rigour is essential, and how regulatory frameworks ensure both scientific validity and ethical integrity. This grounding enables attendees to appreciate the rationale behind trial design and the safeguards that govern participant involvement.
A key component of the programme is the study of roles and responsibilities within the clinical trial environment. Attendees learn how investigators, sponsors, monitors, regulatory authorities, and other stakeholders collaborate throughout the lifecycle of a study. The course highlights how each role contributes to the quality, safety, and reliability of research outcomes, offering clarity on the multidisciplinary nature of clinical research teams.
The course also introduces participants to essential study documentation and operational processes. Through practical examples, attendees examine the structure and purpose of the study protocol, the steps involved in screening and enrolling participants, and the procedures for identifying, documenting, and managing adverse events. These insights help participants understand how theoretical principles are translated into day‑to‑day practice at research sites.
By integrating conceptual teaching with applied examples, the programme equips participants with a coherent understanding of how clinical trials function and how early‑career professionals contribute to their successful delivery. This foundation supports informed decision‑making for those considering future roles in clinical operations, monitoring, regulatory affairs, or related areas within the clinical research sector.
COURSE OBJECTIVES
Understand the foundations of clinical research: Gain clarity on how clinical trials are designed, classified, and regulated, including the historical development of the field and the principles of ICH GCP.
Recognise the roles and responsibilities within a study team: Learn how investigators, sponsors, monitors, and other stakeholders contribute to the successful delivery of a clinical trial.
Develop insight into study documentation and processes: Understand the purpose of study protocols, screening procedures, patient enrolment, and the management of adverse events.
Build practical awareness of trial operations: Explore real‑world examples and scenarios that illustrate how clinical research activities are implemented in practice.
ONLINE INSTRUCTOR-LED COURSE
Organisers: Avantyo Institute of Clinical Research
Location: Online
Date: 04th of August
Language: English
Trainer: Dr Cristina Florescu Moraid, MSc, EUSpLM, MRQA
Attendance only by online reservation. Booking available after registering on this site.
WHY ATTEND OUR CLINICAL TRIALS FUNDAMENTALS COURSE?
A solid grounding in clinical research principles: The course offers a clear and structured introduction to the scientific, ethical, and operational foundations of clinical trials, helping participants understand why rigorous methodology and regulatory compliance are essential to generating reliable evidence.
Insight into real‑world clinical trial operations: Through practical examples and case‑based explanations, attendees gain an understanding of how study protocols are implemented, how participants are screened and enrolled, and how safety events are identified, documented, and managed throughout a trial.
Understanding of roles and responsibilities within a study team: Participants learn how investigators, study coordinators, monitors, sponsors, and regulatory bodies work together, providing clarity on the collaborative nature of clinical research and the contribution of each role to study quality and integrity.
Preparation for early‑career opportunities: The course helps students and graduates recognise the types of entry‑level positions available within clinical research, the skills required for these roles, and how foundational knowledge of trial processes supports professional development.
Guidance from an experienced clinical research professional: Led by Dr Cristina Florescu Moraid, the programme benefits from expert insight into the realities of clinical trial conduct, offering participants a balanced understanding of both theoretical principles and practical challenges.
A strong starting point for further training: By establishing a clear conceptual framework, the course prepares participants for more advanced study in clinical operations, monitoring, regulatory affairs, data management, or related areas within the clinical research sector.
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 research.
PARTICIPANT PROFILE
This course is intended for students and young graduates in the life sciences who require a clear and structured introduction to the field of clinical research. It is particularly suitable for individuals who wish to understand how clinical trials are designed, regulated, and conducted, and who are exploring how their scientific background can be applied within the pharmaceutical, biotechnology, or healthcare sectors.
Participants typically include:
– Students and recent graduates in medicine, pharmacy, biology, chemistry, physics, biophysics, biotechnology, or related disciplines who want to gain an initial understanding of clinical trial methodology and operations.
– Individuals considering alternative career pathways beyond clinical practice or laboratory‑based research and who wish to understand the professional landscape of clinical research.
– Early‑career professionals seeking clarity on the responsibilities of study teams, the structure of trial documentation, and the operational processes that support participant safety and data integrity.
– Those preparing for entry‑level roles such as clinical trial assistant, study coordinator, regulatory support specialist, or junior positions within clinical operations and monitoring.
The course is designed for participants who may have limited prior exposure to clinical research but who are motivated to build a solid conceptual foundation before progressing to more specialised training or applying for industry roles. It provides the context, terminology, and practical understanding necessary to navigate the early stages of a career in clinical research with confidence.
Cristina Florescu Moraid President of Clinical Trials Symposium, CEO Avantyo Institute of Clinical Research
Dr Florescu Moraid earned her Medical Doctor degree in 1998 from the Carol Davila University of Medicine and Pharmacy in Bucharest. She was accredited as a Laboratory Medicine Specialist in 2005 and as a Senior Laboratory Medicine Specialist in 2011 by the Romanian College of Physicians.
She completed a Master of Science degree in 2006, the Postgraduate School of Clinical Trials Management in Gdańsk in 2012, and the Postgraduate Leadership Development Programme at the University of Sussex in 2014.
Between 2005 and 2018, Dr Florescu Moraid led clinical trial operations at Synevo Central Lab, the clinical research division of the Swedish Medicover Group, serving as Regional Director for Romania, Moldova, Bulgaria, and Serbia. During this period, she also organised the Synevo Clinical Trials Symposium for ten consecutive years.
Since 2019, she has been the Co-founder of Avantyo - Institute of Clinical Research and the CEO of Camina Medical Experts, providing tailored clinical trial services to pharmaceutical sponsors, CROs, and mid-sized biotech companies.
She is a frequent invited speaker at scientific meetings and a committed advocate for strengthening awareness of the value of clinical trials for patients.
For previous events, please access one of the following links.
