How to become an investigator
A clinical trial investigator is a medical expert responsible for finding eligible patients to be included in a clinical trial and organizing the study team that works at the site with the patient during the entire clinical trial.
Participation in clinical trials empowers physicians to deepen their understanding of their specific area of expertise, acquaint themselves with innovative medical treatments, and offer additional choices or alternative therapies to their patients.
The course will cover crucial topics essential for conducting clinical research and is tailor-made for doctors, clinicians or general practitioners serving as Principal investigator or Sub - Investigator within a clinical study.
Topics covered by the course:
- Drug Development and appearance of GCP
- Responsibilities split as per ICH-GCP (investigators vs sponsor)
- Essential documents in Clinical Trials
- Medical records and other medical records in clinical trials
- Informed consent form – investigators’ approach
- Selection of patients – methods, including advertisement
- Safety reporting
- Audits and inspections
Training Courses Details:
Dates / Time:
- Thursday October 12 | 13:00 – 18:00 Bucharest time (GMT+2)
- Friday October 13 | 13:00 – 18:00 Bucharest time (GMT+2)
Registration: online; Deadline: October 10th, 2023.
In the dynamic and ever-evolving field of medical research, the leadership role of the Principal Investigator as well as Sub - Investigator create the foundation of a successful clinical trial. This course is designed for physicians, whether they are recent graduates or experienced professionals, who are eager to work in clinical research and contribute to the advancement of science for the benefit of patients.
A clinical trial investigator is a medical expert responsible for finding eligible patients to be included in a clinical trial and organizing the study team that works at the site with the patient during the entire clinical trial.
Responsibilities of a clinical trial Principal investigator and Sub - Investigator:
- Educating trial participants about the trial procedures
- Conducting ethical research on potential new medical TREATMENTS
- Ensuring respectful treatment of each patient and safeguarding their privacy and rights
- Administering medications or utilizing medical devices to evaluate their efficacy
- Documenting and reporting their observations and findings throughout the trials
- Staying up-to-date with regulations and prerequisites concerning clinical trials
- Exploring avenues to enhance knowledge within their specialized field
Dr. Catalina SARBU Secretary General of the Romanian Association of CROs (ACCSCR) Romania
- 2004-2022 GMBA and Director Clinical Operations - PAREXEL International Romania S.R.L.
- 2000-2022 Director of the Romanian Representative office of PAREXEL Nederland BV
- Former President of the CRO Association in Romania (ASSCRC)
- General Practitioner – Center of Hematology, Ploiesti, Romania
- Saint Antoine University, Paris, France - Hematology and Blood Transfusion, 1-year courses
- University of Medicine and Pharmacy, Bucharest, Romania -Medical Doctor Degree
Conf. Dr. George Daniel Radavoi Head Physician of Urology Section II, Prof. Dr. Th. Burghele Clinical Hospital. , Bucharest | University Lecturer, UMF Carol Davila, Bucharest
- 2022–Present: University Lecturer, UMF Carol Davila, Bucharest
- 2018: Head Physician of Urology Section II, Prof. Dr. Th. Burghele Clinical Hospital. , Bucharest
- 2018–2022: Head of Works, UMF Carol Davila, Bucharest
- 2014–Present: Urologist Primary Physician, Prof. Dr. Th. Burghele Clinical Hospital, Bucharest
- 2020–2021: Scientific Researcher III, UMF Carol Davila Bucharest - Project "Discovering the causes of cancer through mutational changes", Bucharest
- 2017 – 2018: University Assistant for an indefinite period, UMF Carol Davila, Bucharest
- 2012 – 2016: University Assistant for a fixed period, UMF Carol Davila, Bucharest
- 2012 – Present: Sub-investigator in over 15 studies on the treatment, safety and efficacy of treatment administration in various urological, cancerous and non-cancerous pathologies
- 2012 – 2014: Specialist Urologist, Prof. Dr. Th. Burghele Clinical Hospital, Bucharest
- 2011 – 2016: PhD student, by competition, full-time, with a scholarship, in the specialty of Urology, UMF Carol Davila, Bucharest
- 2011 – 2013: Urologist, Private Clinic, Bucharest
- 2009 – 2012: Urologist, CMI "Dr. Dragomiristeanu Ion", Bucharest
- 2004 – 2008: Resident Urologist, Prof. Dr. Th. Burghele Clinical Hospital, Bucharest
Dr. Cristina Florescu Moraid President of Clinical Trials Symposium, CEO AVANTYO Institute of Clinical Research
- Dr. Florescu Moraid got her Medical Doctor Diploma in 1998 from „Carol Davila” University of Medicine and Pharmacy in Bucharest, Romania and was accredited as Laboratory Medicine Specialist in 2005 and as Senior Laboratory Medicine Specialist in 2011, by the Romanian College of Physicians.
- She got her Master of Science Diploma in 2006 , accomplished Postgraduated School of Clinical Trials Management, Gdansk in 2012 and the Postgraduated Leadership Development Programme at University of Sussex, UK in 2014.
- Dr. Florescu Moraid was responsible for clinical trials operations at Synevo Central Lab, the clinical research wing of Swedish Medicover Group as Regional Director for Romania, Moldova, Bulgaria and Serbia between 2005-2018. She has been organizing Synevo Clinical Trials Symposium for 10 years.
- Since beginning of 2019, she is Co-founder of Avantyo - Institute of Clinical Research and CEO of Camina Medical Experts, developing tailored CT services for pharma sponsors, CROs and mid-size biotech companies.
- She is invited speaker for different scientific events and acts as active advocate for rising awareness over the importance of developing clinical trials for the patient’s benefit.
Assoc. Prof. Dr. Michael Schenker President of The Oncology Commision Ministry of Health and The founder and head of “Saint Nectarie” Oncology Center, Romania
- President of The Oncology Commision Ministry of Health and The founder and head of “Saint Nectarie” Oncology Center, Romania
- Assoc. Prof. Dr Michael Schenker, a chief oncologist in Craiova, is one of the few Romanian specialists who have managed to conduct clinical trials of the FDA (Food and Drug Administration, USA) for biological substances against cancer.
- Dr Schenker is associated professor at the University of Medicine and Pharmacy from Craiova, and the founder and head of “Saint Nectarie” Oncology Center (Craiova), since 2014.
Dr. George Regio Tanaseanu President of the Romanian Association of CRO’s (ACCSCR) Country Manager PSI CRO AG Romania
- Dr. Tanaseanu is the present PSI CRO AG Country Manager for Romania since 2015, being responsible for planning and implementing country / region strategy, resource allocation; performance appraisal
- staff training
- budget management
- supervision and optimization of corporate and operations activities
- quality assurance and quality control
- communication with clients, vendors, project teams on project and administrative matters
- development of country-specific guidelines
- participation in feasibility evaluation and in client and bid-defence meetings for Romania, Moldova plus France, Italy and Spain.
- clinical research senior professional with 20+ years of experience in the industry
- 2022 Head of the CRO Association in Romania (ACCSCR)
For previous events, please access one of the following links.
