Сергій

CURRICULUM VITAE
Serhii Shestopal
Address: 3 Rue Jean Giono, 06800, Cagnes-sur-Mer, France
Phone: [open contact info](look above in the "contact info" section)
WhatsUp/Telegram/Viber: [open contact info](look above in the "contact info" section)
E-mail: [open contact info](look above in the "contact info" section)

Summary
Over 15 years of clinical research experience in CRO environment. I have worked in
different roles, from CRA to Senior CRA2 across a variety of therapeutic areas in
Ukraine, Russia, Belarus and Georgia.

Professional, ethical, self-motivated, independent worker, quick to learn new systems
and processes, remains calm under pressure.

Seeking full-time or part-time positions in the clinical research arena. Ready for
business trips and relocation.

• Medical Doctor with surgery experience.
• Knowledge of clinical trial conduct.
• Skills in applying clinical research regulatory requirements i.e. ICH GCP and
relevant local laws, regulations and guidelines, towards clinical trial conduct.
• Strong written and verbal communication skills in English, Russian, Ukrainian
languages.
• Strong presentation skills.
• Strong problem solving skills.
• Planning, time management and prioritization skills.
• Ability to handle conflicting priorities.
• Attention to detail and accuracy in work.
• Results-oriented approach to work towards delivery and output.
• Demonstrated learning agility and openness to learning and keeping own
knowledge and skill set current and evolving.
• Good software and computer skills, including MS Office applications
• Advanced Mac user.
• Ability to establish and maintain effective working relationships with coworkers
and managers.
• Strong CTMS and Data Capture Systems user.
Employment Roles & Responsibilities
History
CromosPharma Senior CRA2
Jul 2020 - Monitoring responsibilities for 2 oncology studies (lung and breast
Mar 2024 cancer) involving 10 leading sites in Ukraine; psoriasis and
ulcerative colitis studies in Ukraine (site selection, initiation, site
management, monitoring, IP management and close out).

Biorasi Senior CRA, Regulatory Manager
Oct 2017- Monitoring and regulatory responsibilities for 1 oncology study
Jul 2020 (breast cancer) involving 4 leading sites in Ukraine; external
anogenital warts study and chronic motor deficit after traumatic
brain injury study in Ukraine (site selection, initial submission
package collection, preparation, RA submissions and notifications,
IP import, site initiation, site management, monitoring, IP
management and close out for Ukrainian sites).

PPD Senior CRA
Oct 2016 – Monitoring responsibilities for ulcerative colitis and Crohn disease
Oct 2017 studies in Ukraine (site selection, initiation, site management,
monitoring, IP management and close out).

Accelsiors Senior CRA
Feb 2014 – Monitoring responsibilities for 2 growth hormone deficit studies in
Oct2016 Russia, Belarus and Ukraine (site selection, initiation, site
management, monitoring, IP management and close out).

Parexel Clinical Enrollment Manager
Jan 2013 - Enrollment management responsibilities for global pulmonology
Feb 2014 study (COPD) involving 14 sites in Ukraine.

Eastern Clinical Senior CRA, Regulatory Manager
Trials Monitoring and regulatory responsibilities for COPD and diabetes
Jan 2011 - mellitus II studies in Ukraine (site selection, initial submission
Jan 2013 package collection, preparation, RA submissions and notifications,
IP import, site initiation, site management, monitoring, IP
management and close out for Ukrainian sites).

WCT Clinical Research Associate
Oct 2008 - Monitoring responsibilities for 2 diabetes mellitus II studies in
Jan 2011 Ukraine (initiation, site management, monitoring, IP management
and close out for Ukrainian sites).
Kyiv Psychiatric Surgery Department Head
Hospital #1 Surgery care for psychiatric patients of the clinic.
Sep05 – Oct 08

UA Center of GeneralEndocrine, Vascular and Endovascular Surgeon
Endocrine General surgery, endocrine and vascular diseases treatment.
Surgery
Aug2002 –
Oct 2008
Education
2018 National Master of Law
Academy of
Management
2002 Vinnitsa Medical Doctor
State
Medical
University

Study & Therapeutic Experience

Ulcerative colitis 2 protocols , III (8 sites) Ukraine Site selection, initiation,
site management,
monitoring and close-out

Breast Cancer 2 protocols , III (9 sites) Ukraine Site selection, initiation,
site management,
monitoring and close-out,
regulatory management.

Lung Cancer III (7 Sites) Ukraine Site selection, initiation,
site management,
monitoring and close-out

External Anogenital Warts III (5 sites) Ukraine Site selection, initiation,
site management,
monitoring and close-out

Psoriasis III (4 sites) Ukraine Site selection, initiation,
site management,
monitoring and close-out

Stem cells brain II (1 site) Ukraine Site initiation, site
implantation after brain management, monitoring
injury and close-out

Diabetes mellitus II 2 protocols, III (13 sites) Ukraine Site initiation, site
management, monitoring
and close-out

Growth hormone deficit 2 protocols, III (15 sites) Russia, Belarus, Ukraine Site selection, initiation,
site management,
monitoring and close-out

Ulcerative colitis 2 protocols, III (13 sites) Ukraine Site selection, initiation,
site management,
monitoring and close-out

Crohn disease III (7 sites) Ukraine Site selection, initiation,
site management,
monitoring and close-out

Chronic Obstructive 2 protocols , III (22 sites) Ukraine Site selection, initiation,
Pulmonary Disease site management,
monitoring and close-out

Chronic Obstructive III (14 sites) Ukraine Enrollment management,
Pulmonary Disease periodic onsite motivation
visits and phone calls to
sites