Контактна інформація

Шукач вказав телефон, ел. пошту та адресу.

Отримати контакти цього кандидата можна на сторінці https://www.work.ua/resumes/2084966

Досвід роботи

Lead Clinical Monitoring

з 10.2016 по нині (7 років 7 місяців)
Biorasi, Київ (CRO)

Monitor clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulations and ICH guidelines
Regularly provide the clinical status information to team members and project management
Ensure that Regulatory applications have been submitted and approvals received (submissions/notifications to National Health Authorities, Submission to IRB/ Ethics Committees, update submissions, e.g. protocol amendments, safety reports). Deal with Regulatory Branch for timely results
Organize delivery of investigations product, laboratory packs, CRFs and other study specific materials to and from the clinical sites
To be a first line of communication to Vendors. Participate in the vendor / site audits as required
To lead and partake in regular team meeting / teleconferences
Communicate any out of scope issues to upper management as soon as identified
Assist, as appropriate, with reporting site performance regarding timelines and deliverables the clinical project team meetings and assist with feedback information on study organization and conduct for analysis of overall study performance
Mentoring the Associates on the subjects of job performance, trainings and professional growth

CRA II

з 09.2015 по 05.2016 (8 місяців)
ICON Clinical Research, Киев (Clinical Research)

Responsibilities include: identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP involvement, when required, in other areas of study management and staff training and contribute to the review of ICON systems and procedures, as appropriate.
Contribute to the culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. Recognize, exemplify and adhere to ICON’s values which center around a commitment to People, Clients and Performance.

Senior Clinical Research Associate

з 10.2008 по 08.2013 (4 роки 10 місяців)
PAREXEL Ukraine LLC, Kyiv Ukraine (Clinical Research Organisation)

Coordinating work of the study team in Ukraine as country coordinating CRA. Close work with study startup team including but not limited to ICF customization and SRP preparing. Clinical monitoring and management of 22 sites recruited 327 patients including but not limited to investigator/site selection/qualification, initiation, monitoring and termination, in accordance with PAREXEL´s SOPs, ICH GCP and Local Regulations. Detailed regular reporting to study team regarding enrollment status, visit reports, site contacts reports. Performing preventive and corrective actions, if necessary. Preparation to audit. Central File management and QC. Responsibility enclosing financial aspects of the study, working closely with Medical Department. Participating in business development activities including feasibility, consultation on bid development and estimation of critical success factors, scientific background, workload and timelines, personal participation in bid defense meetings. Development of study related documents – Monitoring Plan, Safety reporting Plan, instructions for investigators, presentation materials for investigator meetings etc. Supervising and support of Regulatory/CEC submission process

Clinical Research Associate II

з 10.2007 по 10.2008 (1 рік)
PAREXEL Ukraine LLC, Kyiv Ukraine (Clinical Research Organisation)

Clinical trials monitoring in accordance with the ICH guidelines, the current monitor guidelines and SOP’ s including: identifying sites, preparing documentation for necessary approvals, initiating sites and observing recruitment, monitoring of sites, reporting visits and contacts with site, assuring the presence of all relevant documents on site, collaborating with other departments to report safety information, collecting case report forms, follow-up and solving data queries, reporting the progress of the study on a regular basis and performing site close-out visits. Additionally were performed 15 Feasibilities.

Clinical Research Associate I

з 10.2005 по 10.2007 (2 роки)
PAREXEL Ukraine LLC, Kyiv Ukraine (Clinical Research Organisation)

Responsibilities include: site selection, initiation and qualification, blinded and unblinded clinical study monitoring, performing site close-out visits, data collection and clarification, quality control, review of data collected at trial sites to ensure compliance with protocol and GCP guidelines in the world wide study with top number of patients in Ukraine.

Clinical Immunologist, Predoctoral Research Associate

з 01.2003 по 10.2005 (2 роки 9 місяців)
Scientific Research Laboratory Center of National Medical University named after O.O. Bohomolets, Department of Immunology (Conducting of scientific research in immunology field)

Performing diagnostic tests and treatment of conditions including chronic infection, autoimmune diseases, allergy, radiotherapy, chemotherapy and transplantation. I was involved in development of new diagnostic and treatment methods of the patients suffering from Herpes Simplex virus infection.

Освіта

Interregional Academy of Personnel Management

Practical Psychology, Sevastopol'
Вища, з 2008 по 2011 (3 роки 1 місяць)

Qualification of Specialist in Practical Psychology;

D. Galitsky State Medical University

Specialist in Clinical Immunology, Lviv, Ukraine
Вища, з 2004 по 2004 (3 місяці)

Qualification of Specialist in Clinical Immunology;

National Medical University named after O.O. Bohomolets

Internal Medicine, Kyiv, Ukraine
Вища, з 1999 по 2000 (9 місяців)

Qualification of Specialist in Internal Medicine;

State Medical Academy

MD, Ivano-Frankivsk, Ukraine
Вища, з 1992 по 1998 (5 років 9 місяців)

MD

Додаткова освіта та сертифікати

Schiller International University, London, Fundamentals of International Marketing, Fundamentals of Information technologies

2000, 2 month

Знання і навички

Знання мов

• Англійська — просунутий
• Українська — вільно

Рекомендації

A. Zhmuro (available upon request)

A. Zhmuro (available upon request)

Country Manager, PAREXEL

Додаткова інформація

Therapeutic Areas of Experience

- Infectious Diseases
- Gastroenterology
- Cardiology
- Psychiatry
- Oncology
- Pulmonology
- Immunology
- Allergology
- Neurology

Special experiences

- Mentoring and couching the less experienced CRAs
- Contract management of the clinical studies
- Regulatory management of the clinical studies/ strong knowledge of clinical research regulations and practices
- Developing of strategic plans for clinical studies, forecast timelines, budgets, resource needs in alignment with the Clinical Operations Team objectives