Работал в 6 компаниях 12 лет 1 месяц
Медицина и Здравоохранение, Фармацевтика
Clinical Research Associate II
IQVIA
Медицина и Здравоохранение
9 месяцев
03.2022 - 12.2022
- Performs Initiation, routine Monitoring and Close-out site visits and ensuring data standardsare met.??
- Ensures that the investigator adheres to the study protocol, current GCP guidelines andregulatory requirements during study conduct.??
- Supporting in the tracking of subjects enrolment at each trial site, and providing managementwith detailed reports of clinical activities as requested.??
- Conducting regularly scheduled site management calls with study sites to support the sites’execution according to their responsibilities.??
- Train site staff on protocol, study related procedures and expectations.??
- Manages data collected from clinical sites, including diagnostic images and the resolution ofdata queries.??
- Experienced in CTMS, Medidata, IxRS.??
- Therapeutic experience includes neurology (Multiple Sclerosis), oncology (Bladder cancer;Urothelial carcinoma) studies.
Clinical Research Associate I, Clinical Research Associate II
Global Clinical Trials
Медицина и Здравоохранение
1 год 9 месяцев
06.2020 - 03.2022
- Performs Initiation, Monitoring, Close-out site visits and ensuring data standards are met.??
- Preparation of site visit reports and Protocol Deviation log in required deadlines.??
- Conducting regularly scheduled site management calls with study sites to support the sites’execution of their study responsibilities.??
- Reporting study progress, escalating issues related to the protocol according to the Companyand Sponsor timelines and quality.??
- Follow up on outstanding documents/issues or action items identified during onsite visits andassess progress with action plan to resolve.??
- Train site staff on protocol, study related procedures and expectations.?? Preparation of submissions and notifications to Ethics Committees/ Regulatory Authorities.??
- Follow up on investigational product/study supplies shipment.??
- Preparation and maintenance of Investigator Study File.??
- Preparing and reviewing Agreements with Investigators, sites.??
- Preparing sites and Investigators grants.??
- Experienced in EDC (DATATRAK), ERT, IWRS, MSB, Flex Databases.?? Reconciliation visits to Local Depot.??
- Assisted in the conduct of internal Trial Master File audit, in accordance with applicable SOPsand regulations/guidelines.??
- Therapeutic experience includes gastroenterology (chronic pancreatitis), pulmonology(idiopathic pulmonary fibrosis) studies.
Quality Executive
GlaxoSmithKline Ukraine / ГлаксоСмітКляйн Україна
Фармацевтика
4 года 7 месяцев
05.2015 - 12.2019
- CAPA and Root Cause Analysis.??
- Audits: Management Monitoring, Independent business monitoring, third-party audits.??
- Risk management.??
- Complaints handling.??
- Deviation handling.??
- Local Incident management, recall simulation.??
- Reagents management.??
- Organization of laboratory control for vaccines and medicinal products.??
- Maintenance of contracts with laboratories.
- Maintenance of “Quality Management System”.??
- CoA verifying of imported medicinal products batches.??
- “Technical Terms of Supply” and “Quality Agreements” coordinator.??
- Author and reviewer of department SOPs and perform GAP-Analysis.
Pharmacist
"Dobroho Dnya", Pharmacy
Фармацевтика
2 года 2 месяца
03.2013 - 05.2015
Pharmacy Chief, Qualified person
Lugyny Central Drugstore
Фармацевтика
1 год 5 месяцев
10.2011 - 03.2013
* Management of incoming quality control of medicines;
* Communication with Distributors;
* Organization of operations in drugstore;
* Managing 9 workers;
* Providing drugstore necessary range;
* Storage control of medicines;
* Record keeping and reporting.
Pharmacist
Lugyny Central Drugstore
Фармацевтика
1 год 3 месяца
07.2010 - 10.2011
Ключевая информация
- PC user: MS Office, Internet, etc.??
- Knowledge of GCP, GMP, GDP, GSP.??
- Ability to work on multiple projects at the same time.??
- Ability to keep tight deadlines and work under pressure.??
- Flexibility and ability to adapt to changes.??
- Attention to detail, scrupulousness.
Учился в 2 заведениях
National University of Pharmacy
Faculty of economics and management, Administrative Management
Харьков, 2015
National University of Pharmacy
Faculty of multicycled education, Pharmaceutical
Харьков, 2013
Владеет языками
Английский
выше среднего
Может проходить собеседование на этом языке
Может проходить собеседование на этом языке
Курсы, тренинги, сертификаты
Pharmacist upgrade training course
Дополнительная информация
Водительское удостоверение
category B
Oleksandr
Oleksandr
Clinical Research Associate/ CRA/ SrCRA

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Киев
Активно ищет работу
полная занятость, проектная работа
Характер работы: удаленная работа, гибридная, в офисе/на месте
Обновлено 1 неделю назад