Вакансия № 10954338 на должность "Clinical Research Associate" в городе (регионе) Санкт-Петербург, Россия от компании "Docs" на сайте Электронный Центр Занятости Населения
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Обязательное требование к опыту работы искомого сотрудника: 1–3 года.
График работы: полный день.
Тип занятости: полная занятость.
Вакансия № 10954338 добавлена в базу данных: Понедельник, 15 апреля 2024 года.
Дата обновления этого объявления: Четверг, 25 апреля 2024 года.
| Рейтинг вакансии: 11,96 из 100 баллов |
Работодатель предложит заработную плату по результатам собеседования с соискателем работы.
A Site Manager is the person in Trial Co-ordination and Site Management that serves as a primary contact point between the sponsor and the investigational site. A Site Manager is assigned to trial sites ensuring inspection readiness through compliance with the clinical research protocol, company's Standard Operating Procedures (SOP), codes of Good Clinical Practice (GCP), applicable regulations and guidelines from start-up through data-base lock. Responsibilities include site selection, pretrial assessment, subject recruitment and retention planning, site initiation, monitoring and close-out. Partner with the CTA/IDA, LTM and GTM to ensure overall site management while performing trial related activities for assigned protocols. May contribute to process improvement and training.
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Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
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Acts as primary local company contact for assigned sites for specific trials.
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Attends/participates in investigator meetings as needed.
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Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
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Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases
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Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
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Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
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Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
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Arranges the appropriate destruction of clinical supplies
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Ensures site staff complete the data entry and resolve queries within expected timelines.
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Ensures accuracy, validity and completeness of data collected at trial sites
Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensure that they are consistent with all data collected and with the information in the source documents.
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