Вакансия: Specialist (Clinical Research Monito) in Moscow

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Город, регион, страна: Москва, РФ (населённый пункт) места работы.

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Компания: Medtronic (организация, фирма, ИП);

Логотип (бренд, торговая марка, эмблема) компании (организации, фирмы, ИП):

Репутация работодателя Medtronic:

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Зарплата: по договорённости;

Требования к работнику:

Дополнительные требования:
не указаны

Дополнительное описание вакансии:
Company description: Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future. Job description: For our Clinical Research department we are currently looking for a Clinical Research Monitor (Moscow, Russia) MAIN PURPOSE OF JOB: The Clinical Research Monitor is responsible for the oversight of clinical research conducted at investigational sites to ensure compliance with study protocols, applicable regulatory standards, IRB/EC policies and procedures and business policies. This position works under general supervision, working closely with study teams, site personnel, Medtronic field personnel and monitoring supervisor for resolution of site issues. Required profile: JOB REQUIREMENTS: Bachelor's Degree in life sciences, nursing or other health related Disciplines Two years of Clinical Research experience (if holders of Master's degree candidates with no experience will be considered) PREFERRED QUALIFICATIONS: Experience of conducting clinical research activities in a regulated environment Basic understanding of any applicable regulations (e.g., Good Clinical Practices, ICH guidelines, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive, etc.) Capable of clearly and effectively communicating verbally and in writing Team-player and able to work in a matrix environment where building strong cross-functional relationships is crucial Computer literate (incl. working knowledge of MS Word and MS Excel) Ability to prioritize and adapt to fast-paced environment and shifting priorities Problem-solving skills and high attention to detail Ability to travel up to 80% (incl. international travel) What we offer: MAIN RESPONSIBILITIES: Perform site monitoring visits in accordance with the study Monitoring Plan to ensure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB/EC, and Medtronic standards, guidelines and policies Communicate visit findings with site personnel and complete a written letter for distribution to the Principal Investigator and appropriate site personnel for follow-up Providing input on study protocol, CRFs and other study documents Prepare site visit reports and correspondence for all visits conducted in accordance with the study Monitoring Plan so that all requirements of the Monitoring Plan are met Identify site needs, provide solutions to facilitate the clinical trial process, act as a point of contact for study sites as well as managing site assignments Assist in initial and ongoing site personnel training Identification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, Good Clinical Practices and Standard Operating Procedures Collaborates with monitoring management and study team personnel towards securing Investigator compliance Understand the study protocol and accompanying background information (e.g., Investigator Brochure, Report of Prior Investigations etc.) Facilitating communication and information flow between assigned project teams and assigned monitors on project

Вакансия № 4-826480 относится к сфере деятельности: "Наука, образование" » "Инженерные науки".

Вы можете перейти к просмотру актуальных предложений работы выбранного населенного пункта с учетом сферы деятельности вакансии № 4-826480: "Наука, образование в населенном пункте текущего места труда" » "Инженерные науки в населенном пункте текущего места труда".

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