от компании (организации): ООО bioRASI в городе (населённом пункте): Москва, Россия
в отрасли экономики "Медицина, фармацевтика" → "Клинические исследования"
с заработной платой: от 170000 руб.
Вакансия № 14514973 добавлена в базу данных сайта Работа в Москве и Московской области (МО, Подмосковье): Пятница, 18 октября 2024 года.
Дата обновления вакансии № 14514973 на сайте Работа в Москве и Московской области (МО, Подмосковье): Среда, 13 ноября 2024 года.
Обращаем Ваше внимание, что на момент обращения к работодателю вакансия № 14514973 может быть уже занята. Администрация сайта Работа в Москве и Московской области (МО, Подмосковье) приносит извинения за доставленные неудобства.
Требования к опыту работы:
3–6 лет
Тип занятости:
полная занятость
График работы:
полный день
Дополнительные сведения о вакансии: Clinical Research Associate (CRA), Moscow
The Clinical Research Associate (CRA) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and bioRASI Standard Operating Procedures.
Conducts site visits to assess protocol and regulatory compliance and manages required documentation Responsible for ensuring that data will pass international quality assurance audits. Represents bioRASI in the global medical research community and develops and maintains collaborative relationships with investigational sites. Required to travel up to 50% on average.
Responsibilities:
· Maintains timely and effective communication among team members and site staff.
· Routinely anticipates/identifies potential issues and implements corrective actions independently. Keeps project leadership apprised of team issues, seeking guidance as needed. Demonstrates effective conflict resolution.
· Regulatory Documentation - Assures compliance with local regulations, Code of Federal Regulations (CFR)/ International Conference of Harmonization (ICH) and GCP guidelines, and Company and Sponsor SOPs. Maintains current regulatory documentation according to Essential Regulatory Document Guidelines and Central File Plan. Participates in Central File and on-site audits as requested. Responds to findings without oversight. May be responsible for submission of regulatory packages to ethics committees and/or competent authorities.
· Monitoring - Responsible for site management and site staff performance including: conducting of pre-study, initiation, routine, and close-out visits all types of clinical trials according to ICH GCP, Sponsor SOPs and applicable local requirements; assures compliance with protocol requirements; assures effective patient identification and recruitment plan is in place; assures timely reporting of Adverse Events (AE)/Serious Adverse Events (SAE) and protocol violations; ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials; regularly reviews the status of the contents of the site regulatory binder; exhibits superior time management skills; may perform training visits with less experienced CRAs; and may perform assessment of less experienced CRAs during the sign-off visits.
· Data Handling - Performs source data verification according to contractual requirements. Assures timely completion and submission of Case Report Forms according to Clinical Monitoring Plan and/or Data Management Plan. Assures timely and accurate completion of Data Clarification Forms. Highly proficient with multiple data capture systems/methodologies in course of monitoring. Performs clinical data listings reviews as needed.
· Reporting and Tracking - completes and submits reports according to SOP/Works Instructions or Sponsor requirements. Maintains awareness of key study performance indicators for sites (Contact Record Forms, patient enrollment, and SAEs). Updates study and patient status information and serves as Clinical Trial Management System resource for Project Manager (PM)/Lead CRA. Tracks Investigator payments/milestones. Documents and tracks the resolution of all outstanding site-specific protocol-related issues from visit to visit.
· Administrative - prepares for and attends Investigator meetings. May present materials, as requested. Assists with the preparation of study start-up materials and tools, as requested. Attends clinical monitoring staff meetings, project team meetings and training sessions according to the project communication, monitoring and/or training plans.
Education and Experience:
· Higher education in science/health care field or equivalent combined education and experience.
· Proven clinical monitoring skills (1+ years experience in clinical development phase II-III)
· Demonstrated understanding of medical/therapeutic area knowledge and medical terminology
· Good spoken and written English, grammar skills
· Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail. Ability to learn appropriate software
· Quick learner, team-player
· Willingness to travel in the country and abroad; travel requirement is up to 70% of working time
· In some cases an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered
· Demonstrated ability to attain and maintain a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures
· Good oral and written communication skills, with the ability to communicate effectively with medical personnel
· Customer focus
· Good organizational and time management skills
· Effective interpersonal skills
· Attention to detail
· Proven flexibility and adaptability
· Ability to work in a team or independently as required
· Good presentation skills
Company offers:
· The company offers attractive salary and social package, great possibilities for carrier and professional growth
Откликнуться на эту вакансию: Clinical Research Associate (CRA), Moscow
Предыдущая вакансия:
Вакансия № 14514940 на должность Специалист по проведению клинических исследований от компании ООО Брингер в городе (населенном пункте) Москва