Clinical Research Associate / Senior CRA in Russia (any cities), home-based
Вакансия № 18747490 в населенном пункте (городе) Санкт-Петербург, Россия от компании "Worldwide Clinical Trials" на сайте Мультирегиональный Электронный Центр Занятости Населения (ЦЗН).
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Организация работает в следующих сферах деятельности: Медицина, фармацевтика, аптеки; Услуги для бизнеса; .
Репутация компании "Worldwide Clinical Trials" в отзывах работников:
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Обязательное требование к опыту работы искомого сотрудника: 3–6 лет.
График работы: полный день.
Тип занятости: полная занятость.
Вакансия № 18747490 добавлена в базу данных: Воскресенье, 14 апреля 2024 года.
Дата обновления этого объявления: Пятница, 26 апреля 2024 года.
| Рейтинг вакансии: 27,88 из 100 баллов |
Работодатель предложит заработную плату по результатам собеседования с соискателем работы.
WORLDWIDE CLINICAL TRIALS: We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
SUMMARY: Clinical Research Associate / Senior CRA in Russia: Saint Petersburg, Moscow, Ekaterinburg or other cities, home-based. Responsible for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
RESPONSIBILITIES:
Tasks may include but are not limited to:
- Perform feasibility studies for potential sites as requested
- Conduct pre-study, study initiation and interim monitoring visits in adherence to the protocol requirements
- Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.)
- Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site
- Document site visit findings via written reports
- Assess, monitor, and train study site staff on protocol adherence as required
- Review study subject safety information and informed consent
- Conduct source document verification for compliance, patient safety, and veracity of data
- Review CRFs using paper or electronic data capture systems
- Assist the site in maintenance of the Investigator Site File
- Maintain regular communication with sites
- Provide applicable updates for site related documentation for filing in the Trial Master File (TMF)
- Assist sites in data query resolution
- Ensure site compliance with IP receipt, accountability and return or destruction
- Complete final site close out visit and report
OTHER SKILLS AND ABILITIES:
- Good oral and written communication skills
- Good planning and organizational skills with effective time management
- Good interpersonal skills
- Ability to work in an organized and methodical manner
- Basic understanding of clinical research principles and process
- Basic understanding of FDA and/ or EU Directives and regulations, ICH Guidelines and local regulatory requirements
- Basic knowledge of one therapeutic area, sufficient to function as a CRA
- Good understanding of standard operating procedures
- Basic knowledge of Microsoft Office
- Familiarity with IxRS, EDC systems
REQUIREMENTS:
- Medical Doctor (MD) degree OR
- A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR
- Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and one-year experience with clinical research (e.g. study coordinator, CTA, etc.)
- Relevant experience of CRA / Senior CRA at least 3 years working in an CRO
- Willingness to travel required
- Valid current passport required
- Fluent in the local languages of the countries under responsibilities and proficient in both spoken and written English.
WHAT WE OFFER:
- International environment – more than 60 countries
- Extensive portfolio of clinical trial technology
- Official employment
- Medical insurance with stomatology for associate and one of close relatives
- Sick leave benefit with paid 10 days every year
- Life insurance package
- Supplemental social compensations
- Training & Development, including free online English lessons.
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