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№ 21743625Обновлено 23 августа 2016
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Clinical Research Associate

110 000 Р
Муж., 39 лет (17 июня 1978), высшее образование, женат, есть дети
Москва
Готов к командировкам, гражданство: Россия
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Опыт работы 10 лет и 9 месяцев
1 год и 3 месяца
июнь 2015 — август 2016
Специалист по клиническим исследованиям
АО ГЕНЕРИУМ, Москва, полная занятость
Conduct and reporting of pre-study, initiation and routine monitoring visits
Communication with investigational sites and sites management
Ensuring the integrity of clinical data in adherence to all applicable regulatory guidelines, company’s SOPs and project-specific operating procedures
Assistance in feasibility studies
Negotiations of clinical trials agreements with the investigator sites and study budgets
Obtaining and review of required study documents from investigational sites
Project-specific training of sites and teams
7 месяцев
декабрь 2014 — июнь 2015
Специалист по клиническим исследованиям
MDP-group, Кемерово, полная занятость
Monitor clinical trials to ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures
Site management to ensure proper adherence to protocol, source data verification and assess CRF entries
Develop, review and edit clinical trial related documentation including but not limited to; Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists
Assist with study protocol design, development and / or review if required
Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required
Perform pre-study initiation, interim monitoring and close out visits as required
Carry out drug formulation administration procedures and documentation records
Ensure adequacy of drug shipment and drug accountability
Liaise with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required
Organise / attend investigator meetings as required
Provide support to the Project Manager / Country Manager with ad-hoc tasks as required
1 год и 1 месяц
февраль 2013 — февраль 2014
Key Account Manager
EuroService, Кемерово, полная занятость
• Market research in the fixed territory, determination of key clients, assessment of their potential, creation of sales forecasts;
• Sales plan accomplishment in the fixed territory;
• Establishment and maintenance of relations with hospitals, regular visits to existing and prospective clients, forming of requirement for hospitals departments;
• Increase of knowledge of company products according to marketing plans;
• Inclusion of preparations in hospital forms and treatment standards;
• Establishment and development of contacts with KOL;
• Organization and participation in marketing efforts (conference, round tables, schools, master classes);
• Maintaining plans and reports according to the established procedures.
1 год и 1 месяц
ноябрь 2011 — ноябрь 2012
Clinical Research Associate II
Worldwide Clinical Trials , Кемерово, полная занятость
• Collect Site Regulatory Documents and perform primary Quality Control of SRD;
• Perform all kinds of investigator site visits, manage investigator sites between visits;
• Assure adherence to the protocol, GCPs, SOPs and take necessary action to bring about compliance;
• Handle CRFs and DCFs and perform in-house CRF review;
• Facilitate adverse event reporting;
• Participate in preparation for and to assist during audit/inspection at investigator sites;
• Assist in preparation for and to participate in Investigator meetings and participate in study team meetings;
• Maintain a site specific part of the Trial Master File;
• Participate in feasibility studies.
2 года и 2 месяца
октябрь 2009 — ноябрь 2011
Clinical Research Associate
MMS, Москва, частичная занятость
Collect Site Regulatory Documents, Perform all kinds of investigator site visits, and manage investigator sites between visits; Facilitate adverse event reporting; Assist in preparation for and to participate in Investigator meetings and participate in study team meetings.
6 лет и 10 месяцев
январь 2005 — октябрь 2011
Development Manager, Clinical Operations Department
Agni, Кемерово, полная занятость
Planning of sales, plan monitoring; Coaching sales representatives, making a list of tasks for sales representatives followed by monitoring and dual visits; Work with marketing department to expand the matrix of the Price by attracting new suppliers; Control over pricing; Work with VIP-clients; Development of promotional campaigns for clients.
Высшее образование
2000
Кемеровская государственная медицинская академия
Фарм
Дневная/Очная форма обучения
Провизор
Курсы
2015
GCP training
Москва
2010
MMS, Moscow, Russia.
Monitoring surveillance programs for patients with schizophrenia.
Москва
Навыки и умения
Иностранные языки
Английский (разговорный).
Водительское удостоверение
Категория B
Профессиональные навыки
Clinical Trials Experience

Short description: Open multicenter randomized comparative study. 4 sites/43 patients
Therapeutic area: Therapy
Indication: Anemia in patients with chronic kidney disease
Phase: III
Function: Full monitoring responsibilities
Time: December14 – March15

Short description: International multicenter randomized comparative study. 2 sites/20 patients in both sites (Monitored me)
Therapeutic area: Psychiatry
Indication: Schizophrenia
Phase: II
Function: Full monitoring responsibilities starting from feasibility
Time: March 12 – Nov 12

Short description: International Double-Blind Multicenter placebo-controlled comparative study. 8 sites, 500+pts (Monitored me)
Therapeutic area: Cardiology
Indication: Myocardial infarction
Phase: III
Function: Full monitoring responsibilities
Time: Nov 11 – nov 12

Short description: International Double-blind, Multicenter, Comparative Study 5 sites, 60pts (Monitored me)
Therapeutic area: Neurology
Indication: Multiple sclerosis
Phase: III
Function: Full monitoring responsibilities
Time: Nov 11 – nov 12

Short description: International Double-blind, Multicenter, Comparative Study, 2 sites, 14pts (Monitored me)
Therapeutic area: Endocrinology
Indication: Diabetes mellitus
Phase: III
Function: Phone monitoring
Time: Sep 12 – nov 12

Short description: Double-blind, Multicenter, Comparative Study, 2 sites, 8 pts (Monitored me)
Therapeutic area: Genecology
Indication: Controlled ovarian hyperstimulation
Phase: IV
Function: Full monitoring responsibilities from start-up
Time: April 09-oct 11

Short description: Multicenter randomized comparative study. 1 site, 14 pts (Monitored me)
Therapeutic area: Psychiatry
Indication: Schizophrenia
Phase: IV
Function: Full monitoring responsibilities till close-out visit
Time: Oct 09 – march 11

Short description: Double-blind, Multicenter, Comparative Study, 2 sites, 19 pts (Monitored me)
Therapeutic area: Cardiology
Indication: Myocardial infarction
Phase: IV
Function: Full monitoring responsibilities incl. close-out visits
Time: Oct 09 – june 11

My hobbies include swimming, skiing, cycling, hiking, fishing.
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Резюме № 21743625 в открытом доступе Последнее обновление 23 августа 2016, 15:15

Резюме

Clinical Research Associate 110 000
Готов к командировкам.
Дата рождения: 17 июня 1978, 39 лет. Женат, есть дети, гражданство Россия.
Москва
06.2015—08.2016   1 год 3 месяца
Специалист по клиническим исследованиям
АО ГЕНЕРИУМ, г. Москва, полная занятость.
Conduct and reporting of pre-study, initiation and routine monitoring visits
Communication with investigational sites and sites management
Ensuring the integrity of clinical data in adherence to all applicable regulatory guidelines, company’s SOPs and project-specific operating procedures
Assistance in feasibility studies
Negotiations of clinical trials agreements with the investigator sites and study budgets
Obtaining and review of required study documents from investigational sites
Project-specific training of sites and teams
12.2014—06.2015   7 месяцев
Специалист по клиническим исследованиям
MDP-group, г. Кемерово, полная занятость.
Monitor clinical trials to ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures
Site management to ensure proper adherence to protocol, source data verification and assess CRF entries
Develop, review and edit clinical trial related documentation including but not limited to; Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists
Assist with study protocol design, development and / or review if required
Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required
Perform pre-study initiation, interim monitoring and close out visits as required
Carry out drug formulation administration procedures and documentation records
Ensure adequacy of drug shipment and drug accountability
Liaise with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required
Organise / attend investigator meetings as required
Provide support to the Project Manager / Country Manager with ad-hoc tasks as required
02.2013—02.2014   1 год 1 месяц
Key Account Manager
EuroService, г. Кемерово, полная занятость.
• Market research in the fixed territory, determination of key clients, assessment of their potential, creation of sales forecasts;
• Sales plan accomplishment in the fixed territory;
• Establishment and maintenance of relations with hospitals, regular visits to existing and prospective clients, forming of requirement for hospitals departments;
• Increase of knowledge of company products according to marketing plans;
• Inclusion of preparations in hospital forms and treatment standards;
• Establishment and development of contacts with KOL;
• Organization and participation in marketing efforts (conference, round tables, schools, master classes);
• Maintaining plans and reports according to the established procedures.
11.2011—11.2012   1 год 1 месяц
Clinical Research Associate II
Worldwide Clinical Trials , г. Кемерово, полная занятость.
• Collect Site Regulatory Documents and perform primary Quality Control of SRD;
• Perform all kinds of investigator site visits, manage investigator sites between visits;
• Assure adherence to the protocol, GCPs, SOPs and take necessary action to bring about compliance;
• Handle CRFs and DCFs and perform in-house CRF review;
• Facilitate adverse event reporting;
• Participate in preparation for and to assist during audit/inspection at investigator sites;
• Assist in preparation for and to participate in Investigator meetings and participate in study team meetings;
• Maintain a site specific part of the Trial Master File;
• Participate in feasibility studies.
10.2009—11.2011   2 года 2 месяца
Clinical Research Associate
MMS, г. Москва, частичная занятость.
Collect Site Regulatory Documents, Perform all kinds of investigator site visits, and manage investigator sites between visits; Facilitate adverse event reporting; Assist in preparation for and to participate in Investigator meetings and participate in study team meetings.
01.2005—10.2011   6 лет 10 месяцев
Development Manager, Clinical Operations Department
Agni, г. Кемерово, полная занятость.
Planning of sales, plan monitoring; Coaching sales representatives, making a list of tasks for sales representatives followed by monitoring and dual visits; Work with marketing department to expand the matrix of the Price by attracting new suppliers; Control over pricing; Work with VIP-clients; Development of promotional campaigns for clients.
Высшее
2000
Кемеровская государственная медицинская академия
Факультет: Фарм
Дневная/Очная форма обучения
Специальность: Провизор
Курсы и тренинги
2015
GCP training
Москва
2010
MMS, Moscow, Russia.
Monitoring surveillance programs for patients with schizophrenia.
Москва
Навыки и умения
Иностранные языки
Английский (разговорный).
Водительское удостоверение
B
Профессиональные навыки
Clinical Trials Experience

Short description: Open multicenter randomized comparative study. 4 sites/43 patients
Therapeutic area: Therapy
Indication: Anemia in patients with chronic kidney disease
Phase: III
Function: Full monitoring responsibilities
Time: December14 – March15

Short description: International multicenter randomized comparative study. 2 sites/20 patients in both sites (Monitored me)
Therapeutic area: Psychiatry
Indication: Schizophrenia
Phase: II
Function: Full monitoring responsibilities starting from feasibility
Time: March 12 – Nov 12

Short description: International Double-Blind Multicenter placebo-controlled comparative study. 8 sites, 500+pts (Monitored me)
Therapeutic area: Cardiology
Indication: Myocardial infarction
Phase: III
Function: Full monitoring responsibilities
Time: Nov 11 – nov 12

Short description: International Double-blind, Multicenter, Comparative Study 5 sites, 60pts (Monitored me)
Therapeutic area: Neurology
Indication: Multiple sclerosis
Phase: III
Function: Full monitoring responsibilities
Time: Nov 11 – nov 12

Short description: International Double-blind, Multicenter, Comparative Study, 2 sites, 14pts (Monitored me)
Therapeutic area: Endocrinology
Indication: Diabetes mellitus
Phase: III
Function: Phone monitoring
Time: Sep 12 – nov 12

Short description: Double-blind, Multicenter, Comparative Study, 2 sites, 8 pts (Monitored me)
Therapeutic area: Genecology
Indication: Controlled ovarian hyperstimulation
Phase: IV
Function: Full monitoring responsibilities from start-up
Time: April 09-oct 11

Short description: Multicenter randomized comparative study. 1 site, 14 pts (Monitored me)
Therapeutic area: Psychiatry
Indication: Schizophrenia
Phase: IV
Function: Full monitoring responsibilities till close-out visit
Time: Oct 09 – march 11

Short description: Double-blind, Multicenter, Comparative Study, 2 sites, 19 pts (Monitored me)
Therapeutic area: Cardiology
Indication: Myocardial infarction
Phase: IV
Function: Full monitoring responsibilities incl. close-out visits
Time: Oct 09 – june 11

My hobbies include swimming, skiing, cycling, hiking, fishing.