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ЗарегистрироватьсяWas more than two weeks ago
Female, 46 years, born on 29 March 1980
Saint Petersburg, not willing to relocate, prepared for business trips
Старший специалист клинических исследований
170 000 ₽ in hand
Specializations:
- Other
Employment type: full time
Work experience 18 years 8 months
November 2012 — currently
13 years 7 months
AbbVie LLC
Saint Petersburg
Medicine, Pharmaceuticals, Pharmacies... Show more
Старший специалист клинических исследований
• Conduct site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Abbott Standard Operating Procedures (SOPs) and business processes.
• Conduct all clinical site activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to:
• Manage the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas with the ability to manage, with minimal supervision, sites participating in more complex clinical studies and/or sites requiring more oversight of operational issues.
• Manage the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives.
• Ensure quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
• Ensure safety and protection of study subjects according to the monitoring plan, Abbott SOPs, ICH Guidelines, and federal regulations.
• Train study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
• Appropriately escalate serious or outstanding issues to Clinical Operations Manager (COM) or the appropriate project team member(s).
• Facilitate Quality Assurance Audit processes as indicated.
• Ensure regulatory inspection readiness at assigned clinical sites.
• Report monitoring activities and study site conduct accurately and completely. Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner.
• Participate in field training and mentoring of new/junior CRAs. May provide input relative to performance review and development opportunities.
• Identify, evaluate and recommend new/potential investigators/sites on an on-going basis. Partners with CO personnel in the identification of qualified investigators.
• Interact and build professional and collaborative relationships with all study personnel (investigator, study coordinator, pharmacist), peers and office-based personnel. Use multiple technologies to maintain open and frequent communication with Abbott personnel.
• Build relationships with current and potential investigators. Provide training and develop investigators/sites that are new to clinical research. Establish expectations for the conduct of Abbott sponsored clinical trials.
• Proactively identify issues that may impact enrollment and recruitment timelines. Collaborate with senior staff to develop initiatives and contingencies to ensure that timelines are met.
• Participate in departmental meetings.
• Employ good fiscal management to conserve costs of departmental operation and controls travel expenses, with guidance from the COM.
• Identify and partner with other Abbott personnel to develop innovative processes and technologies to increase the quality, productivity, and efficiency of ICFO and conserve overall departmental operating costs.
• Maintain knowledge and expertise across multi-therapeutic areas through clinical and scientific literature review, ongoing awareness of industry practices and participation in professional activities.
• Participate in and or present at departmental or investigator meetings.
• Participate in special projects/work groups.
• Create a positive work environment by encouraging mutual respect, innovation, and accountability at all levels.
July 2010 — October 2012
2 years 4 months
Moscow, www.abbott.com
Medicine, Pharmaceuticals, Pharmacies... Show more
специалист клинических исследований
Manage activities of clinical investigative sites as they relate to Abbott clinical studies to ensure successful execution of the protocol.
Conduct site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Abbott Standard Operating Procedures (SOPs) and business processes.
• Conduct all clinical site activities according to the monitoring plan and in accordance with the study timelines and company objectives.
• Manage the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas.
• Manage the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives.
• 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.
• Ensure safety and protection of study subjects according to the monitoring plan, Abbott SOPs, ICH Guidelines, and federal regulations.
• Train study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
• Appropriately escalate serious or outstanding issues to senior level CRA/Clinical Operations Manager (COM) or the appropriate project team member(s).
• Facilitate Quality Assurance Audit processes as indicated.
• Ensure regulatory inspection readiness at assigned clinical sites.
• Report monitoring activities and study site conduct accurately and completely. Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner.
• Interact and build professional and collaborative relationships with all study personnel (investigator, study coordinator, pharmacist), peers and office-based personnel. Use multiple technologies to maintain open and frequent communication with Abbott personnel.
• Identify, evaluate and recommend new/potential investigators/sites on an on-going basis. Potential sites may be identified through networking or internal Abbott requests to assist in the placement of planned clinical studies with qualified investigators.
• Participate in departmental meetings.
• Employ good fiscal management to conserve costs of departmental operation and controls travel expenses, with guidance from senior level CRA/COM.
• Identify and partner with other Abbott personnel to develop innovative processes and technologies to increase the quality, productivity, and efficiency of Abbott ICFO and conserve overall departmental operating costs.
• Maintain knowledge and expertise across multi-therapeutic areas through clinical and scientific literature review, ongoing awareness of industry practices and participation in professional activities.
• Create a positive work environment by encouraging mutual respect, innovation, and accountability at all levels.
October 2007 — July 2010
2 years 10 months
ClinStar Europe LLC, Branch Office
Moscow, www.clinstar.com
Medicine, Pharmaceuticals, Pharmacies... Show more
специалист клинических исследований
Manage activities of clinical investigative sites as they relate to clinical studies to ensure successful execution of the protocol.
Conduct site initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and Standard Operating Procedures (SOPs) and business processes.
• Conduct all clinical site activities according to the monitoring plan and in accordance with the study timelines and company objectives.
• Manage the activities of clinical investigative sites across multiple protocols and multiple therapeutic areas.
• Manage the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives.
• 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.
• Ensure safety and protection of study subjects according to the monitoring plan, SOPs, ICH Guidelines, and federal regulations.
• Train study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
• Appropriately escalate serious or outstanding issues to senior level CRA/Clinical Operations Manager (COM) or the appropriate project team member(s).
• Facilitate Quality Assurance Audit processes as indicated.
• Ensure regulatory inspection readiness at assigned clinical sites.
• Report monitoring activities and study site conduct accurately and completely. Prepare and submit written reports, both monitoring and administrative, in a timely, concise and objective manner.
Participate in departmental meetings
Skills
Skill proficiency levels
About me
Путешествия, фото, активный отдых, туризм
Higher education
2006
Higher education
не применимо, психиатрия
2003
Higher education
лечебный, врач общей практики
Languages
Citizenship, travel time to work
Citizenship: Russia
Permission to work: Russia
Desired travel time to work: Doesn't matter
