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Our client, an international company, that provides its activity in Clinical Research, is looking for Clinical Research Associate II.
Duties
- Acts as primary local company contact for assigned sites for specific trials.
- Monitoring (including remote monitoring), site management (by study specific systems and other.
- Ensures site staff are trained.
- Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas.
- Ensures site study supplies (such as Non-Investigational Product (IP), lab kits, etc.) are adequate for trial conduct.
- Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs )/Product Quality Complaints (PQCs) are reported within the required reporting timelines and documented as appropriate.
- Collaborates with LTM for documenting and communicating site/study progress and issues to trial central team.
- Ensures accuracy, validity and completeness of data collected at trial sites.
- Attends regularly scheduled team meetings and trainings.
- Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
Requirements
- At least 12 months of independent on-site monitoring in Phase I – III international multicenter trials (strongly preferred).
- English upper intermediate.
- Education: University degree, health-science related (e.g. medicine, pharmacology, biology etc) is strongly preferred.
- Readiness for business trips in Ukraine
Job conditions
- official employment
- home based work option
- competitive salary
- “Elite” class health insurance (for employee and his/her children under 18)
- life insurance
- lunch allowance
- fitness allowances
- car for business trips
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