Senior Clinical Research Associate

Our client, an international company, that provides its activity in Clinical Research, is looking for Senior Clinical Research Associate

Duties

• Acts as primary local company contact for assigned sites for specific trials.
• Responsible for executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring). 
• Responsible for the implementation of analytical risk based monitoring model at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
• Ensures site staff are trained.  
• Ensures accuracy, validity and completeness of data collected at trial sites
• 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. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
• Attends regularly scheduled team meetings and trainings.
• Works closely with LTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality
• Assurance (QA) site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV).
• Acts as a point of contact in site management practices.
• May be assigned as a coach and mentor to a less experienced site manager.
• Leads and/or participates in special initiatives as assigned.

Requirements

• At least 3 years of independent on-site monitoring in Phase I – III international multicenter trials
• 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 allowance
• car for business trips