This position primarily presumes being responsible for monitoring (pre-study, initiation, routine, and close-out visits) of investigator sites for compliance to the study protocol, ICH GCP, company’s SOPs and applicable regulations. The responsibilities will also include negotiations with the investigator sites of clinical trials agreements and study budgets, and obtaining and reviewing of required documents from investigator sites.

This position presumes a full scope of monitoring responsibilities:

• Pre-study visits
• Initiation visits
• Routine Monitoring visits
• Close-Out visits
• Assistance in training of Junior CRAs
• PM backup when required
• Assistance in feasibility studies
• Negotiations of clinical trials agreements with investigator sites and study budgets
• Obtaining and reviewing of required study documents from investigator sites.

Conditions:

• We are based in St. Petersburg with representative offices in Moscow and Kiev and are interested in finding full-time employees for all three offices
• Salary is to be determined based on results of the interview

Requirements:

• Medical Doctor
• Fluent English, written and spoken
• Sound management skills
• Minimum of a year of independent monitoring experience in clinical trials is a must
• Ability to travel at least 65% of the working time