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:
Routine Monitoring 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.
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
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