Irina Rodionova

Line management for group of CRAs, CTCs, COMs: • Recruit, interview and identify experienced personnel • Ensure and oversee proper on‐boarding and off‐boarding of employees, compliance to initial and ongoing trainings • Train and oversee the CORE competencies, ICH‐GCP knowledge, clinical research environment, monitoring, etc. • Ensure direct reports are providing timely and quality deliverables • Ensure direct reports are compliant to the timelines and key business metrics defined by Sponsor

Project management support in EMEA region: • Feasibility • Study Start – Up (Country Level) • Study Budget • Study Oversight • Training and Coaching

Clinical Trials Monitoring: • All aspects of clinical trials monitoring activities from study start-up to study closeout. • Additional activities: Monitoring reports reviewer since Jan 2009; Laboratory supplies management on country level; Investigator Meetings organization; training, mentoring and development of junior employees including tutorial and supervising co-monitoring visits.

All aspects of PA responsibilities (providing routine documents circulation within the current projects, pre-indexation and regular submission of documents for Electronic Study File, update of regular trackers, preparation of Study Files, archiving of Study Files, drug accountability, drug return, re-labelling, keeping correspondence with sponsors, assisting CRAs in getting ready for audits).

Studied simultaneous interpretation English-Russian/Russian-English

Studied English language for teaching purposes