Senior CRA Client-Dedicated Moscow Russia
- Experience Level
- Experienced (non-manager)
Here at Syneos Health we are currently recruiting for a Clinical Research Associate to be fully dedicated to our global Pharma client.
Sr CRA acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.
Responsibilities will include:
• Develop strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Perform clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gain an in-depth understanding of the study protocol and related procedures.
• Perform remote and on-site monitoring & oversight activities
• Conduct site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and record clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
• Collect, review, and monitor required regulatory documentation for study start-up, study maintenance and study close-out.
• Communicate with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
• Support and/or lead audit/inspection activities as needed.
• B.A./B.S. required with strong emphasis in science and/or biology
• Minimum 2 years of direct site monitoring experience in a bio/pharma/CRO
• Fluent in Russian and English (verbal and written) and excellent communication skills.
• Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
• Effective time management, organizational and interpersonal skills, conflict management, problem solving skills
• Ability to travel up to 75% of working time
We offer highly competitive remuneration and have a comprehensive benefits package, which includes family medical insurance, car allowance, additional vacation days and lunch allowance.
Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.