Clinical Research Monitor

The Clinical Research Monitor is responsible for the oversight of clinical research conducted at investigational sites to ensure compliance with study protocols, applicable regulatory standards, IRB/EC policies and procedures and business policies. This position works under general supervision, working closely with study teams, site personnel and monitoring supervisor for resolution of site issues.


OVERALL OBJECTIVE/ACCOUNTABILITY

• Perform site monitoring visits in accordance with the study Monitoring Plan to ensure compliance with the Investigational Plan, Monitoring Plan, applicable regulatory, IRB/EC, and standards, guidelines and policies.
• Communicate visit findings with site personnel and complete a written letter for distribution to the Principal Investigator and appropriate site personnel for follow-up.
• Prepare site visit reports and correspondence for all visits conducted in accordance with the study Monitoring Plan.
• Identify site needs, provide solutions to facilitate the clinical trial process.
• Act as a primary point of contact for study sites as requested.
• Assist in initial and ongoing site personnel training as required.
• Identification and escalation of protocol deviations, discrepancies in data, and non-compliance to study protocols, applicable regulations, Good Clinical Practices and Standard Operating Procedures.

• Competitive package
• Professional growth opportunity, training and educational workshops
• Cellular phone, company car
• Great working place and company support
• Opportunity to buy company stocks

If you have an interest, similar experiences in relevant environment and fulfill the required knowledge, please send your CV with a motivation letter in English language.
We will contact only candidates who match the profile we are looking for. Thank you for your understanding.