Clinical Research Associate

Clinical Research Associate

ICON

Bucharest or Remote, Romania

What you will be doing:

• Site management and monitoring activities for assigned applicable Phase I and all Phase II-IV clinical Investigator sites
• Conducts remote and onsite visits including but not limited to initiation visits, monitoring visits, close-out visits
• Managing Investigator site and site activities and monitoring site data, to ensure patient safety and ethical and regulatory compliance to provide quality data required for global regulatory submissions for approval of drugs
• Managing Investigator sites to ensure the Investigator and Site Staff meet all aspects of study delivery and commitments to make certain the operational study execution is on track from site selection to site close out
• You will be responsible for training the Investigator and site staff on these strict regulatory regulations and procedures for timely reporting and as well as ensuring ongoing compliance
• Contributor in the preparation, conduct and follow up of Site Audits and Regulatory Inspections to ensure a successful outcome

Your Profile:

• University degree
• Minimum of 4+ years of independent on-site monitoring experience in a bio/pharma/CRO
• Proven Skills in Site Management including management of site performance and patient recruitment
• Good IT skills
• Ability to understand and analyze data/metrics and act appropriately
• Capable of managing complex issues, works in a solution-oriented manner
• Ability to travel at least 60% of the time and should possess a valid driver’s license