Senior Clinical Research Associate

Senior Clinical Research Associate

ICON

Sofia, Bulgaria

We are looking to recruit an experienced Senior Clinical Research Associate to join our ICON FSP team and work in a sponsor dedicated role for a global biopharmaceutical company who are the leader in fastest growing modern healthcare such as cell & gene therapies (CGT), oncology, cardiology, women's health, hematology, and ophthalmology.

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.
• The CRA is 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.
• The CRA proactively identifies potential issues and develops site Corrective Actions / Preventive Actions (CAPAs) and ensures timely and sufficient resolution of issues that may impact compliance or quality of study related activities or data.
• As key contributor to the Trial Master File and study documents at the country level, ensures essential documents are appropriate and filed in a timely manner in the Investigator Site File.
• Contributor in the preparation, conduct and follow up of Site Audits and Regulatory Inspections to ensure a successful outcome.

Your profile

• University degree.
• a CRA with a minimum of 3.5 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.
• Ability to work occasionally form the sponsor's office in Sofia.
• Good IT skills.
• Ability to understand and analyze data/metrics and act appropriately.
• Capable of managing complex issues, works in a solution-oriented manner.