Clinical Research Associate

Our Clinical Research team push the boundaries of global healthcare through research and innovation in Albania and the Balkan peninsula. Through clinical trials conducted, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine. The role is accountable for Clinical Trial in Neurology for 2 Clinical Trial Sites with assigned protocol in Tirana, Albania. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility for allocated sites. Job Description - Performs clinical study site management/monitoring activities in compliance with ICH-GCP and associated documents & regulations - Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out - Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance - Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required - Supports and/or leads audit/inspection activities as needed - Following the country strategy defined by CRD and CRA manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities Qualifications - B.A./B.S. with a strong emphasis on science and/or biology is preferred - Fluent in Local Languages 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. - Min. 1 year of independent monitoring experience in a bio/pharma/CRO - Ability to travel domestically and internationally approximately 65%-75% of working time. Expected travelling ~2-3 days/week - Current driver’s license For Applicants - We do not accept candidates working in multiple companies - We accept only candidates for Office based Position - We accept only candidates with previous Monitoring Experience Who We Are … Rosenbaum Group is a CRO Start-up from Central Europe established in 2019. Within its short time of existence, it has expanded across the Balkan peninsula and Turkey supporting our clients in Albania, Austria, Bulgaria, Germany, Greece and Turkey. We are a fast-growing company that is searching for people with a passion for Clinical Research that can help grow our vision. If you want to become a member of fast growing company and contribute to the Clinical Research in Greece submit your CV! Burimi: https://www.linkedin.com/jobs/view/4470537563/

Niveli: mid level