Clinical Research Associate

Category: Clinical Development

Location:Bucharest, Romania, RO

• Conducting risk-based site management in accordance with the protocol, monitoring plan, SOPs, relevant legislation and ICH-GCP guidelines, with guidance, assistance and supervision as required. You select the appropriate sites and investigators by conducting site selection visits, you obtain the necessary greenlight documents within timelines together with recruitment planning visits.
• Conduct site initiation visits for the site to start recruitment you are a well-organized, flexible with the ability to tactfully communicate with internal and external stakeholders. You have the ability to find solutions to complex problems with minimum disruption whilst providing a strong support network. You also actively participate in regional, trial team, monitor and investigator meetings.
• Updating and complying with requirements of electronic systems eg: e TMF, e ITF IWRS, EDC and other systems.
• Management of protocol compliance at sites
• Trial supplies management and managing data cleaning process and ensuring data cleaning deadlines are met

• Preferably, minimum 1 year of experience in independent monitoring from a similar position in the pharmaceutical industry or Clinical Research Organisation (CRO). We can consider candidates without experience as well.
• Fluent English, Romanian verbal and writing skills
• Valid driving license B
• Ability to travel around the country
• It will be a plus to have diabetes or obesity knowledge/experience and have a team-oriented personality with high degree of flexibility, open to learn and motivated and energetic.