Clinical Trial Coordinator

Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Join Us as a Clinical Trial Coordinator – Make an Impact at the Forefront of Innovation
What You’ll Do
Clinical Trial & Documentation Support

• Coordinate and complete assigned clinical trial activities in accordance with the study task matrix.
• Perform Country and Investigator file reviews and document findings in the appropriate systems.
• Support audit and inspection readiness by ensuring study files are reviewed according to applicable schedules and procedures.
• Ensure assigned activities are completed on time and to a high-quality standard, proactively communicating potential risks to project leads.
• Process and maintain clinical trial documentation within the electronic Trial Master File (eTMF).
• Review eTMF documentation and support the resolution of missing, incomplete, or outstanding documentation.
• Analyze findings reports and assist with the clarification and resolution of site documentation findings.
• Support the preparation, compilation, and distribution of Investigator Site Files (ISFs), pharmacy binders, and study supplies.
• Assist with study-specific translations and translation quality control, as required.
  

• Provide administrative support for site activation and start-up activities.
• Work with internal teams to help ensure site start-up activities remain aligned with the site’s activation critical path and project timelines.
• Support regulatory submissions and the tracking of local regulatory documentation.
• Transmit required documentation to clients and centralized Institutional Review Boards (IRBs)/Independent Ethics Committees (IECs), as applicable.
• Maintain accurate and timely records of site communications, contact attempts, follow-ups, and survey responses.
• Review survey information to help ensure responses are complete, accurate, and relevant.
• Support effective site follow-up plans and escalate concerns or potential risks appropriately.
• Liaise with relevant internal teams to support the timely resolution of investigator queries.
  

• Provide support for clinical trial systems such as Activate, eTMF, and other study platforms.
• Help ensure study databases and systems remain accurate and up to date.
• Maintain study-specific documentation, team lists, project training requirements, activity plans, and vendor trackers.
• Support Risk-Based Monitoring (RBM) activities where applicable.
• Assist with scheduling internal and client meetings as required.
• Support study communications, including document distribution, reports, and project-specific mailings.
• Collaborate closely with project team members to achieve targeted study milestones and deadlines.
• Communicate site-related issues and potential risks to appropriate clinical and project colleagues.
  

• High school/secondary school diploma or equivalent relevant academic or vocational qualification.
• Additional university-level education in life sciences, healthcare, or a related discipline is an advantage.
• Previous relevant experience may be beneficial; however, candidates who demonstrate the appropriate knowledge, skills, and motivation to develop within clinical research may also be considered.
• Equivalent combinations of education, training, and directly related experience may be considered.
  

• Strong organizational skills and excellent attention to detail.
• Ability to manage multiple tasks efficiently while working to project deadlines.
• Ability to analyze project-specific information and systems to ensure accuracy and completeness.
• Strong customer-focused mindset.
• Flexibility and adaptability to changing priorities and study timelines.
• Interest in developing a strong working knowledge of ICH-GCP, applicable Italian and European regulations, and clinical research procedures.
• Good written and spoken English, together with proficiency in the local language as required.
• Effective written and verbal communication skills.
• Strong interpersonal skills and the ability to collaborate effectively with cross-functional and international teams.
• Good computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint.
• Ability to quickly learn and confidently work with clinical trial databases and systems.
• Good judgment, problem-solving, and decision-making skills.
• Ability to follow study-specific procedures and project instructions accurately.
• Ability to identify potential risks and escalate