inVentiv Health is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 36 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing from a single clinical professional to an entire functional team.
Role: Clinical Research Associate I/II
Location: Italy, office-based in Milan
Contract: permanent, full-time
Perform site visits and monitor activities in accordance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements. Mentor CRAs on monitoring, internal procedures, and query resolution. Use expertise and judgement to identify and resolve complex site issues and deficiencies in documentation, communication, and the need for additional training. Assess and ensure overall integrity of study and adherence to guidelines, protocols, and regulations. Evaluate overall performance of site and site staff. Ensure compliance and understanding of study requirements by site staff. Provide recommendations regarding site-specific actions and use judgment and expertise to assess ability of site staff. Interpret data to identify protocol deviations or major risks to data integrity. Understand project scope, budgets, and timelines and be able to provide input and manage project objectives to meet timelines. Act as a liaison between the company and study site personnel and be able to respond to site concerns and questions. Review and verify case report forms and other clinical data for completeness and accuracy. Monitor patient safety and identify and address any protocol deviations and make appropriate recommendations. Generate queries and manage resolutions with site staff. Maintain project tracking systems as required. Participate in the identification and selection of investigators and clinical sites. Assist in the development of study specific monitoring procedures and guidelines. Mentor junior staff on training, guidelines, and processes. Complete assigned training programs and apply learning. Maintain working knowledge of GCP/ICH Guidelines as well as all applicable regulations?
Bachelor's degree or RN in a related field or equivalent combination of education, training and experience Two or three years prior clinical monitoring experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Strong organizational skills Ability to demonstrate good computer skills. Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade Willingness to travel
Compensation & Benefits Overview
Opportunity to be a part of international team and experience working in one of inVentiv's main offices in EMEA - in Milan, Italy. A competitive remuneration package with excellent benefits. A commitment to your development and training, with the opportunity to progress your career within a market leading and innovative organisation. The opportunity to work within a successful and rewarding environment.
For more details please contact Magdalena Raczynska on