Completes project activities associated with monitoring functions of Phase I through Phase IV clinical research studies while continuing to develop knowledge of drug development process, ICH/GCP and applicable local regulations. Provides clinical and technical support for CRAs and administrative staff. Performs management of study site activities to ensure the integrity of clinical data in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs)
• Serves as main CTI contact for assigned investigative sites. Responsible for representation of CTI in a professional manner.
• Completes site selection and pre-study activities to identify and evaluate potential investigators. Assists in site evaluation and reports to Study Manager, as appropriate.
• Manages investigative site activity for multiple protocols/indications and provides ongoing updates of site status to study manager, ensuring compliance and understanding of study requirements by site staff.
• Assists with study start-up activities: collects, reviews and tracks regulatory site documents, assist in regulatory submission process to Ethic Committees and Competent Authority; and Contract and Budget negotiation.
• Participates in study-specific training and attends Investigator meetings.
• Completes monitoring visits and routing monitoring activities to ensure the integrity completeness and accuracy of clinical data and appropriate follow-up of study procedures, including source document verification and SAE reporting in accordance with the Project Plan, Study protocol, GCP/ICH Guidelines and applicable Regulations.
• Anticipates/identifies site issues and study deviations. Implements corrective actions and a proper escalation to Study Manager, as necessary
• Ensures proper storage, dispensation and accountability of all investigational product(s) and trial-related material
• Attend to global project team teleconferences and provides ongoing updates of site status to Study Manager. Maintain CTI/Sponsor project tracking systems, as required
• Complete assigned training programs in drug development processes, therapeutic areas, Good Clinical Practices (GCPs) and any applicable local regulatory requirements.
Reporting Line to CRA Manager
- Bachelor’s or Master’s Degree in allied health fields, such as Health/Natural sciences, Pharmacy, or Nursing.
- Research Nurse RN or study coordinator or 3-year Nursing Diploma with at least 2 years of clinical nursing experience
- At least 2 years of prior independent clinical monitoring experience plus CRA certification
- Knowledge in applicable regulatory requirements in Italy
- Proficient in the use of laptop computer and software systems (MS-Office package, eTMF, CTMS, etc)
- Excellent communication, presentation, interpersonal skills in English, are essential
- Reliability and a good sense of team working