A growing CRO that specialises in rare/orphan disease and oncology, is looking to recruit a CRA II to be based at their offices in Italy.
- Administration and full investigator site responsibility for clinical studies according to company Standard Operating Procedures (SOPs), ICH-GCP and local regulations
- Ensures clinical trials are monitored such that subjects' rights, safety and well being are protected and that the clinical trial data are reliable.
- Acts as a member of the project team with the goal to contribute towards efficient management of trials;
- Negotiates investigator budgets and assists with the execution of site contracts with support from the legal department;
- Involved in recruitment of potential Investigators, preparation of Independent Ethics Committee/Independent Regulatory Board (IEC/IRB) submissions, notifications to regulatory authorities, translation of study related documentation, organisation of meetings and other tasks as instructed by the PM;
- Oversees all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good Quality Assurance reports;
- Establishes, updates, tracks and maintains study specific trial management tools/systems, and status reports;
- Performs pre study visits: discusses protocol, other available study documentation and study requirements with Investigator and other trial staff, ensures that trial staff and site facilities and the site's recruitment potential are in accordance with protocol requirements, local regulations, ICH-GCP and Company SOPs
- Performs monitoring visits: ensures adherence to protocol, accurate data collection via comprehensive source document verification, and investigational product/biological samples/supplies accountability;
- Communicates effectively with site personnel, including the Principal Investigator (PI), and company management to relay protocol/study deviations and ensure timely implementation of corrective actions;
- Develops and maintains strong working relationship with Investigators and study staff, serving as an ambassador to promote company high quality and ethical image;
- Understands and updates Clinical Trial Management System (CTMS) in a timely manner;
- Monitors and updates data in an Electronic Data Capture (EDC) system in a timely manner and in accordance with study specific guidelines;
- Performs data management review, including in-house CRF review, and alerts project managers and data managers to emerging issues with CRF completion;
- Identifies and processes Serious Adverse Events (SAEs) according to the procedures defined by the study team;
- Demonstrates a broad understanding of the SAE reporting process to regulatory authorities;
- Liaises with data management to resolve data discrepancies and ensure all data management study goals are met;
- Prepares and performs closeout visits according to the protocol, local laws, ICH-GCP and company SOPs;
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please send your CV to Francesca D'Arpa on f.d'[click here]
A full job description is available on request.
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