EXCLUSIVE OPPORTUNITY FOR A CRA IN ITALY
Fed up of your current role? Looking for an exciting new role, offering great career progression and a wide range of benefits? This is a fantastic opportunity and the client can offer a very pleasant working atmosphere within an expert team of individuals, a role that allows this individual to see a direct impact on the growth of the company from their day to day work as well as a very competitive remuneration package.
My client , a global Clinical Research Organization our offering an exciting new opportunity as a Clinical Research Associate (CRA). You will be responsible for Monitoring all types of clinical trials ensuring adherence to Good Clinical Practices (GCP), investigator integrity and compliance with all study procedures. This role will change and expand your clinical research knowledge and is an exciting career development for those looking for a career step up.
Key responsibilities will include:
• Developing, implementing and maintaining study documents, timelines, report formats, files, communication tools, budgets, and systems used in conducting a project.
• Provide clear communication between levels of project: from team, to site and report to overall project leaders.
• Further provide project leader with communication assistance with sponsors and vendors.
• Maintain effective compliance with CFR, state regulations, ICH and GCP guidelines and INC research and sponsor SOP’s.
• Maintain current regulatory documentation according to Essential Regulatory Document Guidelines (ERDG) and Trial Master File (TMF) Plan.
• Participate in TMF and on-site audits as requested.
• Track and manage the distribution of study drug and clinical supplies as requested.
• Responsible for site management and site staff performance
• Assures effective patient identification and recruitment plan is in place.
• Assures expedient reporting of AEs/SAEs and Protocol Violations.
• Perform source data verification (SDV) and assure timely completion of CRFs according to Clinical Monitoring Plan (CMP) and / or Data Management Plan (DMP).
• Assure timely and accurate completion of Data Clarification Forms (DCFs).
• Performs clinical data listings reviews as needed.
• Maintain thorough report and tracking of site visits according to SOP.
• Provide a high level of administrative functions to assure smooth project running.
Requirements for this opportunity include:
• Bachelor degree in life sciences, pharmacy, registered nursing or equivalent
• A minimum of 1-3 years’ experience in research
• Previous monitoring or site management experience or equivalent in-house study management experience an asset
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Strong communication skills with the ability to build strong internal and external relationships
For a chance to speak to this company or for more information please email me directly at firstname.lastname@example.org with your contact number and latest CV. Your CV will not be forwarded prior to speaking with you. Be aware, there is very limited time to apply as this position is closing soon!