Clinical Research Associate II - Multi-Sponsor

## About the Role When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel is pleased to announce we are looking to hire several CRA II for the team in Italy. Candidates must have close to at least 2 years independent monitoring experience in a similar setting. The role can be based in any major Italian city as strong transport links are required for national travel. ## Responsibilities - The Clinical Research Associate is the clinical sites’ direct point of contact and accountable for managing site quality and delivery from site identification through close-out. - Build the relationship with the site, be the sole position accountable for the site performance, including driving the site successfully to initiation, the development of a robust patient recruitment strategy, setting up a system, assessing compliance with regulations and the site’s capability to comply with the study needs and recruitment expectations, and problem solving to address and resolve site issues. - Oversee the conduct of the trial at designated sites, ensuring the rights and well-being of human subjects are protected, evaluating the quality and integrity of the reported data, evaluating the site efficacy of staff training and requiring retraining where necessary, developing strategy regarding patient recruitment, evaluating and building the relationship with the clinical site, using problem-solving to promote positive working relationships with the site and staff, and ensuring the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP and with the applicable regulatory requirement(s). - Maintenance (from initiation through close-out): Act as PAREXEL’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites, and perform problem-solving to address and resolve site issues. - Build relationships with investigators and site staff. - Facilitate and support site with access to relevant study systems and ensure sites are compliant with project specific training requirements. - Evaluate if on-site staff assignment is still accurate and determine and implement corrective actions & follow-up, if necessary / relevant. - Address and resolve issues at sites, including the need for additional training. ## Requirements - Candidates must have close to at least 2 years independent monitoring experience in a similar setting. - The role can be based in any major Italian city as strong transport links are required for national travel. ## Nice to Have - Not specified in the provided text. ## Benefits - Not specified in the provided text.