ph3CRA II/ Senior CRA I
- Future Roles (Italy) /h3pSyneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®. /ppDiscover what our 29,000 employees, across 110 countries already know. WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. /ph3Job Responsibilities /h3ulliPerforms site qualification, site initiation, interim monitoring, site management activities and close‑out visits (performed on‑site or remotely) ensuring regulatory, ICH‑GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.



/liliUses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. /liliMaintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. /liliVerifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. /liliDemonstrates diligence in protecting the confidentiality of each subject/patient. /liliAssesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. /liliPer the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. /liliConducts Source Document Review of appropriate site source documents and medical records. /liliVerifies required clinical data entered in the case report form (CRF) is accurate and complete. /liliApplies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. /liliUtilizes available hardware and software to support the effective conduct of the clinical study data review and capture. /liliVerifies site compliance with electronic data capture requirements. /liliMay perform investigational product (IP) inventory,



reconciliation and reviews storage and security. /liliVerifies the IP has been dispensed and administered to subjects/patients according to the protocol. /liliVerifies issues or risks associated with blinded or randomized information related to IP. /liliApplies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. /liliRoutinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. /liliReconciles contents of the ISF with the Trial Master File (TMF). /liliEnsures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. /liliDocuments activities via confirmation letters, follow‑up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. /liliSupports subject/patient recruitment, retention and awareness strategies. /liliEnters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. /liliFor assigned activities, understands project scope, budgets, and timelines; manages site‑level activities / communication to ensure project objectives, deliverables and timelines are met. /liliMust be able to quickly adapt to changing priorities to achieve goals / targets. /liliMay act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. /liliEnsures all assigned sites and project‑specific site team members are trained and compliant with applicable requirements Prepares for and attends Investigator Meetings and/or sponsor face to face meeting

📌 CRA II/ Senior CRA I (Italia)
🏢 3013 Syneos Health Italy
📍 Italia