Senior Clinical Research Associate (Senior CRA / SCRA) - Milan, Italy Nr ref.: /JOBS.pl Role: Senior Clinical Research Associate (Senior CRA / SCRA) Location: Milan Job Type: Permanent About Pharm-Olam International: With offices among the world's most populated cities, Pharm-Olam International provides cost effective coverage for full service or strategic outsourcing across all therapeutic areas and phases of research. Since 1994 we have used our local knowledge of an investigator's past performance, competing studies, and regulatory environment to offer sponsors an accurate and informed plan to complete trials on time. For more information about careers at Pharm-Olam please visit our careers page: Summary: To ensure that Investigators are conducting clinical trials in accordance with international regulatory and ethical guidelines for Good Clinical Practices (GCP) and International Conference on Harmonization (ICH). May be responsible for assisting the RA department in the preparation, compilation, submission and maintenance of regulatory documentation required by international regulatory agencies for clinical trials and marketing applications. Key Responsibilities: Provide functional assistance to the project team members with administrative, logistical and practical issues, including the tracking, collection, distribution and filing study documentation. Track and supervise collection of ongoing study data for purpose of regular project status reporting as required. Assist the Clinical Operations Manager in conducting feasibility assessment for potential studies. Govern minimum quality standards for trial monitoring activities, with respect to documentation, punctuality of reporting, compliance with objectives and co-operation with other project team members. Ensure adequate tracking is in place for all activities and reports formatted as required for submission within agreed timelines. Monitor activities at clinical study sites to assure adherence to GCP, ICH, SOPs and study protocols. Collect and review regulatory documents as required. Prepare site visit and telephone reports May participate in the study development and start-up process including reviewing protocols, drafting of the monitoring plan, designing and/or reviewing CRFs preparing informed consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. Participate in feasibility and/or site identification activities. May be assigned as LCRA to a regional or global study. May be required to manage the preparation of local clinical trial applications. Desired Skills and Experience: A minimum of 4 years experience in a similar role Fluent English & Italian, both written and verbal Strong therapeutic background Can demonstrate experience and knowledge in the CRO industry that will support Pharm-Olam's management of clinical trials Demonstrates the ability to define and meet project requirements. Proven organizational abilities, and excellent written and oral communication and presentation skills A thorough knowledge of regulatory submission and reporting requirements and guidelines Excellent understanding of the drug development process. **Please note that you must be eligible to live and work in Italy in order to apply for this position** Keywords: CRA, CRA I, CRA II, CRA III, Senior CRA, Clinical Research Associate, In-House CRA, Permanent CRA, Contract CRA, Freelance CRA, CRO, Clinical Research Organisation, Risk Based Monitoring, Late Phase, Early Phase, CTL, Clinical Team Leader, Project Manager, Junior Project Manager, EC Submissions, Clinical Research Manager, CRA Manager Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .
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