Clinical trial monitoring associate

3 settimane fa

Roma, Lazio, Italia Nouscom A tempo pieno

Nouscom is a private clinical stage immuno-oncology company developing next-generation, off-the-shelf and personalized cancer vaccines. Our proprietary viral vector platform has the capacity to encode for large payloads of neoantigens or other immunomodulators and is clinically demonstrated to safely and potently harness the power of the immune system. We are looking for a Clinical Trial Monitoring Associate (CTMA) to work in collaboration with the CTL/CTM and contributes to the conduct of the trial(s) in compliance with ICH-GCP and applicable regulations: Assist in preparing, conduct and follow-up of team, investigator, kick-off and scientific meetings, including meeting minutes Coordinates, oversees and tracks clinical supplies, biological samples, investigational product, questionnaires, etc. Trial status and trial team tracking and reporting Update of clinical trial registries May participate in co-monitoring visits to study sites Review of Monitoring Visit Reports May assist in review of study documents and presentations Manage and oversee vendors Management of investigator and vendor invoices Set-up, maintenance and quality check of e TMF Support set-up of relevant systems for clinical trials such as EDC, IRT, e TMF, RACT, etc. Maintains good working relationship and communication across departments to ensure efficient management of study activities. Keeps abreast of updates on ICH-GCP, SOPs, guidelines and regulatory requirements for conduct of clinical trials Engage in team meetings, contribute ideas, and gain exposure to cross-functional collaboration within the work environment. Respond to ad hock requests from stakeholders Other duties as assigned Purpose of the Position The CTMA supports the Clinical Trial Team in all aspects of operational activities on phase I-IV clinical trial(s) from planning till close-out. Job requirements: Education: Bachelor's degree or equivalent qualification in Life Science/Healthcare Professional Experience 2 years of clinical research experience Competencies & Personal Skills: Good communication, organization and tracking skills Good knowledge of Good Clinical Practice Familiar with drug development and clinical trial process Ability to work in a matrix organization Demonstrate collaboration skills Ability to work under pressure Effectively prioritizes workload Fluent English (spoken and written) As part of a small high growth business you will get the opportunity to be involved in many different areas and our rapid growth trajectory means you will have the opportunity to grow with us. Nouscom is an equal opportunity employer. We welcome applications from all individuals. We are committed to treating all applicants fairly and avoiding discrimination.

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