Clinical Trial Assistant
2 days ago
Caen
1MED SA, Contract Research Organization that provides clinical and regulatory services to medical device, in vitro diagnostic, pharmaceutical companies is hiring. We are looking for a Clinical Trial Associate with a minimum of 3 (preferred: 5 years) of experience to join our team. The Clinical Trial Associate (CTA) will provide essential support to the Clinical Operations team in the planning, execution, and oversight of medical device clinical investigations. The CTA ensures that all documentation and systems are maintained in compliance with ISO 14155, EU MDR (2017/745), FDA 21 CFR Part 812, and internal SOPs. This role requires strong organizational skills, attention to detail, and the ability to coordinate across multiple stakeholders and projects. Key responsibilities (not limiting) • Support site start-up activities by tracking and reviewing regulatory and essential documents (e.g., CVs, licenses, contracts), • Support the drafting of documents such as the Protocol, Informed Consent and Case Report Form (CRF)., • Support preparation of submissions to competent authorities (Ethics Committees, Ministry of Health, etc.) and help drive activities related to study activation readiness., • Preparation and updating of the Trial Master File., • Preparation of the Investigator Site File to be sent to the centers involved in the study., • Prepare and distribute meeting agendas and minutes for project team meetings., • Coordinate site and CRA logistics, ensuring monitoring visit support materials are prepared in advance., • Support data entry and updates across CTMS, EDC, and eTMF systems., • Participate in ongoing training to maintain and enhance role competencies., • Conduct co-monitoring activities at the study centers and drafting of the relative reports, • Report major protocol, GCP and SOP violations to the Clinical Project Manager Education: • Preferred Bachelor’s degree in Life Sciences, Nursing, or related field., • Knowledge of GCP (ISO 14155), MDR, and ICH E6(R2)., • Strong IT skills, including MS Office and clinical trial platforms. Location: • Caen, France Skills and personality: • Previous experience in clinical research (CRO, sponsor, or site environment), preferably in medical devices., • Experience in document management and TMF maintenance., • Excellent communication and coordination skills across cross-functional teams., • Attention to detail and high standards of quality control., • Proficiency with clinical systems (CTMS, EDC, eTMF)., • Ability to manage multiple tasks and timelines effectively., • Strong ethical standards, confidentiality, and patient-safety awareness. Please send your application to
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