Clinical Trial Coordinator (CTC) - REMOTE

Remote, USA Full-time
About the position Responsibilities • Track essential documents and report safety reports • Ensure collation and distribution of study tools and documents • Update clinical trial databases (CTMS) and trackers • Manage clinical and non-clinical supply management in collaboration with other country roles • Coordinate labeling requirements and translation change requests • Prepare and manage clinical documents and correspondence • Assist with eTMF reconciliation and execute eTMF Quality Control Plan • Update manuals and documents such as patient diaries and instructions • Document proper destruction of clinical supplies • Collaborate with country roles for site evaluation and validation • Obtain and track study insurance certificates • Support preparation of submission packages for IRB/ERC and regulatory agencies • Publish study results as required by local legislation Requirements • Fluent in local languages and business proficient in English (verbal and written) • Good understanding of Global, Country/Regional Clinical Research Guidelines • Hands-on knowledge of Good Documentation Practices • Strong IT skills, including MS Office and clinical IT applications • Strong MS Excel skills • Knowledge of ICH-GCP appropriate to role • Excellent negotiation skills in finance area • Effective time management and organizational skills • Ability to handle multiple tasks in a changing environment • Ability to establish and maintain culturally sensitive working relationships • Proactive attitude to problem-solving Nice-to-haves • Bachelor's Degree preferred Benefits • Flexible work arrangements (remote) Apply tot his job
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