SITE MANAGEMENT ASSOCIATE I

<p>Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents &amp; information.&#xa0;</p><p><strong><u>Only CVs in English will be accepted.</u></strong></p><p><strong>You will be responsible for:</strong></p><ul><li>Being the main point of contact between site personnel and CRA involved in the project helping on query resolution and EDC completion.</li><li>Serves as the primary sites’ contact point for vendors, study supplies, and access management.</li><li>Ensure that pre-study testing (scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed.&#xa0;</li><li>Assists the Monitors in their prompt completion of all subject event and site event information in CTMS. Track the resolution status of site issues and action items in CTMS.</li><li>Act as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies.</li><li>Ensures regulatory and ethics committee submissions and notifications, meaning you will need to be up to date on local regulations and dispositions.</li><li>Coordinate preparation for and follow-up on site, TMF and systems´ audits and inspections.</li><li>Manage the TMF on a site and a country level for regularly and file&#xa0;documents. Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists.</li><li>Arrange and track initial and on-going project training for site teams in all vendor-related systems.</li><li>Document Management and translations status review of the study.</li><li>Ensures proper safety information flow with investigative sites.</li></ul><p>&#xa0;</p> <ul><li>College/University Degree in Life Sciences;&#xa0;</li><li>Administrative work experience, preferably in an international settings;</li><li>Prior experience working as CTA for CROs;</li><li>Prior experience working in Clinical Research;&#xa0;</li><li>Local regulations knowledge;</li><li>Full working proficiency in English;&#xa0;</li><li>Proficiency in MS Office applications;</li><li>Ability to plan&#xa0;and work in a dynamic team environment;</li><li>Communication and collaboration skills.</li></ul> <p>Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.</p>