Site Management Associate I

We are the company that cares – for our staff, for our clients, for our partners, and for the quality of the work we do.
A dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated, and passionate individuals.
We work on the frontline of medical science, changing lives and bringing new medicines to those who need them.
Job DescriptionJoin our international team and be the key support to clinical research projects, streamlining communication, maintaining systems, and managing documents & information.
Only CVs in English will be accepted. You will be responsible for: Being the main point of contact between site personnel and CRA involved in the project, helping with query resolution and EDC completion.Serving as the primary contact point for vendors, study supplies, and access management at the sites.Ensuring that pre-study testing (scans, MRI/CT qualification questionnaires, test ECGs, etc.)
of local site facilities is completed.Assisting monitors in their prompt completion of all subject and site event information in CTMS.
Tracking the resolution status of site issues and action items in CTMS.Ensuring the order, receipt, inventory storage, distribution, return/recall, and reconciliation of clinical supplies.Ensuring regulatory and ethics committee submissions and notifications, staying up-to-date on local regulations and dispositions.Coordinating preparation for and follow-up on site, TMF, and systems audits and inspections.Managing the TMF at the site and country level, filing documents, and preparing, distributing, and updating Investigator Site Files (ISF) and ISF checklists.Arranging and tracking initial and ongoing project training for site teams in all vendor-related systems.Reviewing document management and translation statuses of the study.Ensuring proper safety information flow with investigative sites.QualificationsCollege/University Degree in Life Sciences.Administrative work experience, preferably in an international setting.Prior experience working as a CTA for CROs.Prior experience working in Clinical Research.Knowledge of local regulations.Full working proficiency in English and Spanish.Proficiency in MS Office applications.Ability to plan and work in a dynamic team environment.Strong communication and collaboration skills.Additional InformationAdvance your career in clinical research by coordinating a variety of tasks and learning new skills while growing with the company.

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