Site Management Associate I

hace 4 semanas

Buenos Aires, Buenos Aires C.F., Argentina Milestone One A tiempo completo

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 Description

Join 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 on query resolution and EDC completion.
  • Serving as the primary sites' contact point for vendors, study supplies, and access management.
  • Ensuring that pre-study testing (scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed.
  • Assisting the Monitors in their prompt completion of all subject event and site event information in CTMS. Tracking the resolution status of site issues and action items in CTMS.
  • Acting as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies.
  • Ensuring regulatory and ethics committee submissions and notifications, meaning you will need to be 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 on a site and a country level for regularly filing documents. 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.
  • Document Management and translations status review of the study.
  • Ensuring proper safety information flow with investigative sites.
Qualifications
  • College/University Degree in Life Sciences;
  • Administrative work experience, preferably in international settings;
  • Prior experience working as 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;
  • Communication and collaboration skills.
Additional Information

Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.

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