Site Management Associate I

hace 1 mes

Buenos Aires, Argentina PSI CRO A tiempo completo
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.
  • Serves as the primary sites’ contact point for vendors, study supplies, and
  • access management.
  • Ensure that pre-study testing (scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed
  • 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.
  • Act as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies.
  • Ensures regulatory and ethics committee submissions and notifications, meaning you will need to be up to date on local regulations and dispositions.
  • Coordinate preparation for and follow-up on site, TMF and systems´ audits and inspections.
  • Manage the TMF on a site and a country level for regularly and file documents. Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists.
  • Arrange and track initial and on-going project training for site teams in all vendor-related systems.
  •  Document Management and translations status review of the study.
  • Ensures proper safety information flow with investigative sites.

 


Qualifications

  • College/University Degree in Life Sciences; 
  • Administrative work experience, preferably in an international settings;
  • Prior experience working as CTA for CROs;
  • Prior experience working in Clinical Research; 
  • Local regulations knowledge;
  • 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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