Site Management Associate I

Psicro

Buenos Aires

On-site

ARS 900,000 - 1,300,000

Full time

3 days ago
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Job summary

Psicro is seeking an organized administrator to support clinical research projects from our Buenos Aires site. You will liaise between site personnel and CRAs, assist with EDC completion, and manage CTMS data and document flow.

The role requires strong English, regulatory knowledge, and experience in CRO/clinical research. You will coordinate supplier tasks, site audits, and training across systems.

Qualifications

  • College/University Degree in Life Sciences is required.
  • Experience in international settings is preferred.
  • Experience as a CTA for CROs.
  • Experience in Clinical Research.
  • Knowledge of local regulations.
  • Strong English proficiency.
  • Proficiency with MS Office applications.
  • Ability to plan and work in a dynamic team environment.
  • Strong communication and collaboration skills.

Responsibilities

  • Main contact between site personnel and CRA, assisting query resolution and EDC completion.
  • Primary site contact for vendors, study supplies, and access management.
  • Ensure pre-study testing of local site facilities is completed.
  • Assist Monitors with CTMS data entry and track site issues.
  • Manage ordering, receipt, storage, distribution and recalls of clinical supplies.
  • Ensure regulatory and ethics submissions and notifications are up to date.
  • Coordinate audits and inspections for site, TMF and systems.
  • Manage TMF at site and country level; prepare ISF and ISF checklists.
  • Arrange and track site training for vendor-related systems.
  • Review document management and translations status.
  • Ensure proper safety information flow with investigative sites.

Skills

Administrative work experience
CTA experience for CROs
Clinical Research experience
Local regulations knowledge
English proficiency
Plan and work in dynamic team
Communication and collaboration skills

Education

Life Sciences degree

Tools

MS Office applications

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;
  • Proficiency in MS Office applications;
  • Ability to plan and work in a dynamic team environment;
  • Communication and collaboration skills.

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

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