Remote Otter LogoRemoteOtter

Site Management Associate I - Remote

Posted 15 weeks ago
All others
Full Time
Colombia

Overview

Join our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information.

In Short

  • 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 of local site facilities is completed
  • Assists the Monitors in their prompt completion of all subject event and site event information 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
  • Coordinate preparation for and follow-up on site, TMF and systems´ audits and inspections
  • Manage the TMF on a site and a country level regularly and file documents
  • 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

Requirements

  • 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

Benefits

  • Advance your career in clinical research
  • Coordinating a variety of tasks
  • Learning new things while growing with the company
PSI CRO logo

PSI CRO

PSI CRO is a prominent Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. Founded in Switzerland, PSI is a privately owned, full-service CRO that operates globally, supporting clinical trials across various countries and continents. The company is known for its selective approach to project engagement, emphasizing high-quality and timely services across a wide range of therapeutic areas. PSI values diversity and inclusivity within its workforce, fostering an environment where all colleagues feel welcomed and valued. The organization is dedicated to not only conducting clinical trials but also building a community that empowers team members to thrive and contribute to significant advancements in the pharmaceutical sector.

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