Remote Otter LogoRemoteOtter

Site Management Associate I - Remote

Posted 3 days ago
All others
Full Time
Romania

Overview

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

In Short

  • Exchanges data, documents and other project relevant information between investigative sites, site vendors and the project team.
  • Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies.
  • Ensures proper administration of sites and vendors payments, as applicable.
  • Ensures regulatory and ethics committee submissions and notifications.
  • Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections.
  • Supports the organization of internal team meetings including preparation of agendas and minutes, and also of Investigator’s Meetings.
  • Maintains study-specific and corporate tracking systems.
  • Maintains Trial Master File (TMF) and performs TMF review and oversight at country and site level.
  • Prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists.
  • Ensures proper safety information flow with investigative sites.

Requirements

  • College/University Degree (preferably Life Sciences).
  • Proficiency in standard MS Office applications.
  • Proficiency in English.
  • Good organizational and planning skills, problem-solving abilities, and flexibility.
  • Detail-oriented, able to multi-task and work effectively in a fast-paced environment.
  • Team-oriented with excellent customer service and interpersonal skills.

Benefits

  • Focus on professional development and success.
  • Easy and straightforward recruitment process.
  • Guidance and support throughout the recruitment experience.
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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