Clinical Research Associate Senior
DOCS
Buenos Aires, Argentina
hace 5 días
source : JobLeads

We're looking for a candidate to fill this position in an exciting company.

  • Facilitate subject enrolment at the site level with focused patient recruitment strategies and action plans;
  • Identify site needs and site-related issues, escalate and / or initiate corrective actions when necessary, providing solutions for site staff to facilitate the clinical trial process;
  • Respond to site-related queries and escalate site-related issues with operational site management responsibility;
  • Perform investigational product accountability and reconciliation, maintain site study supplies, and facilitate the resolution of clinical queries to investigative staff;
  • Build and maintain solid and long-term professional relationships with investigators and site staff;
  • Ensure clinical study sites are conducting clinical trials in compliance with the respective protocol, our client's SOPs and applicable ICH / GCP guidelines and regulations;
  • Assist in preparing sites for audits, review audit reports and contribute to resolving findings;
  • Implement new technologies and systems at clinical sites, e.g. EDC systems;
  • Ensure appropriate safety reporting as well as tracking and reporting of adverse events (AEs and SAEs) and to verify case reports and source documentation;
  • Input and maintain electronic site management systems, provide input into clinical monitoring plans, input into case report forms and study-related documents as requested.
  • Strong phase II / III commercial clinical monitoring experience with willingness to travel nation-wide.
  • Excellent communication and time management skills to manage multiple projects at any one time.
  • Being a strong team member who understands the need for effective communication at all levels.
  • Ability to demonstrate effective relationship building with sponsors, sites and colleagues, as well as strong management skills
  • Life science degree and clean full driving licence
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