Clinical Trials Specialist

1 dia atrás

São Paulo, São Paulo, Brasil beBeeResearch Tempo inteiro US$42.000 - US$61.000
Job Overview

Clinical Research Associates play a vital role in ensuring the integrity and quality of clinical trials.

This position is ideal for highly motivated individuals seeking a challenging opportunity to contribute to the success of our team.

Key Responsibilities:
  • Act as primary contact for assigned sites for specific trials;
  • Participate in site feasibility and/or pre-trial site assessment visits;
  • Attend/participate in investigator meetings as needed;
  • Execute activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs)and policies;
  • Implement analytical risk-based monitoring model at the site level and work with site to ensure timely resolution of issues found during monitoring visits;
  • Ensure site staff are trained and corresponding training records are complete and accurate at any time point during all trial phases;
  • Contribute to site-level recruitment strategy and contingency planning and implementation in partnership with other functional areas;
  • Ensure site study supplies are adequate for trial conduct;
  • Arrange for appropriate destruction of clinical supplies;
  • Ensure accuracy, validity and completeness of data collected at trial sites;
  • Report Adverse Events /Serious Adverse Events/Product Quality Complaints within required reporting timelines and document accordingly;
  • Maintain complete, accurate and timely data and essential documents in relevant systems utilized for trial management;
  • Document trial-related activities, including monitoring, and write visit reports and follow-up letters in accordance with SOPs;
  • Review study files for completeness and ensure archiving retention requirements are met;
Requirements:
  • Bachelor's degree in Life Sciences, Nursing or related scientific field (or equivalent experience);
  • Specific therapeutic area experience may be required depending on the position;
  • Strong knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol-specific procedures including monitoring guidelines;
  • Strong IT skills in appropriate software and company systems;
  • Proficient in speaking and writing country language (Portuguese) and English;
  • Good written and oral communication skills;
  • Ability to travel with occasional overnight stays away from home;
Working Conditions:
  • Home-based position;
  • Occasional travel required.

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