Senior Clinical Research Coordinator

2 semanas atrás

São Paulo, São Paulo, Brasil beBeeClinicalResearch Tempo inteiro R$90.000 - R$123.000
Job Overview

The role of Senior Study Start up Specialist involves performing tasks at a country level related to Site Activation activities in accordance with local and international regulations, standard operating procedures, project requirements, and guidelines.

Responsibilities
  • Serve as Single Point of Contact for investigative sites, Site Activation Manager, Project Management team, and other departments ensuring adherence to standard operating procedures, Work Instructions, quality of designated deliverables, and project timelines.
  • Perform start-up and site activation activities according to applicable regulations, SOPs, and work instructions, distributing completed documents to sites and internal project team members.
  • Prepare site regulatory documents reviewing for completeness and accuracy.
  • Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.
  • Review and provide feedback on site performance metrics.
  • Review, establish, and agree on project planning and project timelines, implementing contingency plans as needed.
  • Inform team members of the completion of regulatory and contractual documents for individual sites.
  • Review, track, and follow up the progress, approval, and execution of documents, regulatory, ethics, Informed Consent Form, and Investigator Pack release documents in line with project timelines.
  • Provide local expertise to SAMs and project teams during initial and ongoing project timeline planning.
  • Perform quality control of documents provided by sites.
  • Maintain direct contact with sponsors on specific initiatives.
Qualifications
  • Bachelor's Degree in life sciences or a related field and 3 years' clinical research experience or equivalent combination of education, training, and experience.
  • 3 years clinical research experience including 1 year experience in a leadership capacity.
  • In-depth knowledge of clinical systems, procedures, and corporate standards.
  • Good negotiating and communication skills with ability to challenge.
  • Effective communication, organizational, and interpersonal skills.
  • Ability to work independently and effectively prioritize tasks.
  • Ability to manage multiple projects.
  • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
  • Knowledge of applicable regulatory requirements including local regulations, SOPs, and company Corporate Standards.
  • Understanding of regulated clinical trial environment and knowledge of drug development process.
  • Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
About the Role

This is an exciting opportunity to join a leading global provider of clinical research services, commercial insights, and healthcare intelligence. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to improve patient outcomes and population health worldwide.

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