Senior Clinical Research Professional

Há 2 dias

São Paulo, São Paulo, Brasil beBeeClinicalResearchAssociate Tempo inteiro US$80.000 - US$100.000
Clinical Research Associate (CRA)

The primary responsibility of a Clinical Research Associate (CRA) is to oversee clinical trials and ensure they are conducted in accordance with Good Clinical Practice (GCP) guidelines.

About the Role

We are seeking an experienced and detail-oriented CRA to join our team. The successful candidate will be responsible for:

  • Selecting, initiating, and managing clinical investigational sites from start-up to close-out.
  • Conducting pre-study, initiation, monitoring, and closeout visits in accordance with ICON SOPs and GCP guidelines.
  • Ensuring compliance with study protocols and applicable regulations.
  • Maintaining and updating clinical systems to ensure accuracy and timeliness of data.
  • Supporting patient recruitment by collaborating closely with investigators and motivating sites.
  • Managing regulatory documentation, including ethics/IRB submissions and approvals.
  • Overseeing investigational product (IP) accountability, storage, and compliance at the site level.
  • Addressing and resolving site and sponsor-generated queries in a timely manner.
  • Maintaining thorough study files and ensuring proper archiving upon study completion.
  • Providing regular updates to the Project Manager and contributing to study progress reports.
Requirements

To be successful in this role, you will need:

  • A strong working knowledge of ICH-GCP, clinical trial regulations, and ICON SOPs.
  • Prior experience as a CRA or equivalent role in clinical monitoring.
  • Familiarity with clinical trial systems and site management processes.
  • Excellent organizational and communication skills.
  • An independent, proactive, and solution-oriented approach to work.
  • The ability to travel up to 60% (domestic and international).
What We Offer

At our organization, we value our people and their contributions. We foster a culture of performance, innovation, and collaboration. In return for your expertise and dedication, we offer a competitive compensation package and opportunities for professional growth and development.

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