Clinical Research Associate

4 semanas atrás

Brasil Pharmaceutical Research Associates, Inc Tempo inteiro
Overview

A Clinical Research Associate is a professional who contributes to accelerated drug/device/outcomes research through independent monitoring of studies to ensure patient safety and data integrity.

You will join a program that takes an extensive co-monitoring approach, enabling a supportive and collaborative work environment. Frequent, consistent communication, both internally and with our client, helps our program stay aligned on shared goals.

Responsibilities

The Clinical Research Associate (CRA) monitors the progress of clinical studies at investigative sites or remotely, ensuring trials are conducted, recorded, and reported in accordance with the protocol, SOPs, ICH-GCP, and all applicable regulatory requirements.

  • Complete onsite and remote monitoring activities in line with ICH-GCP guidelines, regulations, SOPs, and study processes, including qualifying sites, initiating trials, maintaining files, instructing site personnel, and study close-out.
  • Verify protection of study participants by confirming informed consent procedures and protocol adherence.
  • Ensure data integrity and compliance with the protocol, GCP, regulations, and SOPs.
  • Manage investigative site staff to facilitate trial deliverables such as subject enrollment and data submission.
  • Verify proper management and accountability of Investigational Product (IP).
  • Write and submit reports of site findings and update tracking systems; escalate issues as needed.
  • Manage essential documents per regulations and ICH-GCP guidelines before, during, and after studies; assist with data queries.
  • Perform risk assessments, site health analysis, process evaluation, and project escalation.
  • Participate in audit preparation and follow-up activities.


• Perform various onsite and offsite monitoring visits independently.


• Review site information, identify inconsistencies, assess risks, and escalate issues appropriately.


• Support additional studies or departmental initiatives through adhoc assignments.


• Potentially serve as a preceptor, training less experienced team members.

Qualifications
  • Undergraduate degree or equivalent in clinical, science, or health-related field; healthcare professional licensure (e.g., registered nurse).
  • Previous clinical trial support experience, including solid on-site monitoring.
  • Based in São Paulo or Porto Alegre.
  • Travel required 50-80%.
  • Equivalent education, training, and relevant experience may be considered.
  • Fluent in English and host country language (reading, writing, speaking).
Benefits

At ICON, we are committed to employee development within a continuous learning culture. We offer a competitive total rewards package, including base pay, variable pay, recognition programs, and comprehensive benefits. Our policies and wellbeing initiatives support you and your family throughout your career.

ICON is an equal opportunity employer, committed to a workplace free of discrimination and harassment. Qualified applicants will receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. If you need a reasonable accommodation during the application or employment process, please let us know.

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