Clinical Research Associate

Há 3 dias

Brasil beBeeClinicalResearchAssociate Tempo inteiro R$90.000 - R$120.000
Job Summary">

A Clinical Research Associate plays a vital role in advancing drug/device/outcomes research by independently monitoring studies to ensure patient safety and data integrity. In this position, you will join a collaborative program that employs an extensive co-monitoring approach, fostering a supportive work environment.

The ideal candidate will be responsible for monitoring the progress of clinical studies at investigative sites or remotely, ensuring trials are conducted, recorded, and reported in accordance with protocols, standard operating procedures (SOPs), International Conference on Harmonization Good Clinical Practices (ICH-GCP) and relevant regulatory requirements.

  • Qualify potential investigative sites, initiate clinical trials, maintain study files, provide instructions to site personnel, and perform study close-out activities.
  • Verify the protection of study participants by confirming informed consent procedures and protocol adherence to applicable regulations.

Additionally, the Clinical Research Associate ensures the integrity of clinical data and compliance with approved protocols, GCP, applicable regulations, and SOPs. They manage investigational site staff to facilitate trial deliverables, verify proper IP management, write and submit reports of investigational site findings, and escalate observed deficiencies, issues, and corrective actions as necessary.

  • Manage essential documents according to local regulations and ICH-GCP guidelines, assist with resolution of investigational site/data queries, perform key risk assessments, and participate in audit preparation and follow-up activities.
  • Independently conduct various onsite and offsite monitoring visit types, gather and review information for assigned sites, identify inconsistencies, assess risk, and escalate as appropriate.
Required Skills and Qualifications">

To excel in this role, you should possess:

  • An undergraduate degree or international equivalent in a clinical, science, or health-related field from an accredited institution.
  • Healthcare professional licensure, i.e., registered nurse.
  • Previous experience supporting clinical trials, including solid onsite monitoring experience.
  • Fluency in English and host country language.
Benefits">

At our organization, we prioritize employee development in a continuous learning culture. We offer:

  • Engaging work that challenges you professionally.
  • A comprehensive total reward package comprising base pay, variable pay, and recognition programs.
  • Best-in-class employee benefits, supportive policies, and wellbeing initiatives tailored to support your career growth.

We are an equal opportunity and inclusive employer committed to providing a workplace free of discrimination and harassment. All qualified applicants receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

If you require reasonable accommodation for any part of the application process or to perform the essential functions of this position, please let us know.

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