CRA – Experience in Regulatory and Monitoring

This is a fully remote position, open to applicants in Brazil.

📋 Description

• Conducts site qualification, initiation, interim monitoring, management activities, and close-out visits (either on-site or remotely) while ensuring adherence to regulatory standards, ICH-GCP, Good Pharmacoepidemiological Practices (GPP), and protocol compliance.

• Utilizes judgment and experience to assess the overall performance of the site and its staff, offering recommendations for site-specific actions; escalates serious issues to the project team promptly and collaborates on developing action plans.

• Maintains a comprehensive understanding of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.

• Confirms that the process of obtaining informed consent has been effectively executed and documented for each subject/patient, as required or appropriate.

• Shows diligence in safeguarding the confidentiality of each subject/patient.

• Evaluates factors that could impact the safety of subjects/patients and the integrity of clinical data at an investigator/physician site, including protocol deviations/violations and pharmacovigilance issues.

• Conducts Source Document Review of relevant site source documents and medical records.

• Ensures that the clinical data entered in the case report form (CRF) is accurate and complete.

• Implements query resolution techniques both remotely and on-site, providing guidance to site staff as necessary, and ensuring query resolution is completed within agreed timelines.

• Leverages available hardware and software to facilitate effective data review and capture for clinical projects.

• Ensures that the investigator/physician site understands the requirements for archiving essential documents in compliance with local guidelines and regulations.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field, or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory standards.

• Proficient computer skills and an ability to adapt to new technologies.

• Exceptional communication, presentation, and interpersonal skills.

• Willingness to manage required travel of up to 75% on a regular basis.

🏝️ Benefits

• We are dedicated to the development of our people through career advancement and growth opportunities.

• Supportive and engaged line management.

• Technical and therapeutic area training provided.

• Peer recognition and a comprehensive total rewards program.

• We are committed to fostering an inclusive culture where you can truly be yourself.