Senior CRA II – Site Care Partner – Sponsor Dedicated

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

📋 Description

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

• Utilizes judgment and experience to assess the overall performance of the site and its staff, providing recommendations for site-specific actions; promptly communicates and escalates critical issues to the project team while developing action plans.

• Maintains up-to-date knowledge of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.

• Ensures that the process of obtaining informed consent has been properly conducted and documented for each subject/patient as needed.

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

• Evaluates factors that may impact the safety of subjects/patients and the integrity of clinical data at investigator/physician sites, such as protocol deviations/violations and pharmacovigilance concerns.

• Performs Source Document Review of relevant site documents and medical records, verifying that the clinical data recorded in the case report form (CRF) is accurate and complete through examination of site documents and medical records.

• Implements query resolution techniques both remotely and on-site, offering guidance to site staff as needed, while driving query resolution to completion within agreed timelines.

⛳️ Requirements

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

• A minimum of 5-7 years of experience in clinical research monitoring, specifically in Oncology.

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

• Strong computer skills and a willingness to adopt new technologies.

• Excellent communication, presentation, and interpersonal skills.

• A moderate level of critical thinking skills is required.

• Capacity to manage travel requirements of up to 75% regularly.

🏝️ Benefits

• We are committed to the growth of our employees through career development and advancement opportunities;

• Supportive and engaged line management;

• Technical and therapeutic area training;

• Peer recognition and comprehensive rewards program.