Sr CRA in Brazil, Indiana at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Sr CRA in Brazil.

This role is centered on ensuring the quality, compliance, and integrity of clinical trial operations across assigned investigative sites. The professional will act as a key liaison between study teams and clinical sites, supporting the full study lifecycle from initiation through close-out. Working remotely with regular travel, the role requires strong expertise in site monitoring, regulatory compliance, and GCP standards. You will be responsible for ensuring that clinical data is accurate, complete, and compliant with study protocols and applicable regulations. The position operates within a highly collaborative and global environment, supporting innovative clinical research programs that directly contribute to advancing patient care. It is a critical role for maintaining study quality and ensuring operational excellence across clinical sites.

• Conduct site qualification, initiation, monitoring (on-site or remote), and close-out visits in compliance with ICH-GCP, SOPs, and study protocols.
• Verify informed consent processes, patient safety documentation, and adherence to regulatory requirements at clinical sites.
• Perform source document verification, CRF data review, and query resolution to ensure data accuracy and integrity.
• Assess site performance, identify deviations or risks, and escalate critical issues to project teams with recommended corrective actions.
• Support investigational product (IP) management, including accountability, storage, dispensing, and reconciliation when applicable.
• Review Investigator Site Files (ISF) and ensure alignment with Trial Master File (TMF) requirements.
• Document monitoring activities through reports, communication logs, and tracking systems in accordance with SOPs.
• Support patient recruitment, retention initiatives, and site engagement activities.
• Participate in investigator meetings, training sessions, audits readiness activities, and operational planning.
• May provide mentorship and guidance to junior CRAs and contribute to process improvements and site efficiency initiatives.

• Bachelor’s degree in a health-related field or equivalent combination of education and clinical research experience (RN or equivalent accepted).
• Strong knowledge of ICH-GCP guidelines and applicable regulatory frameworks.
• Proven experience in clinical site monitoring and clinical trial operations.
• Ability to perform source data verification, data review, and query resolution effectively.
• Familiarity with clinical trial systems, EDC platforms, and digital monitoring tools.
• Strong communication, interpersonal, and presentation skills for interaction with site personnel and study teams.
• Analytical thinking and ability to identify risks, deviations, and operational improvements.
• Willingness and ability to travel up to 75% as required.
• Proactive, detail-oriented, and capable of working in fast-paced, global research environments.

• Competitive compensation aligned with experience and market standards.
• Remote-based work with extensive field flexibility and travel opportunities.
• Exposure to global clinical research programs and innovative therapeutic areas.
• Career development, training, and progression opportunities in clinical operations.
• Inclusive and collaborative work culture focused on professional growth.
• Participation in high-impact studies contributing to advancements in healthcare.