Clinical Research Associate II

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

📋 Description

• Execute and oversee clinical monitoring tasks in alignment with GCPs, SOPs, ICH-GCP guidelines, and local regulations.

• Perform site visits such as PSSV, SIV, IMV, and COV.

• Act as the site manager, fostering relationships and communication with site staff.

• Ensure data quality and patient safety through monitoring and site education.

• Evaluate the safety and efficacy of investigational products and/or medical devices.

• Assess compliance with protocols and regulations, and prepare necessary documentation.

• Cultivate collaborative partnerships with investigative sites and study vendors.

• Deliver training on protocols, studies, and project teams.

• Monitor enrollment, CRF data entry, protocol deviations, and site-related issues.

• Guide and mentor less experienced CRAs.

• Relay site performance information to the Clinical Study Team.

• Conduct SAE reconciliation and address discrepancies with study sites.

• Partner with the CST and clinical study sites to achieve study milestones.

• Participate in regional investigator meetings and site booster visits as necessary.

• Assist in audit and inspection preparations, and follow through on quality issues until resolved.

• Manage site-level activities for established protocols and portfolios.

• Collaborate with CRAs for co-monitoring and support site visits as required.

⛳️ Requirements

• Bachelor’s or Master’s degree in a relevant scientific field.

• At least 2 years of relevant Clinical Operations experience.

• Minimum of 1 year of monitoring experience.

• Knowledge of clinical trial processes and a comprehensive understanding of ICH and related regulatory guidelines.

• Proficient in English, both written and spoken.

• Proficiency in Spanish is advantageous.

• Preferred experience in global oncology trials.

• Strong communication and interpersonal abilities.

• Exceptional organizational skills with the capacity to prioritize and manage multiple tasks.

• Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.

• Familiarity with industry CTMS and data management systems.

• Preparedness and willingness to travel up to 70% of the time.

🏝️ Benefits

• Equal opportunity employer.

• Up to 70% travel associated with the role.