Clinical Research Associate II

Clinical Research Associate II

This role offers the opportunity to contribute directly to the successful delivery of clinical trials in a remote position based in Brazil. You will act as a primary Clinical Research Associate, taking ownership of site management and clinical monitoring activities. The role combines site visits, regulatory and protocol compliance, data quality oversight, and patient safety monitoring. You will build strong relationships with investigators and site teams while serving as a key communication link with the broader Clinical Study Team. You will also contribute to study milestones, site education, audit readiness, and the resolution of clinical and data-quality issues. The position offers exposure to global clinical research, with particular relevance to pharmaceutical, biotechnology, hematology, and oncology studies. This is a highly collaborative role suited to an organized clinical research professional who is comfortable working independently and traveling extensively.

Accountabilities

• Perform and coordinate assigned clinical monitoring activities in accordance with ICH-GCP guidelines, applicable regulations, and internal SOPs.
• Conduct site visits, including pre-study site visits, site initiation visits, interim monitoring visits, and close-out visits.
• Act as the primary site manager, maintaining effective communication and collaborative relationships with investigators and key site personnel.
• Assess protocol compliance, regulatory adherence, patient safety, and data quality during monitoring activities.
• Prepare accurate and timely monitoring reports and other required clinical documentation.
• Provide protocol, study, and related training to assigned clinical research sites and support project-specific training for study teams.
• Monitor site performance by tracking enrollment, Case Report Form (CRF) data entry, protocol deviations, and other site-level metrics.
• Communicate site performance, risks, issues, and trends to the Clinical Study Team.
• Perform Serious Adverse Event (SAE) reconciliation and collaborate with sites to resolve discrepancies.
• Work with clinical study teams and investigative sites to ensure timely achievement of study milestones, including study start-up, recruitment, database activities, and close-out.
• Support regional investigator meetings and site booster visits when required.
• Assist clinical sites with audit and inspection preparation and ensure identified quality issues or findings are appropriately addressed through resolution.
• Mentor and support less experienced CRAs on general and study-specific monitoring topics.
• Participate in co-monitoring activities and provide additional support during site visits when needed.
• Undertake other clinical responsibilities within the scope of the role as assigned.

Requirements

• Bachelor's degree in a relevant scientific discipline or equivalent academic background.
• At least 2 years of relevant clinical operations experience, including a minimum of 1 year of clinical monitoring experience.
• Experience with global clinical trials is preferred, particularly within oncology or hematology.
• Pharmaceutical or biotechnology industry experience is highly desirable.
• Thorough understanding of clinical trial processes, ICH-GCP principles, and applicable regulatory requirements.
• Experience conducting site monitoring visits and managing investigative sites.
• Strong understanding of protocol compliance, data quality, patient safety, and clinical documentation requirements.
• Excellent written and verbal communication skills in English; fluency is required. Spanish is considered a plus.
• Strong interpersonal and relationship-building skills for effective collaboration with investigators, vendors, study teams, and other stakeholders.
• Excellent organizational and prioritization skills, with the ability to manage multiple activities and deadlines simultaneously.
• Ability to work independently while contributing effectively to a global, cross-functional team.
• Strong analytical, problem-solving, and attention-to-detail capabilities.
• Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
• Familiarity with clinical trial management systems (CTMS) and clinical data management systems.
• Ability and willingness to travel extensively, with up to 70% travel required.

Benefits

• Full-time, remote position based in Brazil.
• Opportunity to work on clinical trials with global scope.
• Exposure to pharmaceutical and biotechnology clinical research, with a focus on areas such as oncology and hematology.
• Opportunity to take ownership of site management and clinical monitoring activities.
• Mentoring and development opportunities through collaboration with experienced clinical research professionals.
• Opportunity to support and mentor less experienced CRAs.
• Collaborative, cross-functional, and internationally oriented working environment.
• Professional development through disease-area, project-specific, and study-related training.
• Meaningful opportunity to contribute to clinical research and the development of innovative treatments.