Senior Clinical Research Associate in Brazil at Jobgether

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Clinical Research Associate based in Brazil.

This role offers the opportunity to support complex and advanced clinical trials across Brazil within a global clinical research environment.
You will take ownership of site management, monitoring, study start-up, and ongoing trial activities while maintaining a strong focus on patient safety and data quality.
The position combines clinical expertise, regulatory knowledge, operational oversight, and close collaboration with investigators and study teams.
You will work across different stages of clinical research, from feasibility and site initiation through routine monitoring and study close-out.
The role also provides opportunities to contribute to audit readiness, risk management, recruitment strategies, and continuous improvement.
You will collaborate with Clinical Trial Managers, Project Managers, data teams, sponsors, investigators, and junior clinical research professionals.
This is an excellent opportunity for an experienced CRA seeking to take on complex assignments, mentor colleagues, and make a meaningful contribution to high-quality clinical research.

• Independently oversee all aspects of study site management, ensuring patient safety, data quality, protocol compliance, and consistently strong quality outcomes.
• Provide guidance at site and project levels to support audit readiness, including preparation for audits and completion of required follow-up actions.
• Establish, update, track, and maintain study-specific trial management tools, systems, and status reports.
• Manage site start-up activities, including feasibility assessments, investigator recruitment, EC/IRB submissions, regulatory document collection and review, informed consent documentation, notifications, translations, meetings, and other study implementation activities.
• Support study budget negotiations and investigator contract execution when required, working within established procedures.
• Verify that informed consent has been appropriately obtained and documented for study participants.
• Assess risks affecting patient safety and data integrity, including protocol deviations, violations, and pharmacovigilance issues.
• Independently conduct pre-study/qualification, initiation, routine monitoring, and close-out visits in accordance with protocols, local regulations, ICH-GCP, SOPs, and monitoring plans.
• Perform monitoring oversight visits when required to assess the work of other CRA team members.
• Prepare accurate and timely monitoring reports for on-site and remote visits.
• Document study activities through confirmation letters, follow-up letters, trip reports, communication logs, tracking systems, and other required project documentation.
• Support patient recruitment, retention, and awareness strategies while tracking observations, action items, and resolutions.
• Routinely review Investigator Site Files for accuracy, completeness, and timeliness, and reconcile essential documentation with the Trial Master File.
• Ensure investigator sites understand and comply with applicable requirements for archiving essential documents.
• Maintain proactive communication with site personnel, Clinical Trial Managers, Project Managers, and other study stakeholders regarding protocol issues, deviations, risks, and required actions.
• Build strong working relationships with investigators and study staff while representing high standards of quality and professionalism.
• Perform investigational product inventory and reconciliation activities, reviewing storage, security, dispensing, administration, labeling, importation, release, and return procedures.
• Review blinded and randomized investigational product information and identify potential issues or risks in accordance with applicable procedures.
• Conduct data review activities, including EDC/CRF and patient profile reviews, query resolution, and collaboration with data management and clinical data quality teams.
• Identify and process Serious Adverse Events according to study-specific procedures and demonstrate a thorough understanding of SAE reporting requirements.
• Identify site-level risks, escalate them appropriately, recommend contingencies, and support timely resolution under project team oversight.
• Prepare for and participate in Investigator Meetings, sponsor meetings, global monitoring meetings, and clinical training sessions.
• Prepare or contribute to study-specific presentations, training materials, and operational tools when required.
• Support the preparation and review of protocols, clinical study documentation, CRFs, monitoring guidelines, operating manuals, and other trial materials.
• Assist with the review of clinical study reports.
• Mentor and support the training and development of junior CRAs and new team members.
• Participate in client-facing activities and proposal development, including presentations when required.
• Initiate investigator payment requests and support related administrative processes.
• Travel as required based on project needs, including overnight and international travel when applicable.
• Contribute proactively to process improvements that increase efficiency, quality, and effectiveness across clinical research activities.

Requirements:

• Bachelor’s degree or equivalent experience in a scientific, healthcare, or related discipline.
• At least 5 years of experience as a CRA within a CRO, pharmaceutical, biotechnology, or equivalent clinical research environment.
• Significant experience managing clinical research sites and/or comparable clinical trial responsibilities.
• Strong understanding of clinical trial methodology, protocols, therapeutic indications, and clinical monitoring practices.
• Professional-level proficiency in English, both written and verbal.
• Ability to independently plan and organize work while effectively collaborating within multidisciplinary teams.
• Experience monitoring clinical trial sites according to protocols, monitoring guidelines, SOPs, GCP, and ICH-GCP requirements.
• Strong knowledge of site start-up activities, including feasibility, investigator selection, regulatory submissions, and contract-related processes.
• Experience with EDC systems and electronic health records is desirable.
• Experience in rare or complex therapeutic areas is preferred.
• Previous experience in biopharma or a relevant therapeutic area is an advantage.
• Oncology monitoring experience, particularly in early-phase studies, is desirable for applicable opportunities.
• Strong problem-solving skills and the ability to prioritize workloads, resolve project-related issues, and meet deadlines.
• Ability to identify risks, recommend appropriate solutions, and escalate issues when necessary.
• Strong presentation and communication skills, with the ability to engage effectively with colleagues, investigators, clients, and other stakeholders.
• Experience delivering formal presentations to diverse professional audiences.
• Demonstrated ability to mentor junior CRAs and contribute to team development.
• Strong attention to detail and commitment to patient safety, data integrity, quality, and regulatory compliance.
• Self-motivated and proactive approach to work, with the ability to operate independently and within a collaborative team environment.
• Demonstrated commitment to continuous improvement and the ability to identify opportunities to make processes more efficient and teams more effective.
• Willingness and ability to travel overnight, with up to approximately 60% travel depending on regional and project requirements, plus international travel when needed.
• Graduate or postgraduate education is preferred.

Benefits:

• Remote work model based in Brazil.
• Opportunity to contribute to complex and advanced clinical research programs.
• Exposure to diverse therapeutic areas, clinical trial methodologies, and international study teams.
• Opportunities to work with multidisciplinary teams across clinical operations, data management, project management, and other functions.
• Professional development through clinical training, project-specific learning, and exposure to advanced clinical research practices.
• Opportunities to mentor junior clinical research professionals and contribute to team development.
• Participation in Investigator Meetings, sponsor meetings, global project meetings, and other professional forums.
• Opportunity to contribute to audit readiness, risk management, quality improvement, and clinical research best practices.
• Potential for international exposure and travel based on project requirements.
• Inclusive equal-opportunity environment committed to fair employment practices and accessibility.