Clinical Research Associate I (CRA I) - São Paulo/SP

Job description

Job Description Join Our Team as a Clinical Research Associate (CRA)! Are you passionate about clinical research and committed to advancing healthcare? We are looking for a Clinical Research Associate (CRA) to support and manage clinical trial sites throughout all phases of the study lifecycle, ensuring compliance, data quality, and patient safety. Key Responsibilities: Serve as the primary contact for assigned research sites throughout the clinical study lifecycle. Build and maintain strong relationships with investigators and site staff. Conduct remote and on-site monitoring activities in compliance with ICH-GCP, local regulations, protocols, and company procedures. Perform site visits, including site qualification, initiation, monitoring, and close-out visits. Review and maintain study and regulatory documentation throughout study start-up, maintenance, and close-out. Support site activation activities and collaborate with cross-functional teams to achieve Site Ready status. Ensure data quality, protocol compliance, and protection of participant rights, safety, and well-being. Identify and escalate site performance, quality, or compliance issues, driving appropriate corrective actions. Maintain accurate documentation and study information in clinical systems such as CTMS and eTMF. Support audit, inspection, and co-monitoring activities when required. Main Requirements: Education: Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biology, Biomedicine, or related healthcare/scientific discipline. Other degrees may be considered with relevant healthcare experience. Experience: Previous experience in clinical research, healthcare, site coordination, clinical operations, or related areas. Experience as a Clinical Trial Assistant (CTA), Research Coordinator, Research Nurse, or similar is highly valued. Languages: Fluent Portuguese and advanced English (written and spoken). Knowledge of clinical research processes, GCP/ICH guidelines, and local regulatory requirements. Understanding of clinical trial monitoring, site management, and regulatory documentation. Experience or familiarity with clinical systems such as CTMS, eTMF, EDC, and MS Office applications. Strong organizational, communication, and stakeholder management skills. Ability to prioritize multiple tasks, work independently, and manage competing deadlines. Problem-solving mindset with the ability to identify root causes and support CAPA implementation. Ability to work effectively in a multicultural and matrix environment. Willingness to travel for on-site monitoring visits as required. #ClinicalTrialsBR Required Skills: Accountability, Accountability, Administrative Policies, Adverse Event Report, Clinical Evaluation Reports, Clinical Research Methods, Clinical Site Management, Clinical Study Management, Clinical Trial Planning, Clinical Trials, Clinical Trials Monitoring, Conflict Resolution, Data Analysis, Early Clinical Development, Good Clinical Data Management Practice (GCDMP), Investigations Training, Key Stakeholder Relationships, Pharmacovigilance, Policy Development, Preventive Action, Protocol Adherence, Proven Commitment, Regulatory Affairs Compliance, Regulatory Compliance, Regulatory Documents {+ 1 more} Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Hybrid Shift: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 07/28/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.