Senior Clinical Research Associate, Brazil

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

📋 Description

• Oversee all facets of study site management to ensure patient safety and maintain high-quality data.

• Offer guidance on audit readiness and assist with audit preparation and follow-up actions.

• Maintain study-specific trial management tools, systems, and status reports.

• Manage site start-up processes, including investigator feasibility and recruitment, EC/IRB submissions, regulatory documentation, informed consents, notifications, translations, and meetings.

• Provide assistance with study budget negotiations and the execution of investigator contracts when necessary.

• Verify informed consent processes and documentation; evaluate patient safety, protocol deviations, pharmacovigilance issues, and data integrity.

• Conduct various visits, including pre-study, qualification, initiation, routine monitoring, close-out, and monitoring oversight, both on-site and remotely.

• Prepare timely and precise monitoring reports and necessary project documentation.

• Support strategies for patient recruitment, retention, and awareness.

• Review Investigator Site Files and ensure they align with Trial Master Files.

• Communicate study issues and risks to site personnel, Clinical Trial Managers, and Project Managers; implement necessary resolutions.

• Build and maintain relationships with investigators and study staff.

• Manage the inventory, storage, dispensing, administration, labeling, import, release, and return of investigational products.

• Conduct remote EDC CRF and patient profile reviews, address queries, and assist with data discrepancy resolutions.

• Process Serious Adverse Events following study procedures.

• Prepare for and participate in investigator, sponsor, global monitoring, and clinical training meetings.

• Assist with protocol and study document reviews, CRF and clinical-trial document development, and clinical study report reviews.

• Mentor and train new employees and junior monitors.

• Engage in client and proposal activities, including client presentations.

• Initiate requests for investigator payments.

• Travel as required based on project needs.

⛳️ Requirements

• A 4-year college degree or equivalent experience in a scientific or healthcare field.

• At least 5 years of experience as a CRA in a CRO or pharmaceutical/biotech industry or equivalent, relevant experience and/or demonstrated competencies.

• Significant site management experience or equivalent experience in clinical research.

• Proficient in verbal and written communication in English at a professional level.

• Experience in monitoring rare and complex therapeutic areas.

• Experience with monitoring EDC trials and EHR records.

• Background in biopharma or relevant therapeutic areas.

• Relevant country-specific site start-up experience, including feasibility, contract negotiations, and submissions.

• Capability to monitor study sites in accordance with protocol monitoring guidelines, SOPs, GCP, and ICH guidelines.

• Ability to resolve project-related challenges and prioritize workload to meet deadlines.

• Willingness to travel overnight; approximately 60% travel on average based on regional requirements, with international travel as necessary.

• Oncology experience, preferably in early phases, for select opportunities.

• Understanding of clinical trial methodology, protocols, and indications.

• Proven ability to deliver formal presentations for colleagues, investigative staff, and clients.

• A demonstrated commitment to continuous improvement.

🏝️ Benefits

• Equal Opportunity Employer.

• Reasonable accommodation available for applicants with disabilities.

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