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Sr CRA I (Multi-sponsor) - Brazil Home Based

Syneos Health, Inc.

Job Overview

Location

BRA-Remote

Job Type

Full-time

Full Job Description

📋 Description

• Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remote) to ensure compliance with ICH-GCP, Good Pharmacoepidemiology Practice (GPP), and protocol requirements.
• Verify proper documentation and execution of informed consent for all subjects/patients, ensuring confidentiality and protection of patient rights.
• Conduct source document review and verify accuracy and completeness of clinical data entered into case report forms (CRFs), applying query resolution techniques both remotely and on-site.
• Monitor and ensure compliance with electronic data capture systems and validate site adherence to required data entry standards.
• Manage investigational product (IP) inventory, reconciliation, storage, and security; confirm IP dispensing and administration align with protocol and regulatory guidelines.
• Review and reconcile Investigator Site File (ISF) contents with the Trial Master File (TMF), ensuring timely, accurate, and complete archiving of essential documents per local regulations.
• Document all monitoring activities through confirmation letters, trip reports, follow-up letters, and communication logs in accordance with company SOPs and Clinical Monitoring/Site Management Plans.
• Support subject recruitment and retention strategies, entering observations and action items into tracking systems to ensure timely resolution.
• Act as primary liaison between study sites and project teams, providing training and guidance to site personnel on regulatory and protocol requirements.
• Prepare for and participate in Investigator Meetings, sponsor meetings, and clinical training sessions as required by project specifications.
• Ensure sites are audit-ready by maintaining compliance with regulatory standards and supporting preparation for and follow-up of audits.
• Maintain current knowledge of ICH/GCP guidelines, applicable regulations, and company SOPs; complete all mandatory training on time.
• For Real World Late Phase studies, perform chart abstraction and data collection, collaborate with Sponsor affiliates, medical science liaisons, and local country staff, and proactively identify potential sites based on local treatment patterns and HCP associations.
• Manage site-level activities within project scope, budgets, and timelines, adapting quickly to changing priorities to meet deliverables.
• May train junior staff and communicate out-of-scope activities to Lead CRA or Project Manager.
• Travel up to 75% regularly to conduct on-site monitoring activities across Brazil.

🎯 Requirements

• Bachelor’s degree or RN in a related field or equivalent combination of education, training, and experience
• Knowledge of Good Clinical Practice (GCP)/ICH Guidelines and applicable regulatory requirements
• Demonstrated ability to manage up to 75% regular travel
• Excellent communication, presentation, and interpersonal skills
• Proficiency in computer systems and willingness to adopt new technologies

🏖️ Benefits

• Career development and progression opportunities
• Technical and therapeutic area training
• Supportive and engaged line management
• Peer recognition and total rewards program
• Inclusive workplace culture focused on authenticity and purpose
• Participation in a global team driving impact in healthcare

Skills & Technologies

GCP

Senior

Remote

Degree Required

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Syneos Health, Inc.

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About Syneos Health, Inc.

Syneos Health is a global biopharmaceutical services organization providing clinical and commercial solutions. It integrates clinical development, outsourced commercialization, consulting, and communications services to accelerate the delivery of therapies to market. The company supports pharmaceutical, biotechnology, and medical device clients across all phases of product development and commercialization, operating in North America, Europe, and Asia-Pacific.

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