Senior CRA – Level I

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

📋 Description

• Execute and coordinate clinical monitoring and site management tasks.

• Perform both remote and on-site evaluations to ensure adherence to protocols and regulatory standards.

• Oversee sponsor procedures, guidelines, and monitoring settings.

• Guarantee that trials comply with approved protocols, ICH-GCP standards, relevant regulations, and SOPs.

• Safeguard the rights and welfare of subjects while ensuring data integrity.

• Maintain readiness for audits and foster collaborative relationships with investigational sites.

• Monitor investigator sites utilizing a risk-based monitoring strategy.

• Employ root cause analysis, critical thinking, and problem-solving to pinpoint site-process failures and implement corrective/preventive measures.

• Verify data accuracy through source document review, source data verification, and case report form evaluation.

• Evaluate investigational products via inventory and record assessments.

• Draft timely reports and correspondence documenting findings.

• Raise concerns about deficiencies and ensure issues are resolved.

• Keep in touch with investigative sites between monitoring visits.

• Carry out monitoring responsibilities as per approved monitoring plans.

• Engage in investigator payment processes.

• Monitor trial status and offer progress updates to the Clinical Team Manager.

• Update clinical study systems, including CTMS, and conduct necessary quality-control checks.

• Participate in investigator meetings and identify potential investigators.

• Initiate clinical trial sites and assist with trial closeout and material retrieval.

• Ensure essential documents are complete and perform on-site file reviews.

• Support project publications, tools, and other study-related tasks.

• Facilitate communication among investigative sites, the client organization, and the PPD project team.

• Address company, client, and regulatory requirements, including audits and inspections.

• Complete expense reports, timesheets, and other administrative duties.

• Contribute to project work and initiatives aimed at process improvement.

⛳️ Requirements

• Bachelor's degree in a life sciences field or a Registered Nursing certification, or an equivalent relevant academic/vocational qualification.

• A minimum of 3 years of hands-on clinical monitoring experience.

• Experience in clinical studies related to infectious diseases (pneumonia), respiratory issues, ophthalmology, and oncology is preferred.

• Strong clinical monitoring capabilities.

• Familiarity with medical/therapeutic area knowledge and medical terminology.

• Knowledge and demonstrated application of ICH GCPs, applicable regulations, and procedural documents.

• Critical thinking, root cause analysis, and problem-solving abilities.

• Proficient in managing Risk Based Monitoring concepts and processes.

• Strong oral and written communication skills.

• Ability to communicate effectively with medical professionals.

• Customer-oriented with strong listening skills and attention to detail.

• Excellent interpersonal, organizational, and time management skills.

• Adaptable and flexible.

• Capable of working independently as well as collaboratively in a team.

• Proficient in Microsoft Office and eager to learn necessary software.

• Good command of the English language and grammar skills.

• Strong presentation skills.

• Ability to comply with sponsor/client/site requirements, including potential vaccination status or other personal information disclosures.

• Willingness to travel frequently, generally 60–80%, including extended overnight stays.

• Capability to use required personal protective equipment and work with potential exposure to biological fluids and infectious organisms.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.

• Standard Monday–Friday work schedule.

• Frequent travel expenses likely associated with site visits.

• Opportunities for professional development through involvement in project publications, tools, process-improvement initiatives, and team discussions.