Senior Clinical Research Associate

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

📋 Description

• Execute and oversee clinical monitoring and site management tasks.

• Conduct both remote and on-site visits to evaluate compliance with protocols and regulations.

• Manage necessary documentation, sponsor procedures, and monitoring guidelines.

• Ensure that trials adhere to approved protocols, ICH-GCP guidelines, relevant regulations, and SOPs.

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

• Utilize a risk-based monitoring strategy to oversee investigator sites.

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

• Guarantee data accuracy through thorough source document review, source data verification, and CRF assessment.

• Evaluate investigational products through inventory checks and record assessments.

• Prepare prompt reports and correspondence, escalate deficiencies, and ensure issues are resolved.

• Maintain communication with sites between visits and carry out monitoring activities as outlined in monitoring plans.

• Engage in investigator payment processes.

• Monitor trial status and provide regular updates to the Clinical Team Manager.

• Update clinical trial systems and conduct quality checks of CTMS reports.

• Attend investigator meetings and identify potential candidates for investigation.

• Initiate clinical trial sites and offer compliance recommendations.

• Ensure trial closure and the retrieval of trial materials.

• Verify the completeness of essential documents and carry out on-site file reviews.

• Assist with project publications/tools and other study-related tasks as assigned by the CTM.

• Facilitate communication among investigational sites, the client company, and the PPD project team.

• Ensure compliance with company, client, and regulatory requirements, including audits and inspections.

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

• Contribute to initiatives aimed at process improvement.

⛳️ Requirements

• Bachelor’s degree in a life science-related discipline.

• A minimum of 2 years of experience as a clinical research monitor or similar relevant experience providing necessary knowledge, skills, and abilities.

• Equivalency may be considered based on a combination of relevant education, training, and/or directly related experience.

• Strong clinical monitoring abilities.

• Knowledge of medical/therapeutic areas and medical terminology.

• Excellent comprehension and application of ICH GCPs, relevant regulations, and procedural documents.

• Strong critical thinking, root cause analysis, and problem-solving capabilities.

• Proficiency in managing Risk-Based Monitoring concepts and processes.

• Effective verbal and written communication skills, including interaction with medical personnel.

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

• Strong interpersonal, organizational, and time management abilities.

• Flexibility and adaptability.

• Capability to work independently as well as part of a team.

• Proficiency in Microsoft Office and willingness to learn relevant software.

• Good command of the English language and grammar.

• Strong presentation skills.

• Ability to meet specific sponsor/client/site requirements, which may include disclosing vaccination status or other personal information.

• Willingness to travel frequently, typically 60–80%, including regular drives to site locations and potential extended overnight stays.

• Ability to work in office, laboratory, clinical, and/or home office settings.

• Capability to use necessary personal protective equipment, including protective eyewear, garments, and gloves.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.