Clinical Research Associate

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

📋 Description

• Oversees investigator sites utilizing a risk-based monitoring strategy: employs root cause analysis (RCA), critical thinking, and problem-solving abilities to pinpoint failures in site processes and implement corrective/preventive measures to ensure compliance and mitigate risks.

• Guarantees data integrity through SDR, SDV, and CRF evaluations as necessary via both on-site and remote monitoring activities.

• Records findings in reports and correspondence promptly, adhering to established business writing standards.

• Executes monitoring responsibilities in line with the approved monitoring plan.

• Verifies that essential documents are complete and properly filed, in accordance with ICH-GCP and relevant regulations.

• Promotes effective communication between investigative sites, the client organization, and the PPD project team through written, verbal, and/or electronic interactions.

⛳️ Requirements

• Bachelor's degree in a field related to life sciences.

• Prior experience that equips the candidate with the knowledge, skills, and abilities necessary for the role (equivalent to over 2 years as a clinical research monitor).

• Proficient clinical monitoring capabilities.

• Proven understanding of medical/therapeutic areas and medical terminology.

• Strong grasp and demonstrated application of ICH GCPs, relevant regulations, and procedural documents.

• Well-honed critical thinking abilities, encompassing a critical mindset, thorough investigation for accurate root cause analysis, and effective problem-solving.

• Capability to manage Risk Based Monitoring concepts and processes.

• Strong oral and written communication skills, with the ability to engage effectively with medical professionals.

• Ability to maintain a customer-centric approach through excellent listening skills, attention to detail, and the ability to discern underlying customer issues.

• Capacity to work collaboratively in a team or independently as needed.

• Competent computer skills: proficient in Microsoft Office and able to learn relevant software quickly.

🏝️ Benefits

• Flexible work arrangements.

• Opportunities for professional development.