Clinical Research Associate II

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

📋 Description

• Perform qualification visits (QV), site initiation visits (SIV), monitoring visits (MV), and termination visits (TV) at designated clinical sites, while producing visit/contact reports.

• Ensure the integrity of the study and apply problem-solving skills to foster good relationships with site personnel and staff.

• Assess the trial's progress at assigned sites, making certain that the rights and well-being of human subjects are protected and comply with the protocol.

• Collaborate with the clinical site to devise patient recruitment strategies aimed at meeting enrollment deadlines, while ensuring adherence to approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and relevant regulatory requirements.

• Analyze the quality and integrity of reported data, site effectiveness, and drug accountability.

• Supervise the completeness and quality of Regulatory Documentation and conduct site document verification.

⛳️ Requirements

• Experience in Site Management or a related field in clinical research, with a solid grasp of clinical trials methodology and terminology.

• Capacity to independently carry out all clinical monitoring activities.

• Bachelor’s degree or equivalent in biological science, pharmacy, or another health-related discipline.

• Excellent interpersonal, written, and verbal communication skills within a matrixed team environment.

• Proficient in Spanish, Portuguese, and English (both written and spoken).

• Proven ability to work autonomously, demonstrating a sense of urgency and the ability to operate with minimal oversight.

• A client-oriented mindset and adaptable approach to assignments and new learning opportunities.

• Capability to juggle multiple tasks, assess various unpredictable scenarios, and meet project deadlines while applying knowledge of study protocol(s).

• A principled and ethical work ethic aimed at supporting the development of life-changing treatments for patients.

• Strong computer proficiency, including familiarity with Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), and MS-Office applications such as Excel and Word.

🏝️ Benefits

• Access to world-class technology and training tailored to your specific experience.

• Eligibility for a bonus incentive program.

• Opportunities to work across various therapeutic areas.

• Potential for career advancement in clinical research.