Clinical Research Associate II

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

📋 Description

• Oversee activities at clinical investigative sites for AbbVie clinical trials and ensure adherence to study protocols.

• Maintain compliance with federal and local regulations, Good Clinical Practices, ICH Guidelines, AbbVie SOPs, Monitoring Plans, and quality standards.

• Conduct site qualification, initiation, interim monitoring, and study closeout visits for Phase 1–4 trials.

• Supervise site personnel activities and motivate them to achieve study objectives.

• Actively manage sites and develop action plans to ensure regulatory compliance.

• Maintain readiness for regulatory inspections at assigned clinical sites.

• Ensure the quality and timely submission of study-site data, including safety-event reporting and follow-ups.

• Safeguard the safety and well-being of study participants.

• Provide training to study-site personnel regarding protocols and regulatory requirements.

• Oversee investigator payments in accordance with contract requirements.

• Negotiate agreements with investigators and hospitals in collaboration with stakeholders.

• Complete expense reports in alignment with local and relevant guidelines.

• Identify, assess, and propose investigators and clinical sites for upcoming studies.

⛳️ Requirements

• Relevant tertiary qualification in a health-related field (e.g., Medical, Scientific, Nursing) is preferred.

• At least 3 years of experience in site monitoring.

• Proven experience in on-site monitoring of investigational drug or device trials is essential.

• Up-to-date knowledge of therapeutic indications pertinent to clinical trials.

• Comprehensive understanding of clinical research regulations, ICH/GCP Guidelines, and applicable laws.

• Strong organizational and planning skills.

• Ability to work effectively and efficiently in a fast-paced environment with competing projects and deadlines.

• Capability to comprehend and adhere to work processes within the designated function.

• Excellent analytical and conceptual skills.

• Strong interpersonal abilities and clear communication skills.

• Competence in addressing study-related clinical site issues, taking corrective actions, and conveying recommendations.

• Ability to apply functional expertise and exercise sound judgment.

• Proven business ethics and integrity.

🏝️ Benefits

• Option for remote work.

• Commitment to equal opportunity employment.

• Support for reasonable accommodations for applicants from the US & Puerto Rico.