Senior Clinical Research Associate

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

📋 Description

• Act as the main point of contact for investigative sites on behalf of the sponsor.

• Provide context for clinical trials and facilitate connections between study stakeholders and investigative sites.

• Align, train, inspire, and guide site staff and principal investigators regarding trial objectives, protocols, and treatment principles.

• Support and mentor junior staff and Clinical Research Associates (CRAs) in site management tasks.

• Conduct evaluations of sites, provide training, and perform both routine on-site and off-site monitoring, as well as site closure monitoring.

• Tailor site engagement strategies, collect insights from sites, and monitor the progress and effectiveness of these strategies.

• Create techniques for recruitment and retention that reflect the patient disease journey.

• Take part in or lead global and local task forces and initiatives.

• Carry out ongoing risk assessments and collaborate with Central Monitoring to identify issues related to study performance and patient safety.

• Address site risk signals and execute preventative and corrective action plans.

• Identify, assess, and suggest potential investigators and clinical trial sites.

• Ensure the quality of data, prompt data submission, safety event reporting, and follow-up.

• Maintain readiness for audits and regulatory inspections at assigned sites.

• Manage investigator payments in accordance with executed contracts, as applicable.

⛳️ Requirements

• Preferred tertiary qualification in a health-related field (e.g., Medicine, Science, Pharmacy, Nursing).

• A minimum of 3 years of experience in a clinical setting.

• Ideally, 2 years of independent monitoring experience in investigational drug or device trials.

• Familiarity with risk-based monitoring as well as on-site and off-site monitoring practices.

• Knowledge of relevant therapeutic area indications and scientific principles pertaining to clinical trial execution.

• Understanding of local regulatory and legal standards, ICH/GCP Guidelines, and applicable policies.

• Excellent communication and cross-functional collaboration abilities.

• Strong planning and organizational skills; capable of managing multiple projects and deadlines effectively.

• Ability to utilize technology, tools, and resources to enhance customer-centric support for sites.

• Outstanding written, verbal, active listening, presentation, interpersonal, and relationship-building skills.

• Capacity to independently apply functional expertise, critical thinking, and sound judgment to clinical site matters.

• Integrity that aligns with AbbVie’s code of business conduct and leadership principles.

• Self-motivated with a focus on achieving timely, high-quality outcomes in a dynamic environment.

🏝️ Benefits

• Comprehensive health insurance plans.

• Opportunities for professional development and advancement.

• Flexible working arrangements and a supportive work environment.