Clinical Research Associate II

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

📋 Description

• Acts as the main point of contact for the Sponsor at the investigative site, providing relevant information about clinical trials, linking stakeholders to the sites, and enhancing AbbVie’s presence.

• Aligns, trains, and inspires the site staff and principal investigator while offering support as needed regarding the objectives of the clinical trial program, protocol, and patient treatment principles, fostering a trustworthy partnership.

• Performs site evaluations, training sessions, routine monitoring both on-site and off-site, and site closure activities with necessary support, ensuring compliance with the protocol, monitoring plans, applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards in clinical research to safeguard study participants.

• Tailors the site engagement strategy for assigned studies with additional support as required. Collects local/site insights and employs site engagement tracking tools to report, monitor progress, and assess the effectiveness of that strategy.

• Demonstrates a fundamental understanding of connecting the study protocol, scientific principles, and clinical trial requirements to the daily execution of clinical trial activities. Assesses and ensures effective recruitment and retention techniques/plans based on the patient disease journey. Develops a strong knowledge base of the therapeutic area, asset, and clinical landscape/patient journey to facilitate successful patient recruitment and overall protocol adherence.

• Conducts continuous risk assessments proactively, collaborating with the Central Monitoring team to oversee activities at clinical sites, identifying early signs of overall study performance or patient safety concerns. Utilizes critical thinking to address site risk signals while maintaining a thorough understanding of site processes to drive study execution. Implements preventative and corrective action plans as necessary to mitigate risks and enhance compliance through a customer-centric approach.

• Identifies, evaluates, and recommends potential new investigators/sites with assistance from more experienced Site Monitors as needed.

• Ensures the quality of data submitted from study sites and guarantees timely data submission, including proper reporting and follow-up on all safety events by site personnel.

• Maintains audit and regulatory inspection readiness at assigned clinical sites at all times.

• Manages investigator payments in accordance with executed contract obligations, as applicable.

⛳️ Requirements

• Preferred tertiary qualification in health-related fields (e.g., Medical, Scientific, Pharmacy, Nursing) or equivalent work experience.

• Clinical experience in clinical research coordination or data management is preferred.

• Preferred knowledge of relevant therapeutic area indications with the capacity to comprehend and apply scientific concepts in the conduct of clinical trials.

• Familiarity with existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.

• Ability to collaborate and work cross-functionally to build and maintain professional relationships.

• Exhibits planning and organizational skills, capable of working efficiently in a dynamic environment with multiple projects and deadlines.

• Proficient in leveraging technology, tools, and resources to provide customer-centric support based on site health.

• Strong interpersonal skills with excellent written, verbal, active listening, and presentation abilities, capable of establishing and utilizing site relationships and trusted partnerships through engagement, motivation, and training.

• Acts with integrity in line with AbbVie’s code of business conduct and leadership values. A self-driven individual focused on delivering timely and high-quality outcomes in a fast-paced environment.

🏝️ Benefits

• Health insurance

• Professional development opportunities