Clinical Research Associate

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

📋 Description

• Acts as the primary point of contact for the Sponsor at the investigative site, providing contextual information on clinical trials, facilitating connections between stakeholders and investigative sites, and enhancing AbbVie’s positioning.

• Aligns, trains, and motivates the site staff and principal investigator, offering support as needed on the goals of the clinical trial program, protocol, and patient treatment principles to foster a trusted partnership.

• Conducts site evaluations, site training, routine on-site and off-site monitoring, and site closure activities with support as necessary, ensuring compliance with the protocol and monitoring plans, as well as adherence to applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards in clinical research, prioritizing the safety and protection of study subjects.

• Develops customized site engagement strategies for assigned study(ies) with appropriate support. Collects local/site insights and utilizes site engagement tracking tools to report and measure the progress and impact of those strategies.

• Demonstrates a fundamental level of competency in connecting the study protocol, scientific principles, and clinical trial requirements to daily clinical trial execution activities. Evaluates and ensures effective recruitment and retention techniques/plans based on the patient disease journey. Acquires in-depth knowledge of the therapeutic area, asset, and clinical landscape/patient journey to facilitate successful patient recruitment and overall protocol compliance.

• Engages in continuous risk assessment proactively and collaborates with the Central Monitoring team to oversee activities conducted by clinical sites, detecting early overall study performance or patient safety issues. Utilizes critical thinking to resolve site risk signals while maintaining a robust understanding of site processes to drive study execution. Ensures the implementation of preventative and corrective action plans as needed to mitigate risks and promote compliance through a customer-centric approach.

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

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

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

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

⛳️ Requirements

• Preferably holds an appropriate tertiary qualification in health-related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) or possesses relevant experience or equivalent work experience.

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

• Familiarity with appropriate therapeutic area indications is preferred, along with the ability to understand and apply scientific concepts relevant to the conduct of clinical trials.

• Knowledge of existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines, and relevant policies.

• Capable of working collaboratively and cross-functionally to develop and maintain effective working relationships.

• Exhibits planning and organizational skills with the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.

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

• Possesses strong interpersonal skills, including written, verbal, and active listening skills, as well as presentation capabilities, with the ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.

• Able to utilize functional expertise with appropriate guidance, apply critical thinking skills, and exercise good judgment to address clinical site issues.

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

🏝️ Benefits

• Health insurance

• Retirement plans

• Paid time off