Clinical Research Associate II

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

📋 Description

• Propel AbbVie’s clinical pipeline forward by delivering outstanding performance in clinical research and advanced capabilities.

• Act as the main liaison for the investigative site.

• Offer contextual details regarding clinical trials and connect stakeholders to investigative sites.

• Align, educate, and inspire site staff and principal investigators on trial objectives, protocols, and patient treatment principles.

• Conduct evaluations of sites, provide training, engage in routine monitoring, and perform site closure activities.

• Ensure adherence to protocols, monitoring plans, relevant regulations, GCPs, ICH Guidelines, AbbVie SOPs, and quality standards.

• Create and tailor site engagement strategies for designated studies.

• Collect insights from local and site levels; utilize CRM tools to monitor progress and assess impact.

• Link study protocols, scientific principles, and clinical trial requirements to day-to-day trial execution.

• Assess and guarantee effective patient recruitment and retention strategies/plans.

• Develop knowledge in therapeutic areas, assets, clinical landscapes, and patient journeys.

• Mentor and train junior CRAs and support their professional growth.

• Engage in global and local task forces and initiatives.

• Perform ongoing risk assessments with the Central Monitoring team to identify study performance or patient safety concerns.

• Address site risk signals and implement both preventative and corrective action plans.

• Identify, assess, and recommend potential investigators and sites.

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

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

• Manage investigator payments as per executed contract obligations, where applicable.

• Undertake additional tasks assigned by the manager.

⛳️ Requirements

• Relevant tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) is preferred.

• A minimum of 1 year of experience in a clinically related role.

• At least 6 months of experience in clinical research monitoring for investigational drug or device trials is required.

• Understanding of a risk-based monitoring approach, including both onsite and offsite monitoring.

• Familiarity with appropriate therapeutic area indications is preferred.

• Ability to comprehend and apply scientific concepts to the conduct of clinical trials.

• Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.

• Strong skills in cross-functional collaboration among internal and external stakeholders.

• Excellent planning and organizational abilities; capable of working effectively and efficiently in a dynamic environment with competing projects and deadlines.

• Advanced capability to utilize technology, tools, and resources for customer-focused site support.

• Strong interpersonal, written, verbal, active listening, and presentation skills.

• Proficient in establishing and leveraging site relationships and trusted partnerships through engagement, motivation, and training.

• Ability to apply critical thinking and sound judgment to address clinical site challenges.

• Conducts oneself with integrity in alignment with AbbVie’s code of business conduct and leadership values.

• Self-driven and focused on achieving timely, quality outcomes in a fast-paced environment.

🏝️ Benefits

• Employees have the option to work remotely.

• Equal opportunity employer.

• Dedication to operating with integrity, fostering innovation, transforming lives, and serving the community.