Clinical Research Associate II

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

📋 Description

• Propel AbbVie’s clinical development pipeline by excelling in clinical research.

• Act as the main liaison for investigative sites.

• Offer contextual insights on clinical trials and connect stakeholders with investigative sites.

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

• Conduct evaluations, training, routine monitoring, and closure activities at sites.

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

• Develop and tailor site engagement strategies while tracking their effectiveness using CRM tools.

• Assess and support patient recruitment and retention based on the patient disease journey.

• Mentor and train less experienced Clinical Research Associates (CRAs) and aid in their development.

• Engage in global and local task forces and initiatives.

• Carry out ongoing risk assessments with the Central Monitoring team and address site risk signals.

• Implement preventive and corrective action plans to mitigate risks and enhance compliance.

• Identify, evaluate, and recommend investigators and clinical sites.

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

• Maintain readiness for audits and regulatory inspections.

• Manage investigator payments when applicable.

⛳️ Requirements

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

• A minimum of 1 year of clinically related experience is required.

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

• Familiarity with risk-based monitoring, both onsite and offsite.

• Knowledge of pertinent therapeutic area indications is preferred.

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

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational abilities.

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

• Proficiency in leveraging technology, tools, and resources to provide customer-centric support.

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

• Ability to establish and cultivate site relationships and trusted partnerships.

• Capacity to apply critical thinking and sound judgment to resolve clinical site issues.

• Integrity in line with AbbVie’s code of business conduct and leadership values.

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

🏝️ Benefits

• Employees have the option to work remotely.

• We are an equal opportunity employer.

• Commitment to integrity, innovation, transforming lives, and serving the community.