Senior Clinical Research Associate

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

📋 Description

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

• Provide informative context regarding clinical trials and link stakeholders with investigative sites.

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

• Support, guide, and mentor junior staff on site management tasks.

• Perform site evaluations, site training, regular on-site and off-site monitoring, and monitoring for site closures.

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

• Tailor site engagement strategies and monitor progress, impact, and local/site insights.

• Utilize scientific principles, clinical trial requirements, and therapeutic-area expertise in trial execution.

• Create recruitment and retention strategies based on the patient disease journey.

• Mentor and train less experienced CRAs while facilitating local onboarding.

• Participate in or lead both global and local task forces and initiatives.

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

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

• Identify, assess, and recommend investigators and sites for clinical studies.

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

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

• Manage investigator payments in accordance with executed contract obligations, when applicable.

• Execute additional tasks as assigned by the manager.

⛳️ Requirements

• Relevant tertiary qualification in health-related fields (e.g., Medical, Scientific, Pharmacy, Nursing) is preferred.

• At least 3 years of clinically relevant experience.

• Ideally, 2 years of independent clinical research monitoring experience with investigational drug or device trials.

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

• Understanding of appropriate therapeutic area indications and the ability to apply scientific concepts to clinical trials.

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

• Strong communication and cross-functional collaboration capabilities.

• Excellent planning and organizational skills; ability to operate effectively in a fast-paced environment with multiple projects and deadlines.

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

• Exceptional written, verbal, active listening, and presentation skills.

• Ability to build and maintain site relationships and trusted partnerships.

• Capability to independently resolve clinical site issues using functional expertise, critical thinking, and sound judgment.

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

• Self-driven and focused on achieving timely, high-quality outcomes.

• Availability for full-time work.

🏝️ Benefits

• Equal opportunity employer.

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