Clinical Research Associate II

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

📋 Description

• Propel AbbVie’s clinical development pipeline through exceptional clinical research.

• Collaborate with investigators and site personnel to facilitate effective clinical trial interactions.

• Act as the main liaison for the investigative site.

• Provide contextual information regarding clinical trials and connect stakeholders with investigative sites.

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

• Carry out site evaluations, training, routine monitoring, and closure assessments.

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

• Tailor site engagement strategies and monitor their progress and effectiveness using CRM tools.

• Utilize protocol, scientific, and clinical trial expertise in daily trial execution.

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

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

• Mentor and develop less experienced CRAs and contribute to their growth.

• Engage in global/local task forces and initiatives.

• Conduct ongoing risk assessments in collaboration with the Central Monitoring team.

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

• Identify and suggest potential investigators and sites.

• Ensure timely, complete, and high-quality reporting of site data and safety events.

• Maintain readiness for audits and regulatory inspections.

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

⛳️ Requirements

• Preferred tertiary qualification in health-related fields (Medical, Scientific, Nursing).

• 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.

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

• Preferred knowledge of relevant therapeutic area indications.

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

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational skills.

• Ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.

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

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

• Ability to build and leverage strong relationships and trusted partnerships with sites.

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

• Ability to act with integrity in alignment with AbbVie’s code of business conduct and leadership values.

• Self-motivated and focused on achieving timely, quality results.

🏝️ Benefits

• Employees have the option to work remotely.

• We are an equal opportunity employer.

• Reasonable accommodations are available for applicants in the US & Puerto Rico.