Clinical Research Associate II

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

📋 Description

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

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

• Provide relevant information regarding clinical trials and facilitate connections between stakeholders and investigative sites.

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

• Execute site evaluations, training, routine monitoring, and closure monitoring.

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

• Tailor site engagement strategies and track progress utilizing CRM tools.

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

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

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

• Guide and mentor less experienced Clinical Research Associates (CRAs).

• Engage in global or local task forces and initiatives.

• Perform ongoing risk assessments alongside the Central Monitoring team.

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

• Identify and recommend suitable investigators and sites for clinical studies.

• Ensure high data quality, prompt data submission, and safety-event reporting.

• Maintain readiness for audits and regulatory inspections.

• Oversee investigator payments in accordance with executed contract obligations, where applicable.

⛳️ Requirements

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

• A minimum of 1 year of experience in clinically related roles.

• 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 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 capabilities.

• Ability to thrive in a dynamic environment with multiple projects and deadlines.

• Proficient in leveraging technology, tools, and resources effectively.

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

• Capability to build and leverage relationships with sites through engagement, motivation, and training.

• Strong critical thinking and sound judgment for addressing clinical site issues.

• Adherence to AbbVie’s code of business conduct and leadership values.

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

🏝️ Benefits

• Option for remote work.

• Commitment to equal opportunity employment.

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

• Employee referral opportunities.