Clinical Research Associate II

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

📋 Description

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

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

• Act as the primary liaison for investigative sites.

• Provide comprehensive information about clinical trials and connect stakeholders with investigative sites.

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

• Execute site evaluation, training, routine monitoring, and site closure activities in adherence to protocols, monitoring plans, regulations, GCP, ICH Guidelines, SOPs, and quality standards.

• Design and tailor site engagement strategies for assigned studies.

• Collect local and site-specific insights and utilize CRM tools to monitor progress and evaluate impact.

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

• Develop knowledge of therapeutic areas, assets, clinical landscapes, and patient journeys to enhance recruitment and protocol adherence.

• Guide and mentor less experienced Clinical Research Associates (CRAs) and support their professional development.

• Engage in global and local task forces and initiatives as assigned.

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

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

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

• Ensure data integrity and prompt submissions, including safety event reporting and follow-up.

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

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

⛳️ Requirements

• At least 1 year of relevant clinical experience.

• A minimum of 6 months of experience in clinical research monitoring of investigational drug or device trials.

• Understanding of risk-based monitoring approaches, 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 collaboration skills across internal and external stakeholders.

• Excellent planning and organizational abilities; capacity to operate efficiently in a dynamic environment with competing projects and deadlines.

• Proficient in leveraging technology, tools, and resources for customer-focused site support.

• Strong interpersonal abilities complemented by excellent written, verbal, active listening, and presentation skills.

• Capability to establish and nurture site relationships and trusted partnerships through engagement, motivation, and training.

• Ability to apply functional expertise, critical thinking, and sound judgment to resolve clinical site challenges.

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

• Self-driven and committed to delivering timely, high-quality results.

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

🏝️ Benefits

• Employees have the option to work remotely.

• We are an equal opportunity employer.

• Reasonable accommodations are provided for applicants from the US & Puerto Rico.