Clinical Research Associate II

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

📋 Description

• Enhance AbbVie’s clinical development pipeline through exemplary clinical research.

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

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

• Offer contextual insights on 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.

• Conduct evaluations of sites, provide training, perform routine monitoring, and oversee site closure monitoring.

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

• Develop and tailor site engagement strategies for assigned studies.

• Collect local and site insights and utilize CRM tools to track progress and assess impact.

• Support plans for recruitment and retention based on the patient disease journey.

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

• Mentor and train less experienced CRAs, contributing to their professional development.

• Participate in global or local task forces and initiatives.

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

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

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

• Ensure timely and accurate data submission, as well as 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, as applicable.

⛳️ Requirements

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

• A minimum of 1 year of clinically related experience.

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

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

• Preferred knowledge of relevant therapeutic area indications.

• Ability to comprehend and apply scientific concepts to the conduct of clinical trials.

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

• Strong cross-functional collaboration abilities among internal and external stakeholders.

• Excellent planning and organizational capabilities; ability to function effectively in a dynamic environment with multiple projects and deadlines.

• Proficient in leveraging technology, tools, and resources to provide customer-oriented site support.

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

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

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

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

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

🏝️ Benefits

• Employees have the option to work remotely.

• We are an equal opportunity employer.

• Commitment to integrity, innovation, transforming lives, and community service.