Clinical Research Associate II

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

📋 Description

• Propel AbbVie's clinical research pipeline forward by aiming for excellence in clinical research and utilizing advanced capabilities.

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

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

• Offer contextual insights on clinical trials and link stakeholders with investigative sites.

• Align, educate, and inspire site staff and principal investigators regarding trial objectives, protocols, and patient-treatment principles.

• Perform site evaluations, training, routine monitoring, and closure monitoring in adherence to protocols, regulations, GCP, ICH Guidelines, SOPs, and quality standards.

• Tailor site-engagement strategies and collect local/site insights using CRM tools to monitor progress and assess impact.

• Integrate study protocols, scientific principles, and clinical-trial requirements into daily trial operations.

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

• Build knowledge in therapeutic areas, assets, clinical landscapes, and patient journeys to enhance recruitment and ensure protocol compliance.

• Guide and mentor less experienced CRAs while providing development feedback.

• Engage in global/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 preventive and corrective action plans.

• Identify and assess potential investigators and sites.

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

• Uphold audit and regulatory inspection readiness.

• Oversee investigator payments as necessary.

⛳️ Requirements

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

• A minimum of 1 year of clinically related experience, including at least 6 months in clinical research monitoring of investigational drug or device trials.

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

• Knowledge of relevant therapeutic area indications is preferred.

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

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

• Excellent planning and organizational skills, capable of thriving in a dynamic environment with competing projects and deadlines.

• Advanced capability to utilize technology, tools, and resources for customer-centric site support.

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

• Capacity to establish and leverage 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-motivated and focused on achieving timely, quality outcomes in a fast-paced environment.

🏝️ Benefits

• Equal opportunity employer.

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