Clinical Research Associate II

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

📋 Description

• Propel AbbVie’s clinical research pipeline by aiming for excellence in clinical research and translating scientific advancements into medicine.

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

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

• Provide contextual insights on clinical trials and connect stakeholders to investigative sites.

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

• Conduct evaluations of sites, provide training, and perform routine monitoring as well as site-closure assessments.

• Ensure adherence to protocols, monitoring plans, regulations, Good Clinical Practices (GCPs), International Council for Harmonisation (ICH) Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards.

• Tailor site-engagement strategies and utilize Customer Relationship Management (CRM) tools to report, track progress, and measure impact.

• Collect local and site-specific insights to enhance recruitment, retention, data integrity, compliance, study performance, and overall customer experience.

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

• Cultivate knowledge of the therapeutic area, asset, clinical landscape, and patient journey.

• Mentor and train junior Clinical Research Associates (CRAs) and contribute to their professional growth.

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

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

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

• Identify, evaluate, and recommend potential new investigators and sites.

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

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

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

⛳️ Requirements

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

• At least 1 year of experience in clinically related roles.

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

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

• Knowledge of relevant therapeutic area indications is preferred.

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

• Strong collaboration skills to work effectively with both internal and external stakeholders.

• Excellent planning and organizational abilities.

• Capability to operate effectively in a dynamic environment with competing projects and deadlines.

• Proficient in leveraging technology, tools, and resources.

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

• Ability to build and maintain relationships with sites through engagement, motivation, and training.

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

• Committed to acting with integrity in line with AbbVie’s code of business conduct and leadership values.

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

🏝️ Benefits

• Employees have the option to work remotely.

• We are an equal opportunity employer.

• A commitment to integrity, innovation, transforming lives, and community service.