Senior Clinical Research Associate

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

📋 Description

• Enhance AbbVie's clinical research pipeline by promoting excellence in clinical research.

• Collaborate with study teams, internal R&D stakeholders, investigators, and site personnel.

• Act as the primary sponsor liaison for the investigative site.

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

• Provide support, guidance, and mentorship to junior staff and CRAs on site management tasks.

• Perform site evaluations, training sessions, routine on-site and off-site monitoring, and site closure monitoring.

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

• Tailor site engagement strategies and monitor progress and impact using site engagement tools.

• Utilize protocol, scientific, and clinical trial knowledge in daily trial execution.

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

• Build expertise in the therapeutic area, asset, clinical landscape, and patient journey.

• Participate in or lead global and local task forces and initiatives.

• Conduct ongoing risk assessments in partnership with the Central Monitoring team.

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

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

• Ensure the quality and timely submission of site data and safety-event reporting.

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

• Manage investigator payments in accordance with executed contracts, where applicable.

⛳️ Requirements

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

• At least 3 years of clinically related experience is required.

• Ideally, 2 years of independent clinical research monitoring experience for investigational drug or device trials.

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

• Understanding of therapeutic area indications and the ability to apply scientific concepts to clinical trials.

• Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and relevant policies.

• Advanced communication and cross-functional collaboration skills are essential.

• Excellent planning and organizational abilities are required.

• Capable of working effectively in a dynamic environment with competing projects and deadlines.

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

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

• Ability to cultivate and utilize site relationships and trusted partnerships.

• Competent in independently resolving clinical site issues using functional expertise, critical thinking, and sound judgment.

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

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

🏝️ Benefits

• Employees have the option to work remotely.

• Equal opportunity employer.

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