Senior Clinical Research Associate

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

📋 Description

• Propel AbbVie’s oncology clinical research initiatives and facilitate innovative medicines and solutions.

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

• Act as the primary sponsor liaison for investigative sites.

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

• Support, guide, and mentor junior team members and CRAs in site-management tasks.

• Conduct site evaluations, provide training, and perform routine onsite/offsite monitoring, as well as site-closure assessments.

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

• Create and tailor site-engagement strategies; collect site insights and monitor the effectiveness of those strategies.

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

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

• Perform continuous risk assessments with the Central Monitoring team and address site risk indicators.

• Implement preventative and corrective action plans to minimize risk and enhance compliance.

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

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

• Maintain audit and regulatory inspection readiness at designated sites.

• Manage investigator payments in accordance with executed contract obligations, as applicable.

⛳️ Requirements

• A minimum of 3 years of clinically related experience.

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

• An appropriate tertiary qualification in a health-related field (e.g., Medical, Scientific, Pharmacy, Nursing) is preferred.

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

• Knowledge of therapeutic-area indications and scientific concepts pertinent to clinical trials.

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

• Advanced communication and cross-functional collaboration abilities.

• Exceptional planning and organizational skills; adept at managing multiple projects and deadlines.

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

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

• Ability to independently resolve clinical site issues using functional expertise, critical thinking, and sound judgment.

• Integrity aligned with AbbVie’s code of business conduct and leadership values.

• Self-motivated and focused on achieving timely, quality outcomes in a dynamic environment.

🏝️ Benefits

• Employees have the option to work remotely.

• Equal opportunity employer.

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