Senior Clinical Research Associate

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

📋 Description

• Propel AbbVie's clinical research initiatives within the immunology therapy domain.

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

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

• Offer contextual insights regarding 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.

• Support, guide, and mentor junior staff on site management responsibilities.

• Perform site evaluations, training, regular on-site and off-site monitoring, and site closure assessments.

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

• Tailor site engagement strategies and utilize site engagement tools to track progress and assess impact.

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

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

• Mentor and train less experienced Clinical Research Associates (CRAs) and facilitate the onboarding of junior CRAs.

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

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

• Identify and address site risk indicators and implement preventive and corrective action plans.

• Evaluate and recommend potential investigators and sites.

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

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

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

⛳️ Requirements

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

• At least 3 years of experience in clinically related roles.

• A minimum of 2 years in independent clinical research monitoring of investigational drug or device trials is preferable.

• Familiarity with risk-based monitoring methodologies, both on-site and off-site.

• Understanding of relevant therapeutic area indications and scientific concepts pertaining to clinical trials.

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

• Excellent communication skills and strong cross-functional collaboration capabilities.

• Exceptional planning and organizational skills.

• Ability to navigate effectively and efficiently in a dynamic environment with competing projects and deadlines.

• Proficiency in leveraging technology, tools, and resources to offer customer-centric support.

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

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

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

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

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

🏝️ Benefits

• Employees have the flexibility to work remotely.

• We are an equal opportunity employer.

• AbbVie is dedicated to operating with integrity, fostering innovation, transforming lives, and serving the community.