Clinical Research Associate II

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

📋 Description

• Propel AbbVie’s clinical development pipeline in immunology by facilitating excellence in clinical research.

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

• Act as the primary sponsor contact for 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 in site management tasks.

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

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

• Develop and tailor site engagement strategies; collect site insights and track the impact of strategies.

• Create and execute patient recruitment and retention strategies based on the patient journey.

• Mentor and train less experienced Clinical Research Associates (CRAs) and assist with local onboarding.

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

• Conduct ongoing risk assessments with the Central Monitoring team.

• Identify, assess, and recommend investigators and sites.

• Ensure data quality, timely data submissions, and safety-event reporting and follow-up.

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

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

• Implement preventative and corrective action plans to mitigate risks and ensure compliance.

⛳️ Requirements

• Preferred tertiary qualification in a health-related field (e.g., Medical, Scientific, Pharmacy, Nursing).

• Minimum of 3 years of experience in a clinically related role.

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

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

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

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

• Advanced communication and cross-functional collaboration abilities.

• Strong planning and organizational skills; capable of effectively managing competing projects and deadlines.

• Ability to utilize technology, tools, and resources for site support.

• Excellent written, verbal, active listening, presentation, interpersonal, and relationship-building skills.

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

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

• Self-motivated and dedicated to timely, quality results.

• Ability to work remotely.

🏝️ Benefits

• Option for remote work.

• Commitment to equal opportunity employment.

• Support for reasonable accommodations for applicants in the US & Puerto Rico.

• Referral opportunity/program.