Senior Clinical Research Associate

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

📋 Description

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

• Provide relevant information about clinical trials and facilitate connections between stakeholders and investigative sites.

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

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

• Conduct evaluations of sites, provide training, and carry out routine monitoring both on-site and off-site, as well as site closure monitoring.

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

• Develop and tailor site engagement strategies while tracking their effectiveness and impact.

• Employ scientific principles, clinical trial requirements, and therapeutic-area knowledge to execute trials.

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

• Mentor and train less experienced CRAs while assisting with local onboarding processes.

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

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

• Address site risk signals and implement 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 reports.

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

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

⛳️ Requirements

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

• A minimum of 3 years of experience in clinically related roles.

• At least 2 years of experience in independent clinical research monitoring of investigational drug or device trials is preferable.

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

• Knowledge of relevant therapeutic area indications and scientific concepts related to clinical trials.

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

• Exceptional communication and cross-functional collaboration skills.

• Strong planning and organizational abilities.

• Capability to work efficiently in a dynamic environment with multiple projects and deadlines.

• Proficiency in utilizing technology, tools, and resources to deliver customer-focused site support.

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

• Ability to build and leverage relationships with sites and establish trusted partnerships.

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

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

• Self-motivated focus on delivering timely, high-quality outcomes in a fast-paced environment.

🏝️ Benefits

• Option for remote work.

• Commitment to equal opportunity employment.

• Provision of reasonable accommodations for applicants from the US & Puerto Rico.

• Inclusion of veteran and disability-friendly employment practices.