Clinical Research Associate II

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

📋 Description

• Propel AbbVie’s clinical development pipeline by ensuring excellence in clinical research

• Collaborate with investigators and site personnel to enhance effective engagement in clinical trials

• Act as the main point of contact for investigative sites

• Provide relevant clinical trial information and facilitate connections between stakeholders and investigative sites

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

• Carry out site evaluations, training, routine monitoring, and closure activities in adherence to protocols, monitoring plans, regulations, GCP, ICH Guidelines, AbbVie SOPs, and quality standards

• Tailor site engagement strategies and utilize CRM tools to monitor progress and assess impact

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

• Assess recruitment and retention strategies based on the patient disease journey

• Cultivate knowledge in therapeutic areas, assets, clinical landscapes, and patient journeys to aid in recruitment and protocol adherence

• Mentor and train junior CRAs and support their professional growth

• Engage in 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 preventive and corrective action plans

• Identify and assess potential investigators and sites

• Ensure data integrity, prompt data submission, and appropriate safety event reporting and follow-up

• Maintain readiness for audits and regulatory inspections at assigned sites

• Oversee investigator payments in line with executed contract obligations, when applicable

⛳️ Requirements

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

• A minimum of 1 year of clinically related experience

• At least 6 months of experience in clinical research monitoring for investigational drug or device trials

• Understanding of risk-based monitoring techniques, both onsite and offsite

• Preferred knowledge of relevant therapeutic area indications

• Capability to comprehend and apply scientific principles to the conduct of clinical trials

• Advanced understanding of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies

• Strong skills in cross-functional collaboration with both internal and external stakeholders

• Excellent planning and organizational abilities; capable of working effectively and efficiently in a fast-paced environment with competing projects and deadlines

• Advanced proficiency in leveraging technology, tools, and resources for customer-centric site support

• Strong interpersonal, written, verbal, active listening, and presentation skills

• Ability to build and maintain site relationships and trusted partnerships through engagement, motivation, and training

• Capacity to apply critical thinking and sound judgment to clinical site challenges

• Integrity in line with AbbVie's code of business conduct and leadership values

• Self-motivated and dedicated to achieving timely, high-quality outcomes in a dynamic environment

🏝️ Benefits

• Employees have the option to work remotely

• Equal opportunity employer

• Commitment to integrity, innovation, life transformation, and community service