Clinical Research Associate II

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

📋 Description

• Advance AbbVie’s clinical research pipeline and translate scientific discoveries into effective treatments for patients.

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

• Provide essential information regarding clinical trials and facilitate connections between stakeholders and investigative sites.

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

• Conduct evaluations, training sessions, routine monitoring, and closure assessments for sites.

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

• Create and tailor site engagement strategies for assigned studies.

• Collect insights from local sites and utilize CRM tools to track progress and assess impact.

• Support patient recruitment and retention efforts based on the patient disease journey.

• Develop knowledge related to therapeutic areas, assets, clinical landscapes, and patient journeys.

• Mentor and train less experienced Clinical Research Associates (CRAs) and aid in their professional growth.

• Participate in global and local task forces and initiatives as assigned.

• Conduct continuous risk assessments with the Central Monitoring team to detect study performance and patient safety concerns.

• Address site risk signals and implement preventive and corrective action plans.

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

• Ensure the quality and timely submission of site data, safety event reporting, and follow-up actions.

• Maintain readiness for audits and regulatory inspections.

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

⛳️ Requirements

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

• A minimum of 1 year of clinically related experience, including at least 6 months in clinical research monitoring of investigational drug or device trials.

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

• Knowledge of relevant therapeutic area indications is preferred.

• Capability to comprehend and apply scientific concepts in the execution of clinical trials.

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

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

• Excellent planning and organizational capabilities; ability to perform effectively in a dynamic environment with competing projects and deadlines.

• Advanced proficiency in leveraging technology, tools, and resources to provide customer-centric site support.

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

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

• Critical thinking and judgment skills to address issues at clinical sites.

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

• Self-motivated and focused on achieving timely, high-quality outcomes.

🏝️ Benefits

• Employees have the option to work remotely.

• We are an equal opportunity employer.

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