Clinical Research Associate II

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

📋 Description

• Propel AbbVie’s clinical research pipeline by aiming for excellence in clinical studies and utilizing advanced capabilities.

• Collaborate with investigators and site personnel to foster meaningful and effective partnerships.

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

• Offer contextual insights on clinical trials and facilitate connections between stakeholders and investigative sites.

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

• Execute site evaluations, training, routine monitoring, and closure activities.

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

• Tailor site engagement strategies and utilize CRM tools to report on progress and assess impact.

• Integrate study protocols, scientific principles, and clinical trial requirements into everyday execution.

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

• Build knowledge in the therapeutic area, asset, clinical landscape, and patient journey.

• Mentor and guide less experienced CRAs and assist in their professional growth.

• Engage in global/local task forces and initiatives as assigned.

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

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

• Identify, assess, and recommend investigators and sites for upcoming clinical studies.

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

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

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

⛳️ Requirements

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

• A minimum of 1 year of experience in clinically related roles.

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

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

• Preferred knowledge of relevant therapeutic area indications.

• Ability to comprehend and apply scientific concepts to the conduct of clinical trials.

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

• Strong skills in cross-functional collaboration.

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

• Advanced capability to utilize technology, tools, and resources for customer-focused site support.

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

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

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

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

• Self-driven; committed to achieving timely and high-quality outcomes in a dynamic environment.

🏝️ Benefits

• Employees can work remotely.

• Equal opportunity employer.

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