Clinical Research Associate

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

📋 Description

• Propel AbbVie’s clinical development pipeline through exceptional clinical research.

• Collaborate with investigators and site personnel to forge meaningful and effective clinical trial partnerships.

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

• Provide relevant information about clinical trials and link stakeholders with investigative sites.

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

• Execute site evaluations, training, routine monitoring, and closure monitoring in adherence to protocols, regulations, GCP, ICH Guidelines, AbbVie SOPs, and quality standards.

• Tailor site engagement strategies for the studies assigned.

• Collect local and site insights and utilize CRM tools to monitor progress and assess impact.

• Relate study protocols, scientific principles, and clinical trial requirements to daily execution.

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

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

• Mentor and train junior CRAs while providing developmental feedback.

• Engage in global or local task forces and initiatives.

• Execute activities assigned by management.

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

• Ensure the quality and prompt submission of site data, including safety event reporting and follow-ups.

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

• Oversee investigator payments in accordance with executed contracts, where applicable.

⛳️ Requirements

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

• At least 1 year of clinically relevant experience.

• Minimum of 6 months of clinical research monitoring experience for investigational drug or device trials.

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

• Preferred knowledge of therapeutic area indications.

• Capability to comprehend and apply scientific concepts in clinical trial execution.

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

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational abilities; adept at functioning effectively in a dynamic environment with competing projects and deadlines.

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

• Exceptional interpersonal skills along with excellent written, verbal, active listening, and presentation capabilities.

• Capacity to establish and utilize site relationships and trusted partnerships through engagement, motivation, and training.

• Proficient in applying functional expertise, critical thinking, and sound judgment to resolve clinical site issues.

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

• Self-driven and focused on achieving timely, quality outcomes in a fast-paced setting.

🏝️ Benefits

• Employees have the option to work remotely.

• Equal opportunity employer.

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