Clinical Research Associate II

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

📋 Description

• Propel AbbVie’s clinical research pipeline and convert scientific advancements into medical solutions for patients.

• Act as the primary liaison for investigative sites.

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

• Align, instruct, and inspire site staff and principal investigators regarding trial objectives, protocols, and patient-treatment methodologies.

• Perform site assessments, training, routine monitoring, and site closure monitoring in accordance with protocols, monitoring plans, regulations, GCP, ICH Guidelines, SOPs, and quality standards.

• Tailor site engagement strategies for assigned studies.

• Collect local and site-specific insights and utilize CRM tools to monitor progress and evaluate impact.

• Aid in the execution of clinical trials by linking protocols, scientific principles, and trial requirements to daily operations.

• 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 ensure protocol adherence.

• Mentor and train junior CRAs and contribute to their professional growth.

• Engage in global or local task forces and initiatives.

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

• Address site-risk signals and implement preventative and corrective action plans.

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

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

• Maintain audit and regulatory inspection readiness at assigned sites.

• Oversee investigator payments in accordance with executed contract obligations, as necessary.

⛳️ Requirements

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

• A minimum of 1 year of clinically related experience is required.

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

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

• Knowledge of relevant therapeutic area indications is preferred.

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

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

• Excellent cross-functional collaboration skills.

• Strong planning and organizational abilities; capacity to work effectively in a dynamic environment with competing projects and deadlines.

• Advanced proficiency in leveraging technology, tools, and resources.

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

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

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

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

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

🏝️ Benefits

• Employees have the option to work remotely.

• We are an equal opportunity employer.

• We are committed to conducting operations with integrity, fostering innovation, transforming lives, and serving the community.