Senior Clinical Research Associate

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

📋 Description

• Advance AbbVie's oncology clinical research pipeline and support the development of innovative medicines.

• Collaborate with study teams, internal R&D stakeholders, investigators, and site personnel.

• Act as the primary sponsor point of contact for investigative sites.

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

• Mentor and assist junior personnel and CRAs in site management activities.

• Conduct evaluations of sites, provide training, carry out routine on-site and off-site monitoring, and perform site closure monitoring.

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

• Develop and tailor site engagement strategies; collect site insights and assess the impact of strategies.

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

• Acquire knowledge of the oncology therapeutic area, assets, clinical landscape, and patient journey.

• Participate in or lead both global and local task forces and initiatives.

• Conduct ongoing risk assessments in collaboration with the Central Monitoring team.

• Address site risk signals and execute preventative and corrective action plans.

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

• Ensure the quality and timely submission of site data and safety event reporting.

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

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

⛳️ Requirements

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

• A minimum of 3 years of clinically related experience is required.

• At least 2 years of experience in independent clinical research monitoring of investigational drug or device trials is preferred.

• Familiarity with risk-based monitoring approaches, both on-site and off-site.

• Understanding of therapeutic area indications and the ability to apply scientific concepts to clinical trials.

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

• Strong communication and cross-functional collaboration skills.

• Excellent planning and organizational capabilities.

• Ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.

• Proficiency in leveraging technology, tools, and resources for site support focused on customer needs.

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

• Capability to establish and foster site relationships and trusted partnerships.

• Ability to independently utilize functional expertise, critical thinking, and judgment to resolve clinical site issues.

• 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.

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