Senior Clinical Research Associate
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Job Description
Senior Clinical Research Associate advancing AbbVie’s oncology medicines through clinical site monitoring in China. Ensuring trial compliance, data integrity, site performance and patient safety.
Responsibilities:
- Advance AbbVie's clinical research pipeline and translate science into medicine
- Partner with study teams, internal R&D stakeholders, investigators and site staff
- Serve as the primary sponsor point of contact for investigative sites
- Align, train and motivate site staff and principal investigators on trial goals, protocols and patient treatment principles
- Support, guide and mentor junior personnel on site management activities
- Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring
- Ensure compliance with protocols, monitoring plans, regulations, GCP, ICH Guidelines, AbbVie SOPs and quality standards
- Customize site engagement strategies and track their progress and impact
- Apply scientific and protocol knowledge to day-to-day clinical trial execution
- Develop recruitment and retention techniques based on the patient disease journey
- Mentor and train less experienced CRAs and support local onboarding
- Participate in or lead global and local task forces and initiatives
- Perform continuous risk assessment with the Central Monitoring team
- Resolve site risk signals and implement preventative and corrective action plans
- Identify, evaluate and recommend potential investigators and sites
- Ensure quality and timely submission of site data and safety-event reporting
- Maintain audit and regulatory inspection readiness at assigned sites
- Manage investigator payments according to executed contracts, as applicable
Requirements:
- Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred
- Minimum of 3 years of clinically related experience
- At least 2 years preferable in independent clinical research monitoring of investigational drug or device trials
- Familiarity with risk-based monitoring approach, onsite and offsite monitoring
- Knowledge of appropriate therapeutic area indications and ability to apply scientific concepts to clinical trial conduct
- Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies
- Advanced communication and cross-functional collaboration skills
- Superior planning and organizational skills
- Ability to work effectively in a dynamic environment with competing projects and deadlines
- Ability to leverage technology, tools and resources for customer-centric site support
- Superior written, verbal, active listening and presentation skills
- Ability to establish and leverage site relationships and trusted partnerships
- Ability to independently address clinical site issues using functional expertise, critical thinking and good judgement
- Integrity in accordance with AbbVie code of business conduct and leadership values
- Self-motivated and focused on timely, quality outcomes
Benefits:
- Employees can work remotely
- Equal opportunity employer
- Veteran and disability inclusion commitment
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