Senior Clinical Research Associate
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Job Description
Senior Clinical Research Associate monitoring AbbVie oncology trials and supporting investigative sites in China. Driving site engagement, recruitment, compliance, risk management, and CRA mentorship.
Responsibilities:
- Serve as the primary sponsor point of contact for investigative sites
- Provide contextual information on clinical trials and connect stakeholders with 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
- Develop and customize site engagement strategies and track their progress and impact
- Apply scientific principles, clinical trial requirements, and therapeutic-area knowledge to trial execution
- Generate recruitment and retention techniques and plans 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
- Conduct continuous risk assessment with the Central Monitoring team to identify study performance or patient safety issues
- 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 contract obligations, 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
- 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 scientific concepts related to clinical trials
- Superior 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 to provide customer-centric site support
- Superior written, verbal, active listening, presentation, and interpersonal 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 judgment
- Integrity in accordance with AbbVie code of business conduct and leadership values
- Self-motivated focus on timely, quality outcomes in a fast-paced environment
Benefits:
- Remote work option
- Equal opportunity employment
- Reasonable accommodations for US & Puerto Rico applicants
- Veteran and disability-inclusive employment practices
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