Senior Clinical Research Associate
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Job Description
Senior Clinical Research Associate advancing AbbVie’s oncology medicines through clinical site oversight in China. Ensuring trial compliance, data integrity, patient safety, recruitment and investigator partnerships.
Responsibilities:
- Advance AbbVie's oncology clinical research pipeline and support innovative medicines
- 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
- Mentor and support junior personnel and CRAs 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; gather site insights and track strategy impact
- Generate and implement patient recruitment and retention techniques based on the disease journey
- Develop knowledge of the oncology therapeutic area, asset, clinical landscape and patient journey
- Participate in or lead global and local task forces and initiatives
- Conduct 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 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
- 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 therapeutic area indications and ability to understand and apply scientific concepts to clinical trials
- 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 and efficiently in a dynamic environment with competing projects and deadlines
- Ability to leverage technology, tools and resources for customer-centric site support
- Superior interpersonal, written, verbal, active listening and presentation skills
- Ability to establish and leverage site relationships and trusted partnerships
- Ability to independently use functional expertise, critical thinking and judgment to address clinical site issues
- Integrity in accordance with AbbVie code of business conduct and leadership values
- Self-motivated and focused on timely, quality outcomes in a fast-paced environment
Benefits:
- Employees can work remotely
- Equal opportunity employer
- Commitment to operating with integrity, driving innovation, transforming lives and serving the community
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