Senior Clinical Research Associate
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Job Description
Senior Clinical Research Associate overseeing clinical trial sites for AbbVie, an innovative medicines company. Managing monitoring, compliance, recruitment, risk assessment and site partnerships.
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, applicable regulations, GCP, ICH Guidelines, AbbVie SOPs and quality standards
- Customize site engagement strategies and track progress, impact and local/site insights
- Apply scientific principles, clinical trial requirements and therapeutic-area knowledge to 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
- Conduct continuous risk assessment with the Central Monitoring team to detect study performance or patient safety issues
- Resolve site risk signals and implement preventative and corrective action plans
- Identify, evaluate and recommend investigators and sites for clinical studies
- Ensure quality and timely submission of site data, including safety-event reporting and follow-up
- Maintain audit and regulatory inspection readiness at assigned sites
- Manage investigator payments according to executed contract obligations, as applicable
- Perform additional activities assigned by the manager
Requirements:
- Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred
- Minimum of 3 years of clinically related experience
- Preferably 2 years of 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 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
- 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
- Excellent 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 judgment
- Acts with integrity in accordance with AbbVie code of business conduct and leadership values
- Self-motivated and focused on timely, quality outcomes
- Full-time availability
Benefits:
- Equal opportunity employer
- Commitment to operating with integrity, driving innovation, transforming lives and serving the community
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