Clinical Research Associate
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Job Description
Field-based Clinical Research Associate advancing AbbVie’s innovative medicines through clinical trials. Monitoring sites, ensuring compliance, and supporting patient recruitment and data integrity.
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, GCPs, ICH Guidelines, SOPs, and quality standards
- Customize site engagement strategies and track their progress and impact
- Gather local and site insights
- Connect study protocols and scientific principles to day-to-day trial execution
- Develop and ensure effective patient recruitment and retention techniques and plans
- Build therapeutic-area, asset, clinical-landscape, and patient-journey knowledge to support recruitment and protocol compliance
- Participate in or lead global and local task forces and initiatives
- Conduct continuous risk assessment with the Central Monitoring team
- Identify and resolve site risk signals and implement preventative and corrective action plans
- Identify, evaluate, and recommend investigators and sites for planned 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
Requirements:
- Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred or experience
- Independent clinical research monitoring experience of investigational drug or device trials in any therapeutic area
- 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 existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
- Advanced communication skills and superior cross-functional collaboration skills
- Strong planning and organizational skills; ability to work effectively 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 through engagement, motivation, and training
- Ability to independently use functional expertise, critical thinking, and good judgment to address clinical site issues
- Integrity in accordance with AbbVie code of business conduct and leadership values
- Self-motivated approach focused on timely, quality outcomes in a fast-paced environment
Benefits:
- Excellent development opportunities
- Reward and benefits package
- Large car park for easy access
- Step-free entry, accessible restrooms, and elevators
- Assistive technologies and adaptable workstations
- Dedicated quiet zone
- Equal opportunity employer committed to accessibility and employee well-being
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