Clinical Research Associate
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Job Description
Clinical Research Associate advancing AbbVie’s innovative oncology medicines pipeline. Monitoring investigative sites, ensuring compliance, data integrity, patient safety, and recruitment performance.
Responsibilities:
- Advance AbbVie’s clinical development pipeline through excellence in clinical research
- Partner with investigators and site staff to establish meaningful and effective clinical-trial engagements
- Serve as the primary 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
- Conduct site evaluation, site training, routine monitoring, and site-closure monitoring in compliance with protocols, regulations, GCP, ICH Guidelines, AbbVie SOPs, and quality standards
- Customize site-engagement strategies for assigned studies
- Gather local and site insights and use CRM tools to track progress and measure impact
- Connect study protocols, scientific principles, and clinical-trial requirements to day-to-day execution
- Evaluate recruitment and retention techniques based on the patient disease journey
- Develop therapeutic-area, asset, clinical-landscape, and patient-journey knowledge to support recruitment and protocol compliance
- Mentor and train less experienced CRAs and provide development input
- Participate in global or local task forces and initiatives
- Perform manager-assigned activities
- 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 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 contracts, where applicable
Requirements:
- Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred
- Minimum of 1 year of clinically related experience
- At least 6 months of clinical research monitoring experience for investigational drug or device trials
- Familiarity with risk-based monitoring, onsite and offsite monitoring
- Knowledge of therapeutic area indications preferred
- Ability to understand and apply scientific concepts to clinical trial conduct
- Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
- Strong cross-functional collaboration skills
- Strong planning and organizational skills; ability to work effectively in a dynamic environment with competing projects and deadlines
- Advanced ability to leverage technology, tools, and resources for customer-centric site support
- Strong interpersonal skills and 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 use functional expertise, critical thinking, and good judgment to address clinical site issues
- Acts with 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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