Clinical Research Associate II - Oncology NY State

About the role

Advance AbbVie’s pipeline by striving for excellence in clinical research, turning science into medicine for patients and leveraging new advanced capabilities to drive industry-leading performance. Partner with investigators and site staff for meaningful and effective engagements that position AbbVie as the preferred choice for clinical trials. Focus on site-level clinical research that ensures appropriate trial conduct while improving data integrity, compliance, overall study performance and customer experience.

Responsibilities

• Serve as the primary point of contact for investigative sites.
• Provide high-level contextual information on clinical trials, connect stakeholders to sites, and strengthen AbbVie’s positioning.
• Align, train and motivate site staff and principal investigators on trial goals, protocol and patient treatment principles to ensure a trusted partnership.
• Conduct site evaluation, site training, routine monitoring and site closure activities in compliance with protocol, monitoring plans, applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs and quality standards, ensuring subject safety and protection.
• Apply advanced understanding of site engagement and customize site engagement strategies for assigned studies; gather local insights and use CRM tools to report progress and measure impact.
• Translate study protocol, scientific principles and clinical trial requirements into day-to-day execution activities; evaluate and ensure effective recruitment and retention plans aligned with the patient disease journey.
• Develop in-depth knowledge of therapeutic area, asset and clinical landscape/patient journey to enable successful recruitment and protocol compliance.
• Mentor less experienced CRAs and provide input into their development; may participate in global or local task forces and initiatives.
• Proactively perform continuous risk assessment and, with the Central Monitoring team, monitor site activities to detect early performance or patient safety issues; implement preventative and corrective action plans as needed using a customer-centric approach.
• Identify, evaluate and recommend new or potential investigators/sites on an ongoing basis, including through networking and internal AbbVie requests.
• Ensure quality of data submitted by sites and timely submission, including appropriate reporting and follow-up for all safety events; maintain audit and regulatory inspection readiness at assigned sites; manage investigator payments per executed contract obligations as applicable.

Qualifications

• Appropriate tertiary qualification in a health-related discipline (Medical, Scientific, Nursing) preferred.
• Minimum of 1 year of clinically related experience, including at least 6 months in clinical research monitoring of investigational drug or device trials.
• Familiarity with risk-based monitoring approaches, both onsite and offsite.
• Knowledge of relevant therapeutic area indications preferred, with ability to understand and apply scientific concepts to trial conduct.
• Advanced knowledge of existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
• Strong cross-functional collaboration skills among internal and external stakeholders.
• Strong planning and organizational skills with the ability to work effectively in a dynamic environment with competing projects and deadlines.
• Advanced ability to leverage technology, tools and resources to provide customer-centric support based on site health.
• Excellent interpersonal, written, verbal, active listening and presentation skills; ability to establish and leverage site relationships and trusted partnerships through engagement, motivation and training.
• Ability to exercise functional expertise with appropriate guidance, leverage critical thinking and apply good judgment to address site issues; acts with integrity in accordance with AbbVie’s code of business conduct and leadership values.