Clinical Research Associate II - Oncology (Remote US - Multiple Openings)

Clinical Research Associate (CRA)

About AbbVie:
AbbVie's mission is to discover and deliver innovative medicines and solutions that address serious health issues today and tackle tomorrow's medical challenges. We aim to have a remarkable impact on people's lives across key therapeutic areas including immunology, oncology, and neuroscience, as well as through our Allergan Aesthetics portfolio.

Job Description:
We are hiring Clinical Research Associates in Boston, Pittsburgh, and Michigan. This role advances AbbVie's pipeline by driving excellence in clinical research, translating science into medicine, and leveraging advanced capabilities for industry-leading performance. You will partner with investigators and site staff for effective engagement, positioning AbbVie as the preferred partner in clinical trials.

Your focus will be on site clinical research, ensuring trial conduct aligns with protocol requirements while improving data integrity, compliance, study performance, and customer experience.

Responsibilities:

• Serve as the primary point of contact for investigative sites, providing contextual trial information and strengthening AbbVie's positioning.
• Align, train, and motivate site staff and principal investigators on clinical trial program goals, protocols, and patient treatment principles.
• Conduct site evaluations, training, routine monitoring, and closure activities in compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, and AbbVie SOPs.
• Develop advanced site engagement strategies tailored to assigned studies, gathering local insights and utilizing CRM tools.
• Connect study protocols, scientific principles, and clinical trial requirements to daily execution activities.
• Evaluate and ensure effective patient recruitment and retention techniques based on the patient disease journey.
• Develop strong knowledge of the therapeutic area, asset, and clinical landscape to support patient recruitment and protocol compliance.
• Mentor and train less experienced CRAs and provide input into their development.
• May participate in global/local task forces and initiatives.
• Conduct continuous risk assessment and collaborate with Central Monitoring to detect study performance or patient safety issues.
• Critically resolve site risk signals, understanding site processes to drive study execution and implement preventative/corrective actions.
• Identify, evaluate, and recommend new/potential investigators/sites.
• Ensure data quality from study sites and timely submission of data, including reporting and follow-up for all safety events.
• Ensure audit and regulatory inspection readiness at assigned clinical sites.
• Manage investigator payments as per executed contract obligations.

Qualifications:

• Tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred.
• Minimum of 1 year of clinically related experience, with at least 6 months in clinical research monitoring of investigational drug or device trials.
• Familiarity with risk-based monitoring approaches (on-site and off-site).
• Knowledge of appropriate therapeutic area indications is preferred.
• Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.
• Strong cross-functional collaboration skills.
• Strong planning and organizational skills, with the ability to work effectively in a dynamic environment.
• Advanced ability to leverage technology and tools for customer-centric support.
• Strong interpersonal skills with excellent written, verbal, listening, and presentation skills.
• Ability to use functional expertise, critical thinking, and good judgment to address clinical site issues.
• Acts with integrity in accordance with AbbVie's code of business conduct and leadership values.

Additional Information:

• This job is eligible for short-term incentive programs.
• Comprehensive benefits package including paid time off, medical/dental/vision insurance, and 401(k) for eligible employees.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving our community.