AbbVie: Clinical Research Associate (CRA) - Pittsburg & Michigan

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

About the Role

Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging new advanced capabilities to drive industry-leading performance. This role partners with the investigator and site staff for meaningful and effective engagements, positioning AbbVie as the preferred choice in clinical trials. The focus is on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance, and customer experience.

Responsibilities

• Serve as the primary point of contact for the investigative site, providing contextual information on clinical trials and strengthening AbbVie's positioning.
• Align, train, and motivate site staff and the principal investigator on clinical trial program goals, protocol, and patient treatment principles, fostering a trusted partnership.
• Conduct site evaluation, training, routine monitoring, and site closure activities in compliance with protocols, monitoring plans, regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring the safety and protection of study subjects.
• Develop and implement customized site engagement strategies for assigned studies, gathering local insights and utilizing tools like the Customer Relationship Management (CRM) tool to track progress and measure impact.
• Evaluate and ensure effective patient recruitment and retention techniques based on the patient disease journey, demonstrating an advanced understanding of the study protocol, scientific principles, and clinical trial requirements.
• Mentor and train less experienced CRAs and provide input into their development.
• Participate in global/local task forces and initiatives as assigned by management.
• Conduct continuous risk assessment and collaborate with the Central Monitoring team to monitor site activities, proactively identifying and mitigating study performance or patient safety issues.
• Utilize critical thinking to resolve site risk signals and drive study execution, ensuring preventative and corrective action plans are implemented to mitigate risk and promote compliance with a customer-centric approach.
• Identify, evaluate, and recommend potential new investigators/sites.
• Ensure the quality of data submitted from study sites and timely submission of data, including appropriate reporting and follow-up for all safety events.
• Maintain audit and regulatory inspection readiness at assigned clinical sites.
• Manage investigator payments as per executed contract obligations.

Qualifications

• Appropriate tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) is 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, including onsite and offsite monitoring.
• Knowledge of appropriate therapeutic area indications is preferred, with the ability to understand and apply scientific concepts to clinical trial conduct.
• Advanced knowledge of existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.
• Strong cross-functional collaboration skills with 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.
• Strong interpersonal skills, including excellent written, verbal, active listening, and presentation skills, with the ability to establish and leverage trusted site relationships through engagement, motivation, and training.
• Ability to apply functional expertise, critical thinking, and good judgment to address clinical site issues.
• Demonstrated integrity in accordance with AbbVie's code of business conduct and leadership values.
• Self-motivated with a focus on delivering timely and quality outcomes in a fast-paced environment.

Benefits

• Comprehensive package including paid time off (vacation, holidays, sick).
• Medical/dental/vision insurance.
• 401(k) plan.
• Eligibility to participate in short-term incentive programs.

Additional Information

• Compensation range will be disclosed based on job grade, geographic location, and other factors.
• AbbVie is an equal opportunity employer. For more information, visit AbbVie's Equal Employment Opportunity page.
• Information on reasonable accommodations for US & Puerto Rico applicants is available. Learn More