Clinical Research Associate II - Oncology MD/NJ/DE

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. Partner with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials. Focus 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

• Act as the primary point of contact for the investigative site.
• Provide high-level competency or experience in providing contextual information on clinical trials, connect stakeholders to investigative sites and strengthen AbbVie’s positioning.
• Align, train and motivate site staff and principal investigators on the goals of the clinical trial program, protocol and patient treatment principles, ensuring a trusted partnership.
• Conduct site evaluation, site training, routine and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs) and quality standards, ensuring safety and protection of study subjects.
• Demonstrate an advanced understanding of site engagement and ability to customize site engagement strategy for assigned study(ies). Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool to report/track progress and measure impact of that strategy.
• Apply an advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to day-to-day clinical trial execution activities.
• Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of the therapeutic area, asset and clinical landscape/patient journey to enable successful patient recruitment and overall protocol compliance.
• Possess experienced-level competency to mentor and train less experienced CRAs on various aspects of work and provide input into their development. May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.
• Responsible for continuous risk assessment, proactively monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues, in collaboration with the Central Monitoring team.
• Apply advanced critical thinking to resolve site risk signals while maintaining a robust understanding of site processes to drive study execution. Ensure preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer-centric approach.
• Identify, evaluate and recommend new/potential investigators/sites on an ongoing basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
• Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Ensure audit and regulatory inspection readiness at assigned clinical site at all times.
• Manage investigator payments as per executed contract obligations, as applicable.

Qualifications

• Appropriate tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred.
• Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials.
• Familiar with risk-based monitoring approach, onsite and offsite monitoring.
• Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
• Advanced knowledge of existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
• Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
• Demonstrate strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
• Advanced ability to leverage technology, tools and resources to provide customer-centric support based on the health of the site.
• Strong interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation and training.
• Ability to use functional expertise with appropriate guidance, leverage critical thinking skills and apply good judgment to address clinical site issues.
• Act with integrity in accordance with AbbVie code of business conduct and leadership values.
• Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.