Clinical Research Associate II - Oncology

ICompany Description

Abb Vie'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 - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on X, Facebook, Instagram, You Tube, Linked In and Tik Tok.

Key Responsibilities:

• Considered as the primary Sponsor point of contact for the investigative site. High level of competency or experience in providing contextual information on the clinical trials, connects stakeholders to the investigative sites and strengthens Abb Vie's positioning.
• Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership.
• Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance with the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, Abb Vie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects.
• 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 to report/track progress and measure impact of that strategy.
• “Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. Evaluate and ensure effective recruitment and retention techniques/plans based on the patient's disease journey.”
• Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
• Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development.
• May participate in global/local task forces and initiatives. Responsible for activities assigned by manager.
• Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
• Identifies, evaluates and recommends new/potential investigators/sites on an ongoing basis. Potential sites may be identified through networking or internal Abb Vie requests to assist in the placement of planned clinical studies with qualified investigators.
• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
• Ensures audit and regulatory inspection readiness at always assigned clinical site.
• Manages investigator payments as per executed contract obligations, as applicable.

Requirements:

• Education:
  
  Bachelor's degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy).
• 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 with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
• Advanced knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable…