Clinical Research Associate II - Oncology (Central Tennessee)

AbbVie•Nashville, TN

1d•$78,500 - $141,000

About The Position

The Clinical Research Associate II advances AbbVie’s clinical research pipeline by supporting high-quality clinical trials and helping translate scientific research into medicine. The role partners with investigators and site staff to build effective, trusted relationships and position AbbVie as a preferred clinical-trial partner. It focuses on site-level trial conduct, data integrity, regulatory compliance, study performance, patient safety, recruitment and retention, and the overall site experience. The CRA II serves as the primary contact for investigative sites and conducts site evaluation, training, routine monitoring, and site closure activities. The role applies protocol and monitoring plans, applicable regulations, Good Clinical Practice (GCP), ICH Guidelines, AbbVie SOPs, and quality standards. It develops site-engagement strategies, uses site insights and CRM tools to track progress, assesses site risk with Central Monitoring, and works with sites on preventive and corrective actions. The position also supports investigator and site selection, timely and accurate data and safety-event reporting, inspection readiness, and investigator payments where applicable. The CRA II may mentor less experienced CRAs and contribute to task forces and other initiatives.

Requirements

At least 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 and onsite and offsite monitoring.
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 and efficiently in a dynamic environment with competing projects and deadlines.
Ability to leverage technology, tools, and resources to provide customer-centric support based on site health.
Strong interpersonal skills and excellent written, verbal, active-listening, and presentation skills; ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
Ability to apply functional expertise, critical thinking, and good judgment to address clinical-site issues.
Integrity and conduct consistent with AbbVie’s code of business conduct and leadership values.
Self-motivation and focus on delivering timely, high-quality outcomes in a fast-paced environment.

Nice To Haves

Tertiary qualification in a health-related discipline such as medical, scientific, or nursing.
Knowledge of relevant therapeutic-area indications and the ability to understand and apply scientific concepts to clinical-trial conduct.

Responsibilities

Serve as the primary point of contact for investigative sites and provide contextual information about clinical trials.
Align, train, and motivate site staff and principal investigators on trial-program goals, protocols, and patient-treatment principles.
Conduct site evaluation, site training, routine monitoring, and site closure monitoring in accordance with protocols, monitoring plans, regulations, GCP, ICH Guidelines, AbbVie SOPs, and quality standards.
Customize site-engagement strategies, gather local and site insights, and use CRM and other engagement tools to track progress and measure impact.
Connect protocol and scientific principles to day-to-day trial execution and evaluate recruitment and retention techniques based on the patient disease journey.
Build therapeutic-area, asset, clinical-landscape, and patient-journey knowledge to support patient recruitment and protocol compliance.
Mentor and train less experienced CRAs and provide input into their development.
Participate in global or local task forces and initiatives, and complete activities assigned by the manager.
Conduct ongoing risk assessment with the Central Monitoring team to identify study-performance or patient-safety issues at clinical sites.
Resolve site risk signals, and ensure preventive and corrective action plans are implemented as needed to mitigate risk and promote compliance.
Identify, evaluate, and recommend potential investigators and sites for planned clinical studies.
Ensure the quality and timely submission of site data, including appropriate reporting and follow-up of safety events by site personnel.
Maintain audit and regulatory inspection readiness at assigned clinical sites.
Manage investigator payments in accordance with executed contract obligations, as applicable.