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

Purpose:
- Advance the clinical research pipeline by striving for excellence in clinical research and leveraging advanced capabilities to drive industry-leading performance.
- Partner with investigators and site staff for meaningful engagements in clinical trials.
- Ensure appropriate trial conduct while improving data integrity, compliance, overall study performance, and customer experience.

Responsibilities:
- Serve as primary point of contact for investigative sites; provide contextual clinical trial information and strengthen AbbVie’s positioning.
- Align, train, and motivate site staff and principal investigator on trial goals, protocol, and patient treatment principles.
- Conduct site evaluation, training, routine monitoring, and site closure monitoring in compliance with the protocol, monitoring plans, applicable regulations, GCP, ICH guidelines, AbbVie SOPs, and quality standards to ensure participant safety and protection.
- Customize site engagement strategy for assigned study(ies); use site insights and tools (e.g., CRM) to track progress and measure impact.
- Connect protocol/scientific principles to day-to-day execution; evaluate recruitment and retention techniques based on patient disease journey; develop therapeutic area/asset/clinical landscape knowledge for recruitment and protocol compliance.
- Mentor and train less experienced CRAs; provide input to their development; may participate in task forces/initiatives; perform activities assigned by manager.
- Proactively conduct continuous risk assessment; collaborate with Central Monitoring to detect early performance and/or patient safety issues.
- Resolve site risk signals critically; ensure preventative/corrective action plans are implemented to mitigate risk and promote compliance.
- Identify, evaluate, and recommend new/potential investigators/sites on an ongoing basis.
- Ensure quality and timely submission of site data, including safety event reporting/follow-up; maintain audit and regulatory inspection readiness; manage investigator payments per executed contracts (as applicable).

Qualifications:
- Education: Bachelor’s degree or equivalent; health-related preferred (e.g., Medical, Scientific, Nursing, Pharmacy).
- Minimum 1 year clinically related experience; includes 6 months in clinical research monitoring of investigational drug/device trials; familiar with risk-based monitoring and onsite/offsite monitoring.
- Preferred: knowledge of therapeutic area indications and ability to apply scientific concepts to clinical trial conduct.
- Advanced knowledge of local regulatory/legal requirements, ICH/GCP guidelines, and applicable policies.
- Strong cross-functional collaboration.
- Strong planning/organizational skills in a dynamic environment with competing deadlines.
- Advanced ability to leverage technology/tools/resources for customer-centric site support.
- Strong interpersonal skills; excellent written/verbal communication, active listening, and presentation skills; ability to build trusted site relationships through engagement, motivation, and training.
- Ability to use functional expertise with guidance; apply critical thinking and good judgment to address clinical site issues.
- Integrity and alignment with code of business conduct and leadership values; self-motivated with focus on timely, quality outcomes.

Location/Travel:
- Field based/remote in CA, WA, OR, IA, MN, IN, OH, FL; must reside in one of these states and be willing to travel for site visits.