Clinical Research Associate II – Oncology

This is a fully remote position, open to applicants in Kentucky, +1 more state.

📋 Description

• Propel AbbVie’s clinical development pipeline by achieving excellence in clinical research.

• Act as the primary liaison for investigative sites.

• Provide context for clinical trials and facilitate connections between stakeholders and investigative sites.

• Align, train, and inspire site staff and principal investigators regarding trial objectives, protocols, and patient treatment principles.

• Conduct evaluations of sites, provide training, perform routine monitoring, and carry out site closure activities.

• Ensure adherence to protocols, monitoring plans, regulations, GCPs, ICH Guidelines, SOPs, and quality standards.

• Develop and tailor strategies for site engagement.

• Collect insights from sites and utilize CRM tools to monitor progress and assess impact.

• Assist in the execution of clinical trials by linking protocols and scientific principles to daily operations.

• Assess recruitment and retention strategies based on the patient disease journey.

• Cultivate knowledge in therapeutic areas, assets, the clinical landscape, and patient journeys.

• Mentor and train junior CRAs, offering developmental feedback.

• Engage in global or local task forces and initiatives.

• Perform continuous risk assessments in collaboration with the Central Monitoring team.

• Address site risk signals and implement preventive and corrective action plans.

• Identify and evaluate prospective investigators and sites.

• Ensure data quality, timely data submissions, safety-event reporting, and follow-ups.

• Maintain readiness for audits and regulatory inspections.

• Oversee investigator payments in accordance with contractual obligations, where applicable.

⛳️ Requirements

• A minimum of 1 year of experience in a clinically related field.

• At least 6 months of clinical research monitoring experience in investigational drug or device trials.

• Familiarity with risk-based monitoring, including both onsite and offsite monitoring.

• Preferred knowledge of therapeutic area indications.

• Advanced understanding of local regulatory and legal requirements, ICH/GCP Guidelines, and relevant policies.

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational abilities.

• Capacity to work effectively in a fast-paced environment with competing projects and deadlines.

• Ability to utilize technology, tools, and resources effectively.

• Strong interpersonal, written, verbal, active listening, and presentation skills.

• Capability to build site relationships and establish trusted partnerships.

• Critical thinking and sound judgment to tackle clinical site challenges.

• Integrity that aligns with AbbVie’s code of business conduct and leadership values.

• Self-motivated and focused on achieving timely, high-quality outcomes.

• Preferred tertiary qualification in a health-related discipline (Medical, Scientific, Nursing).

🏝️ Benefits

• Paid time off (vacation, holidays, sick leave).

• Medical, dental, and vision insurance coverage.

• 401(k) retirement plan.

• Eligibility for short-term incentive programs.

• Equal opportunity employer.

• Reasonable accommodations for applicants in the US and Puerto Rico.