Clinical Research Associate II – Oncology

This is a fully remote position, open to applicants in District of Columbia, +2 more states.

📋 Description

• Propel AbbVie’s oncology clinical research pipeline by ensuring excellence in clinical research.

• Act as the main contact for investigative sites.

• Provide relevant information regarding clinical trials and facilitate connections between stakeholders and investigative sites.

• Align, educate, and inspire site personnel and principal investigators on trial objectives, protocols, and patient treatment principles.

• Perform site evaluations, training, routine monitoring, and closure assessments.

• Ensure adherence to protocols, monitoring plans, regulations, Good Clinical Practices, ICH Guidelines, AbbVie SOPs, and quality standards.

• Create and tailor strategies for site engagement.

• Collect local and site insights and utilize CRM tools to track progress and assess impact.

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

• Build knowledge in therapeutic areas, assets, clinical landscapes, and patient journeys to enhance recruitment and ensure protocol compliance.

• Guide and mentor less experienced Clinical Research Associates (CRAs).

• Take part in global or local task forces and initiatives.

• Conduct ongoing risk assessments in collaboration with the Central Monitoring team.

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

• Identify, assess, and recommend investigators and clinical sites.

• Guarantee the quality and timely submission of site data and safety-event reports.

• Maintain readiness for audits and regulatory inspections.

• Manage investigator payments as per executed contracts, where applicable.

⛳️ Requirements

• Relevant tertiary qualification in health-related fields (Medical, Scientific, Nursing) is preferred.

• At least 1 year of clinically related experience is required.

• Minimum of 6 months of experience in clinical research monitoring involving investigational drug or device trials.

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

• Preferred knowledge of relevant therapeutic area indications.

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

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational abilities.

• Capability to thrive in a dynamic environment with competing projects and deadlines.

• Proficiency in utilizing technology, tools, and resources for customer-focused site support.

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

• Ability to establish and leverage relationships with sites and build trusted partnerships.

• Capacity to apply critical thinking and sound judgment to clinical site challenges.

• Integrity in alignment with AbbVie’s code of business conduct and leadership values.

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

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Eligibility for remote work.

• Equal opportunity employment.

• Reasonable accommodations for applicants with disabilities.