Clinical Research Associate II – Oncology

This is a fully remote position, open to applicants in New York.

📋 Description

• Propel AbbVie’s oncology clinical research initiatives and transform scientific discoveries into therapeutic solutions.

• Act as the main liaison for investigative sites.

• Offer contextual insights regarding clinical trials and facilitate connections between stakeholders and investigative sites.

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

• Perform site evaluations, provide site training, conduct routine monitoring, and manage site closure activities.

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

• Design and tailor site engagement strategies.

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

• Assess recruitment and retention strategies based on patient disease trajectories.

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

• Mentor and train less experienced Clinical Research Associates (CRAs).

• Engage in global or local task forces and initiatives.

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

• Address site risk signals and execute preventative and corrective action plans.

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

• Ensure data integrity, timely data submission, safety-event reporting, and follow-up.

• Maintain readiness for audits and regulatory inspections.

• Oversee investigator payments when applicable.

⛳️ Requirements

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

• Minimum of 1 year of clinically related experience.

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

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

• Knowledge of therapeutic area indications is preferred.

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

• Exceptional cross-functional collaboration skills.

• Strong planning and organizational abilities; adept at managing competing projects and deadlines.

• Capability to leverage technology, tools, and resources effectively.

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

• Ability to forge site relationships and trusted partnerships through engagement, motivation, and training.

• Critical thinking and judgment skills to resolve clinical site challenges.

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

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

• Willingness to travel 75% of the time.

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Equal opportunity employer.

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