Clinical Research Associate II – Oncology

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

📋 Description

• Propel AbbVie’s clinical research initiatives and assist in transforming scientific advancements into medical solutions for patients.

• 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 inspire site personnel and principal investigators on trial objectives, protocols, and patient treatment guidelines.

• Execute site evaluations, training, routine monitoring, and closure in adherence to protocols, regulations, GCP, ICH Guidelines, SOPs, and quality benchmarks.

• Tailor site engagement strategies and utilize CRM tools to monitor progress and assess impact.

• Assist in the daily execution of clinical trials by applying knowledge of protocols, scientific principles, and clinical research.

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

• Guide and train junior CRAs, contributing to their professional growth.

• Engage in global/local task forces and initiatives.

• Conduct ongoing risk assessments with the Central Monitoring team and respond to site risk indicators.

• Develop and implement preventative and corrective action plans to reduce risks and enhance compliance.

• Identify and assess potential investigators and clinical trial sites.

• Ensure the quality and prompt submission of site data and safety-event reports.

• Maintain readiness for audits and regulatory inspections.

• Oversee investigator payments where applicable.

⛳️ Requirements

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

• At least 1 year of experience in a clinically related role.

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

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

• Preferred knowledge of relevant therapeutic area indications.

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

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational abilities; capable of managing multiple projects and deadlines.

• Advanced capability to utilize technology, tools, and resources effectively.

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

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

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

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

• Self-driven with a focus on timely and 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 and Puerto Rico.