Clinical Research Associate II – Oncology

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

📋 Description

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

• Act as the main liaison for investigative sites.

• Offer contextual insights on clinical trials and connect stakeholders with investigative sites.

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

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

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

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

• Facilitate clinical trial execution, patient recruitment, retention, and adherence to protocols.

• Mentor and train less experienced Clinical Research Associates (CRAs) and contribute to their professional development.

• Engage in global or local task forces and initiatives.

• Conduct ongoing risk assessments with the Central Monitoring team to pinpoint study performance and patient safety concerns.

• Develop and implement preventive and corrective action plans to mitigate risks and enhance compliance.

• Identify, evaluate, and propose investigators and clinical trial sites.

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

• Maintain readiness for audits and regulatory inspections at designated sites.

• Manage investigator payments in accordance with executed contracts, where applicable.

⛳️ Requirements

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

• A minimum of 1 year of clinically related experience is required.

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

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

• Knowledge of therapeutic area indications is preferred.

• Understanding of local regulatory and legal frameworks, ICH/GCP Guidelines, and applicable policies.

• Excellent cross-functional collaboration skills.

• Strong planning and organizational capabilities.

• Ability to operate effectively in a dynamic environment with competing priorities and deadlines.

• Proficient in leveraging technology, tools, and resources for customer-focused site support.

• Exceptional interpersonal, written, verbal, active listening, and presentation abilities.

• Capacity to build site relationships and establish trusted partnerships through engagement, motivation, and training.

• Critical thinking and sound judgment to address issues at clinical sites.

• Commitment to act with integrity in line with AbbVie’s code of business conduct and leadership values.

• Self-driven and focused on achieving timely, quality outcomes in a fast-paced setting.

🏝️ Benefits

• Paid time off, including vacation, holidays, and sick leave.

• Comprehensive medical, dental, and vision insurance.

• 401(k) retirement plan.

• Eligibility to participate in short-term incentive programs.