Clinical Research Associate II – Oncology

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

📋 Description

• Act as the main point of contact for investigative sites.

• Supply contextual information regarding clinical trials and facilitate connections between stakeholders and investigative sites.

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

• Perform site evaluations, training, routine monitoring, and site closure monitoring in accordance with protocols, regulations, GCP, ICH Guidelines, SOPs, and quality standards.

• Create and tailor site engagement strategies for designated studies.

• Collect local and site-specific insights while utilizing CRM tools to monitor progress and assess impact.

• Link study protocols and scientific principles to the daily execution of clinical trials.

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

• Mentor and train less-experienced CRAs, contributing to their professional development.

• Engage in global or local task forces and initiatives.

• Conduct ongoing risk assessments with the Central Monitoring team to identify issues related to study performance or patient safety.

• Execute preventative and corrective action plans to mitigate risks and ensure compliance.

• Identify, evaluate, and recommend investigators and sites for upcoming clinical studies.

• Ensure the quality and prompt submission of site data, including safety event reporting and follow-ups.

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

• Manage investigator payments as per the terms of executed contracts, when applicable.

⛳️ Requirements

• A minimum of 1 year of clinically related experience.

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

• Familiarity with risk-based monitoring as well as onsite and offsite monitoring.

• Preferred knowledge of relevant therapeutic area indications.

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

• Strong skills in cross-functional collaboration.

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

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

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

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

• Capability to apply critical thinking and sound judgment to clinical site issues.

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

• A self-motivated approach with a focus on timely, quality results.

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

• Willingness and capacity to travel 75% of the time.

🏝️ Benefits

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

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Option for remote work arrangements.

• Equal opportunity employer.

• Reasonable accommodations available for US & Puerto Rico applicants.