Clinical Research Associate II – Oncology

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

📋 Description

• Propel AbbVie’s clinical research pipeline and convert scientific advancements into therapeutic 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, educate, and inspire site personnel and principal investigators regarding trial objectives, protocols, and patient-treatment principles.

• Conduct evaluations of sites, provide training, perform routine monitoring, and oversee site closure activities.

• Ensure adherence to protocols, monitoring strategies, regulations, GCP, ICH Guidelines, AbbVie SOPs, and quality benchmarks.

• Tailor site engagement strategies and monitor progress utilizing CRM tools.

• Assist in the execution of clinical trials by linking protocols, scientific principles, and trial requirements to everyday operations.

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

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

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

• Engage in global and 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 strategies.

• Identify, evaluate, and propose investigators and sites for clinical studies.

• Guarantee prompt and precise site data submissions along with appropriate safety-event reporting and follow-up.

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

• Oversee investigator payments according to executed contracts, as 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.

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

• Preferred knowledge of relevant therapeutic area indications.

• Capability to comprehend and apply scientific concepts in the execution of clinical trials.

• 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; adept at managing multiple projects and deadlines.

• Advanced proficiency in utilizing technology, tools, and resources.

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

• Skill in establishing site relationships and fostering trusted partnerships through engagement, motivation, and training.

• Ability to apply critical thinking and sound judgment to issues at clinical sites.

• Commitment to acting with integrity according to AbbVie’s code of business conduct and leadership values.

• Self-driven and focused on achieving timely, quality results in a dynamic environment.

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) retirement plan.

• Eligibility to participate in short-term incentive programs.

• Equal opportunity employer.

• Reasonable accommodation support for applicants with disabilities.