Clinical Research Associate II – Oncology

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

📋 Description

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

• Provide detailed information regarding clinical trials and facilitate connections between stakeholders and investigative sites.

• Align, educate, and inspire site personnel and principal investigators on the objectives of clinical trials, protocols, and principles of patient treatment.

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

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

• Create and tailor site engagement strategies for designated studies.

• Collect local insights and site data, utilizing CRM tools to track progress and assess impact.

• Facilitate the execution of clinical trials by linking protocols, scientific principles, and trial requirements to everyday activities.

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

• Build knowledge in therapeutic areas, assets, clinical landscapes, and patient journeys to enhance recruitment and ensure protocol compliance.

• 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.

• Oversee site activities to identify any performance or patient safety concerns.

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

• Identify and assess potential investigators and sites.

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

• Maintain readiness for audits and regulatory inspections.

• Manage investigator payments in accordance with executed contract obligations, as applicable.

⛳️ Requirements

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

• A minimum of 1 year of experience in clinically related roles.

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

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

• Preferred knowledge of relevant therapeutic area indications.

• Advanced understanding of local regulatory and legal standards, ICH/GCP Guidelines, and applicable policies.

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational capabilities.

• Ability to thrive in a dynamic environment with competing projects and deadlines.

• Proficiency in leveraging technology, tools, and resources.

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

• Capability to establish relationships and build trusted partnerships with sites.

• Critical thinking skills and sound judgment to resolve clinical site issues.

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

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

• Ability to work remotely within the United States.

🏝️ Benefits

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

• Comprehensive medical, dental, and vision insurance.

• 401(k) retirement plan.

• Short-term incentive programs.

• Equal opportunity employer benefits and accommodations.