Clinical Research Associate II – Dermatology

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

📋 Description

• Propel AbbVie’s clinical research initiatives and aid in the creation of groundbreaking medicines and solutions.

• Act as the main liaison for investigative sites.

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

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

• Perform site evaluations, site training, regular monitoring, and site closure assessments.

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

• Tailor site engagement strategies for assigned studies.

• Collect local and site insights and utilize CRM tools to track progress and assess impact.

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

• Assess and ensure 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 and provide input on their development.

• Engage in global or local task forces and initiatives.

• Conduct ongoing risk assessments with the Central Monitoring team.

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

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

• Identify, assess, and recommend investigators and sites.

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

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

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

⛳️ Requirements

• A minimum of 1 year of experience in a clinically related field.

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

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

• Preferred knowledge of therapeutic area indications.

• 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.

• Capability to perform effectively 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.

• Ability to build and leverage relationships and partnerships with sites.

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

• Integrity in accordance with AbbVie’s code of business conduct and leadership values.

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

• Preferred qualifications include an appropriate tertiary degree in health-related disciplines (Medical, Scientific, Nursing).

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) plan.

• Short-term incentive programs.

• Travel opportunities (approximately 75% of the time).

• Commitment to equal opportunity employment and reasonable accommodation support.