Clinical Research Associate II – Dermatology

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

📋 Description

• Act as the main point of contact for the investigative site

• Provide relevant 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 patient treatment principles

• Perform site evaluations, training sessions, routine monitoring, and closure activities

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

• Tailor site engagement strategies for designated studies

• Collect site insights and utilize CRM tools to monitor progress and assess impact

• Analyze recruitment and retention strategies based on patient disease journeys

• Cultivate knowledge in therapeutic areas, assets, clinical landscapes, and patient journeys to aid in recruitment and protocol adherence

• Mentor and guide less experienced Clinical Research Associates (CRAs)

• Engage in global/local task forces and initiatives

• Conduct ongoing risk assessments with the Central Monitoring team

• Address site risk indicators and implement proactive and corrective action plans

• Identify, assess, and recommend investigators and clinical trial sites

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

• Maintain readiness for audits and regulatory inspections

• Manage investigator payments as necessary

⛳️ Requirements

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

• At least 1 year of experience in clinically related roles

• Minimum of 6 months of experience in clinical research monitoring for investigational drug or device trials

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

• Preferred knowledge of therapeutic area indications

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

• Excellent cross-functional collaboration abilities

• Strong planning and organizational capabilities

• Ability to work efficiently in a fast-paced environment with multiple projects and deadlines

• Advanced skills in utilizing technology, tools, and resources

• Strong interpersonal, written, verbal, active listening, and presentation abilities

• Capability to build and maintain site relationships and trusted partnerships

• Capacity to apply critical thinking and sound judgment to clinical site challenges

• Integrity consistent with AbbVie’s code of business conduct and leadership principles

• Self-driven focus on achieving timely and quality results

🏝️ Benefits

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

• Medical, dental, and vision insurance

• 401(k) plan

• Short-term incentive programs

• 75% travel compensation for role participation