Clinical Research Associate II – Dermatology

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

📋 Description

• Propel AbbVie’s clinical research initiatives and contribute to the development of innovative medicines and solutions.

• Act as the main liaison for investigative sites.

• Offer contextual details regarding clinical trials and facilitate connections between stakeholders and investigative sites.

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

• Perform site evaluations, training, routine monitoring, and site closure tasks.

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

• Create and tailor site engagement strategies.

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

• Assist in the execution of clinical trials and ensure protocol compliance.

• Assess recruitment and retention strategies in relation to the patient disease journey.

• Acquire knowledge of the therapeutic area, clinical asset, clinical landscape, and patient journey.

• Mentor and train junior CRAs.

• Engage in global or local task forces and initiatives.

• Conduct ongoing risk assessments with the Central Monitoring team.

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

• Identify, evaluate, and recommend investigators and clinical trial sites.

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

• Maintain readiness for audits and regulatory inspections.

• Oversee investigator payments in accordance with executed contract obligations.

⛳️ Requirements

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

• At least 1 year of experience in a clinically related role.

• Minimum of 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 therapeutic area indications.

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

• Excellent cross-functional collaboration skills.

• Strong planning and organizational abilities.

• Capability to work efficiently in a dynamic environment with competing projects and deadlines.

• Advanced ability to utilize technology, tools, and resources effectively.

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

• Ability to build and maintain site relationships and trusted partnerships.

• Capacity to apply functional expertise, critical thinking, and sound judgment in addressing clinical site issues.

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

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

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) plan.

• Eligibility to participate in short-term incentive programs.