Clinical Research Associate II - Dermatology (Southern California)
About The Position
Advance AbbVie’s clinical research pipeline by striving for excellence in clinical research, turning science into medicine for patients, and using advanced capabilities to drive industry-leading performance. The Clinical Research Associate II partners with investigators and site staff to establish effective engagements and position AbbVie as a preferred clinical-trial partner. The role focuses on site clinical research, ensuring appropriate trial conduct while improving data integrity, compliance, study performance, and customer experience. The role is the primary point of contact for investigative sites and conducts site evaluation, training, routine monitoring, and site closure activities. It supports site engagement, recruitment and retention, protocol compliance, risk assessment, data quality, and patient safety, while maintaining readiness for audits and regulatory inspections. The CRA II may mentor less experienced CRAs and participate in local or global initiatives.
Requirements
- At least 1 year of clinically related experience, including at least 6 months of clinical research monitoring of investigational drug or device trials.
- Familiarity with risk-based monitoring, including onsite and offsite monitoring.
- Advanced knowledge of existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.
- Strong cross-functional collaboration skills with internal and external stakeholders.
- Strong planning and organizational skills, including the ability to work effectively in a dynamic environment with competing projects and deadlines.
- Ability to use technology, tools, and resources to provide customer-centered support based on site health.
- Strong interpersonal, written, verbal, active-listening, and presentation skills, with the ability to establish site relationships and trusted partnerships through engagement, motivation, and training.
- Ability to use functional expertise, critical thinking, and sound judgment to address clinical-site issues.
- Integrity in accordance with AbbVie’s code of business conduct and leadership values; self-motivation and focus on timely, quality outcomes in a fast-paced environment.
Nice To Haves
- A tertiary qualification in a health-related discipline, such as medical, scientific, or nursing, is preferred.
- Knowledge of appropriate therapeutic-area indications and the ability to understand and apply scientific concepts to clinical-trial conduct.
Responsibilities
- Serve as the primary point of contact for the investigative site and build effective, trusted relationships with investigators and site staff.
- Provide clinical-trial context and connect stakeholders with investigative sites to support AbbVie’s positioning.
- Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient-treatment principles.
- Conduct site evaluation, training, routine monitoring, and site closure monitoring in compliance with protocols, monitoring plans, regulations, GCP, ICH Guidelines, AbbVie SOPs, and quality standards.
- Customize site engagement strategies for assigned studies; gather site insights and use CRM tools to track progress and measure impact.
- Connect study protocols, scientific principles, and clinical-trial requirements with day-to-day trial execution.
- Evaluate recruitment and retention methods and plans based on the patient disease journey; develop therapeutic-area, asset, clinical-landscape, and patient-journey knowledge to support recruitment and protocol compliance.
- Mentor and train less experienced CRAs and provide input into their development.
- Participate in global or local task forces and initiatives, as applicable, and perform activities assigned by the manager.
- Conduct ongoing risk assessment and collaborate with the Central Monitoring team to identify study-performance or patient-safety issues early.
- Resolve site risk signals using critical thinking and knowledge of site processes; implement preventive and corrective action plans as needed to mitigate risk and promote compliance.
- Identify, evaluate, and recommend potential investigators and sites for planned clinical studies.
- Ensure the quality and timely submission of site data, including appropriate reporting and follow-up of safety events by site personnel.
- Maintain audit and regulatory inspection readiness at assigned sites.
- Manage investigator payments in accordance with executed contract obligations, as applicable.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- 401(k).
- Eligible employees may participate in short-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
