Clinical Research Associate II - Southern CA

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas including immunology, oncology, and neuroscience—and products and services in our Allergan Aesthetics portfolio.

About the role

This position is field-based/remote in Southern California. Candidates must reside in Southern California and be willing to travel for site visits. The role advances AbbVie’s pipeline by striving for excellence in clinical research, turning science into medicine for patients, and leveraging new advanced capabilities to drive industry-leading performance.

Responsibilities

• Serve as the primary point of contact for the investigative site, providing contextual information on clinical trials, connecting stakeholders to sites, and strengthening AbbVie’s positioning.
• Align, train, and motivate site staff and principal investigators on the goals of the clinical trial program, protocol, and patient treatment principles to ensure a trusted partnership.
• Conduct site evaluation, training, routine, and site closure monitoring activities in compliance with the protocol, monitoring plans, applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards to ensure safety and protection of study subjects.
• Develop and customize site engagement strategies for assigned studies, utilizing tools such as Customer Relationship Management (CRM) to report/track progress and measure impact.
• Connect study protocol, scientific principles, and clinical trial requirements to day-to-day execution activities, ensuring effective recruitment and retention techniques based on the patient disease journey.
• Develop solid knowledge of the therapeutic area, asset, and clinical landscape/patient journey to enable successful patient recruitment and protocol compliance.
• Mentor and train less experienced Clinical Research Associates (CRAs) on various aspects of the role and provide input into their development; may participate in global/local task forces and initiatives.
• Proactively conduct continuous risk-assessment in collaboration with the Central Monitoring team to detect early study performance or patient safety issues.
• Resolve site risk signals using critical thinking and a robust understanding of site processes to drive study execution; implement preventative and corrective action plans as needed.
• Identify, evaluate, and recommend new or potential investigators/sites on an ongoing basis through networking or internal requests.
• Ensure quality and timely submission of data from study sites, including appropriate reporting and follow-up for all safety events by site personnel.
• Maintain audit and regulatory inspection readiness at assigned clinical sites at all times.
• Manage investigator payments per executed contract obligations, as applicable.

Qualifications

• Bachelor’s degree or equivalent; health-related degree preferred (e.g., Medical, Scientific, Nursing, Pharmacy).
• Minimum of 1 year of clinically related experience, including at least 6 months in clinical research monitoring of investigational drug or device trials.
• Familiarity with risk-based monitoring approaches, including onsite and offsite monitoring.
• Knowledge of therapeutic area indications preferred, with the ability to understand and apply scientific concepts related to clinical trial conduct.
• Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.
• Strong cross-functional collaboration skills among internal and external stakeholders.
• Excellent planning, organizational, and time-management skills to work effectively in a dynamic environment with competing deadlines.
• Advanced ability to leverage technology, tools, and resources to provide customer-centric support based on site health.
• Strong interpersonal skills, including excellent written, verbal, active listening, and presentation abilities, with a focus on building trusted site relationships.
• Ability to apply functional expertise with guidance, leverage critical thinking, and exercise good judgment to address clinical site issues.
• Acts with integrity in accordance with AbbVie’s code of business conduct and leadership values.
• Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.

Pay

The compensation range for this role is based on the job grade at the time of posting. Individual compensation within this range will depend on geographic location and other factors. This role may also be eligible for participation in short-term incentive programs.

Benefits

• Comprehensive package including paid time off (vacation, holidays, sick leave).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.