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 our 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 investigative 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 and 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 an advanced understanding of site engagement and customize site engagement strategies for assigned studies. Utilize site engagement 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. Evaluate and ensure effective recruitment and retention techniques/plans 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 overall protocol compliance.
• Mentor and train less experienced Clinical Research Associates (CRAs) on various aspects of work 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 with critical thinking and a robust understanding of site processes to drive study execution. Ensure preventative and corrective action plans are implemented as needed to mitigate risk and promote compliance.
• Identify, evaluate, and recommend new/potential investigators/sites on an ongoing basis through networking or internal AbbVie requests.
• Ensure quality of data submitted from study sites and timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Maintain audit and regulatory inspection readiness at assigned clinical sites.
• Manage investigator payments as per executed contract obligations, as applicable.

Requirements

• Bachelor’s degree or equivalent; health-related 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 appropriate therapeutic area indications is preferred, with the ability to understand and apply scientific concepts related to the conduct of clinical trials.
• Advanced knowledge of existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.
• Strong cross-functional collaboration skills among internal and external stakeholders.
• Strong planning and organizational skills, with the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
• Advanced ability to leverage technology, tools, and resources to provide customer-centric support based on site health.
• Strong interpersonal skills with excellent written, verbal, active listening, and presentation skills. Ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
• Ability to use functional expertise with appropriate guidance, leverage critical thinking skills, and apply 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.

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
• Eligibility to participate in short-term incentive programs.

Pay

The compensation range for this role is based on the job grade and may vary depending on geographic location. Individual compensation paid within this range will depend on many factors. This range may be modified in the future.