Clinical Research Associate II - Dermatology- Southern CA

About the role

Advance 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. Partners with the investigator and site staff for meaningful and effective engagements positioning AbbVie as the choice in clinical trials. Focus on site clinical research that ensures appropriate conduct of the trial while driving improvement in data integrity, compliance, overall study performance and customer experience.

Responsibilities

• Primary point of contact for the investigative site.
• Provide high-level competency or experience in offering 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 clinical trial program goals, protocol, and patient treatment principles to ensure a trusted partnership.
• Conduct site evaluation, site training, routine monitoring, and site closure activities in compliance with protocol, monitoring plans, applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie SOPs, and quality standards, ensuring safety and protection of study subjects.
• Demonstrate advanced understanding of site engagement and ability to customize site engagement strategy for assigned study(ies). Gather local/site insights and use site engagement tools such as CRM to report/track progress and measure impact.
• Apply advanced competency to connect study protocol, scientific principles, and clinical trial requirements to day-to-day clinical trial execution activities.
• Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. Develop solid knowledge of therapeutic area, asset, and clinical landscape/patient journey to enable successful patient recruitment and overall protocol compliance.
• Provide experienced-level mentorship to less experienced CRAs on various aspects of work and contribute input into their development. May participate in global/local task forces and initiatives. Responsible for activities as assigned by manager.
• Conduct continuous risk-assessment, in collaboration with the Central Monitoring team, to monitor site activities and detect early overall study performance or patient safety issues.
• Apply critical thinking to resolve site risk signals with a robust understanding of site processes to drive study execution. Ensure preventative and corrective action plans are implemented to mitigate risk and promote compliance using a customer-centric approach.
• Identify, evaluate, and recommend new/potential investigators/sites on an ongoing basis, including through networking or internal AbbVie requests to assist in placement of planned clinical studies with qualified investigators.
• 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. Ensure audit and regulatory inspection readiness at assigned clinical site at all times.
• Manage investigator payments as per executed contract obligations, as applicable.

Qualifications

• Appropriate tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred.
• Minimum of 1 year of clinically related experience, of which a period of 6 months is required in clinical research monitoring of investigational drug or device trials.
• Familiar with risk-based monitoring approach, onsite and offsite monitoring.
• Knowledge of appropriate therapeutic area indications preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.
• Advanced knowledge of existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.
• Demonstrate strong cross-functional collaboration skills among internal and external stakeholders.
• Demonstrate strong planning and organizational skills and 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 the health of the site.
• Strong interpersonal skills with excellent written, verbal, active listening, and presentation skills, with 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.
• Act 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.