Clinical Research Associate II

AbbVie

1d • Hybrid

About The Position

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. They 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 their Allergan Aesthetics portfolio. The Clinical Research Associate II serves as the primary Sponsor point of contact for investigative sites, providing contextual information on clinical trials, connecting stakeholders to sites, and strengthening AbbVie’s positioning. This role involves aligning, training, and motivating site staff and principal investigators on trial goals, protocol, and patient treatment principles to ensure a trusted partnership. Responsibilities include conducting site evaluation, training, routine on-site and off-site monitoring, and site closure activities in compliance with regulations, GCPs, ICH Guidelines, and AbbVie SOPs, ensuring subject safety. The associate will customize site engagement strategies, gather local insights, and track progress. They need a fundamental understanding of connecting study protocols, scientific principles, and clinical trial requirements to daily execution, evaluating recruitment and retention techniques, and developing therapeutic area knowledge. The role also involves continuous proactive risk-assessment, collaborating with the Central Monitoring team to detect study performance or patient safety issues, and ensuring preventative and corrective action plans are in place. They identify, evaluate, and recommend new investigators/sites, ensure data quality and timely submission, including safety event reporting, and maintain audit and regulatory inspection readiness. Managing investigator payments is also part of the role.

Requirements

• Appropriate tertiary qualification in health-related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) or experience or equivalent work experience.
• Knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
• Able to work collaboratively and cross functionally to develop and sustain working relationships.
• Demonstrate planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
• Ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
• Interpersonal skills with strong 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 judgement to address clinical site issues.
• Acts with integrity in accordance with AbbVie code of business conduct and leadership values.
• Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment.

Nice To Haves

• Appropriate tertiary qualification in health-related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred.
• Clinically related experience, in clinical research coordinating or data management preferred.
• Knowledge of appropriate therapeutic area indications is preferred with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials.

Responsibilities

• Considered as the primary Sponsor point of contact for the investigative site, provides contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning.
• Aligns, trains and motivates the site staff and principal investigator with support as needed on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership.
• Conducts site evaluation, site training, routine on-site and off-site monitoring, and site closure activities with support as needed, in compliance to the protocol and monitoring plans and accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and to quality standards in conducting clinical research, ensuring safety and protection of study subjects.
• Customize site engagement strategy for assigned study (ies) with support as needed.
• Gather local/site insights and utilize site engagement tracking tools, to report/track progress and measure impact of that strategy.
• 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.
• Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
• Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
• Identifies, evaluates and recommends new/potential investigators/sites with support as needed from more experienced Site Monitors.
• Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
• Manages investigator payments as per executed contract obligations, as applicable.

Benefits

• Reasonable accommodation

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level