Clinical Research Associate II

Advance AbbVie's clinical development pipeline by supporting high-quality clinical research and translating scientific objectives into effective clinical-trial execution.

Serve as a primary sponsor point of contact for assigned investigative sites, strengthening site relationships and supporting successful trial delivery.

Work with study teams, AbbVie R&D stakeholders, investigators, and site staff to improve data integrity, compliance, study performance, patient safety, and customer experience.

Serve as the primary AbbVie sponsor contact for the investigative site and provide contextual information regarding clinical trials while connecting stakeholders with site personnel.

Align, train, motivate, support, guide, and mentor site staff and Principal Investigators on clinical-trial goals, protocols, and patient-treatment principles.

Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring in accordance with protocols and monitoring plans.

Ensure trial activities comply with applicable regulations, Good Clinical Practice (GCP), ICH Guidelines, AbbVie SOPs, and quality standards.

Protect study-subject safety and ensure appropriate trial conduct throughout the site lifecycle.

Develop and customize site-engagement strategies for assigned studies and adapt strategies based on site needs and performance.

Gather local and site-level insights and use site-engagement tools to track progress and measure impact.

Apply scientific understanding of protocols, therapeutic areas, assets, clinical landscapes, and patient journeys to clinical-trial execution.

Develop and implement effective patient recruitment and retention techniques and plans based on the disease journey.

Perform continuous proactive risk assessment in collaboration with Central Monitoring teams.

Monitor site activities to identify early study-performance and patient-safety issues.

Critically evaluate site risk signals and site processes and implement preventive and corrective action plans when necessary.

Ensure data submitted by sites is accurate and timely, including appropriate reporting and follow-up of safety events.

Maintain audit and regulatory inspection readiness at assigned sites.

Manage investigator payments according to executed contractual obligations where applicable.

Independently identify, evaluate, and recommend potential investigators and clinical sites on an ongoing basis.

Use professional networking and internal AbbVie requests to identify qualified investigators and support placement of planned clinical studies.

Mentor and train less-experienced CRAs across clinical-trial activities.

Support onboarding and development of junior CRAs.

Listen to and incorporate different viewpoints to improve outcomes.

Participate in or lead global and local task forces and initiatives as assigned by management.

Tertiary qualification in a health-related discipline such as Medicine, Science, Pharmacy, or Nursing preferred.

Minimum 3 years of clinically related experience, including preferably 2 years of independent clinical-research monitoring of investigational drug or device trials.

Experience with risk-based monitoring and on-site/off-site monitoring preferred.

Knowledge of therapeutic-area indications and ability to apply scientific concepts to clinical-trial conduct.

Strong knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.

Advanced communication, planning, organizational, interpersonal, presentation, active-listening, and cross-functional collaboration skills.

Ability to leverage technology, tools, and resources to provide customer-centric site support.

Ability to independently apply functional expertise, critical thinking, and sound judgment to resolve clinical-site issues.

High integrity and adherence to AbbVie's code of business conduct and leadership values.