Senior Clinical Research Associate - Remote

Job Description

Advance Abb Vie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients and leveraging advanced capabilities to drive industry‑leading performance.

Partner with study teams, Abb Vie internal R&D stakeholders, investigators, and site staff for meaningful and effective engagements positioning Abb Vie as the partner of 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.

• Act as the Primary Sponsor point of contact for the investigative site, providing contextual information on clinical trials, connecting stakeholders to investigative sites and strengthening Abb Vie's positioning.

• Align, train and motivate site staff and principal investigators on the goals of the clinical trial program, protocol, and patient treatment principles for the trial, ensuring a trusted partnership. Support, guide and mentor junior personnel on site management activities.

• Conduct site evaluation, site training, routine on‑site and off‑site monitoring, and site closure monitoring activities in accordance with applicable regulations, GCPs, ICH guidelines, Abb Vie SOPs and quality standards, ensuring safety and protection of study subjects.

• Maintain a superior understanding of site engagement and customize engagement strategy for assigned study/ies, applying new strategies as needed. Gather local/site insights, utilize engagement tools to report and track progress and measure impact.

• Connect the study protocol, scientific principles and trial requirements to day‑to‑day execution activities. Generate and ensure effective recruitment and retention plans based on the patient disease journey. Develop solid knowledge of the therapeutic area, asset and clinical landscape to enable successful recruitment and protocol compliance.

• Mentor and train less experienced CRAs on various aspects of work and provide input into their development. Support local onboarding of more junior CRAs and demonstrate an open‑to‑learning approach.

• Participate or lead in global/local task forces and initiatives, performing activities assigned by the manager.

• Conduct continuous risk assessment proactively, collaborating with the Central Monitoring team to monitor activities conducted by clinical sites, detect early performance or safety issues, and implement corrective actions to mitigate risk and promote compliance.

• Independently identify, evaluate and recommend new or potential investigators/sites on an ongoing basis, demonstrating expert insight and sound decision‑making. Identify potential sites through networking or Abb Vie requests to support planned studies.

• Ensure quality of data submitted from study sites, timely submission of data, appropriate reporting of safety events, audit and regulatory inspection readiness at all times. Manage investigator payments as per contract obligations.

• Appropriate tertiary qualification in a health‑related discipline (e.g., Medicine, Science, Pharmacy, Nursing) preferred.
• Minimum of 3 years of clinically related experience, including at least 2 years in independent clinical research monitoring of investigational drug or device trials across any therapeutic area. Familiarity with risk‑based monitoring and on‑site/off‑site monitoring.
• Knowledge of therapeutic area indications with the ability to understand and apply scientific concepts related to clinical trial conduct.
• Superior knowledge of local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
• Advanced communication and cross‑functional collaboration skills with internal and external stakeholders.
• Excellent planning and organizational skills, capable of working efficiently in a dynamic environment with competing projects.
• Proficiency in leveraging technology, tools and resources to deliver customer‑centric support based on site health.
• Strong interpersonal skills with excellent written, verbal, active listening and presentation abilities.
• Ability to use functional expertise, critical thinking and…