Allergan Aesthetics, an AbbVie company, is looking for a Clinical Research Associate II to ensure successful protocol-level execution across clinical studies. Your role is critical in anticipating and proactively solving study-related site issues to support AbbVie's emergence as a world-class R&D organization, focusing on the start-up, execution, and close-out of studies.
What You'll Do
- Monitor activities at clinical investigative sites to ensure successful protocol execution.
- Ensure adherence to federal and local regulations, GCP, ICH Guidelines, and AbbVie SOPs and Monitoring Plans.
- Conduct site qualification, initiation, interim monitoring, and closeout visits for Phase 1-4 studies.
- Oversee site personnel activities, motivate and influence them to meet study objectives, and proactively manage sites to ensure compliance.
- Ensure regulatory inspection readiness at assigned clinical sites.
- Ensure the quality and timely submission of study data, including appropriate reporting and follow-up for all safety events.
- Ensure the safety and protection of study subjects through compliance with the monitoring plan and all applicable guidelines.
What We're Looking For
- Experience in on-site monitoring of investigational drug or device trials.
- Current in-depth knowledge of appropriate therapeutic indications as they relate to clinical trials.
- Current in-depth knowledge of regulations governing clinical research and ICH/GCP Guidelines.
Nice to Have
- An appropriate tertiary, health-related qualification (e.g., Medical, Scientific, Nursing).
- A minimum of 1 year of clinically-related experience, with 6 months preferably in clinical research monitoring.
Allergan Aesthetics, an AbbVie company, is an equal opportunity employer.
