Company Description 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. We 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 our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research. Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes.
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. Ensures safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines,
and applicable regulations. Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
Manages investigator payments as per executed contract obligations. Negotiates investigator/ hospital agreements with stakeholders. Maintain and complete own expense reports as per local and applicable guidelines.
Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators. Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred with Clinical Trails Master ́s Degree. Minimum of 1 year of clinically-related experience, of which a period of 6 months is preferable in independent clinical research monitoring or experience as a Study CoordinatorExperience in on-site monitoring of investigational drug or device trials is required.
Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials. Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations. Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
Remote based in madrid
📌 Contract Clinical Research Associate (Madrid)
🏢 AbbVie
📍 Madrid