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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.Abbvie.Com . Follow @abbvie on Twitter, Facebook, Instagram, YouTube, and LinkedIn.
Job Description
Responsibilities 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 1-3 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes.
Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives.
Proactively manages the site and ensures action plans are put into place as needed to ensure compliance.
Ensures regulatory inspection readiness at assigned clinical sites.
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.
Maintains and completes own expense reports as per local and applicable guidelines.
Identifies, evaluates, and recommends new/potential investigators/sites on an ongoing basis.
Qualifications Appropriate tertiary qualification, health-related (e.g., Medical, Scientific, Nursing) preferred.
Minimum of 2 years of clinically-related experience in Oncology.
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.
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