Summary -Monitors patient data & study-related information related to clinical study sites and clinical trial participation..
Ensures the investigator adheres to research protocols, regulatory requirements and good clinical practices and provides input into data validation plan.
Provides timely and accurate monitoring of patient data and study-related information from source documents, research records, and site visits where applicable.
May monitor study sites and audit facility selection.
Key Responsibililties • Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliverables with true ownership mindset • Manages assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures • Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects.
Performs continuous training for amendments and new site personnel as required.
Re-trains site personnel as appropriate • Conducts continuous site monitoring activities (onsite and remote).
Implements site management activities to ensure compliance with protocol, ICH/GCP, global and local regulation including Health Authorities, IRB/EC, data privacy requirements, global and local processes as applicable.
Documentation according to GDP and Novartis standards. • Identifies deficiencies in site processes and monitor site processes performed outside the site, works in close collaboration with site on risks mitigation and process improvements • Promotes a compliance culture advocating adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times • Establish a strong partnership and true collaboration with the site, to increase patient density and decrease issues at site. • Early engagement with site on patient inventory and patient flow in advance of SIV in close collaboration with global and local study team • Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements • Attends onboarding-, disease indication and project specific training and general CRA training as required • Proactively collaborates with the SSO Clinical Project Manager (CPM) and CRA Manager as well as MSL, CRMA and medical advisor to ensure optimal recruitment, site development and data quality
Requirements
Requirement • Up to 2 years pharmaceutical industry experience or other relevant experience.
Central/in-house monitoring or field monitoring experience is desirable • Excellent time management and organization capabilities, including ability to prioritize and multi-task • Risk based mindset (from issue management to risk identification) supported by Novartis systems • Early adopter and open mindset across borders to support one study approach • Good knowledge of drug development process specifically clinical trial/research • Clinical and therapeutic knowledge.
Knowledge of international standards (GCP/ICH, FDA, EMA) • Understanding the purpose of the CRA (Patient Safety; Data Integrity; PI oversight; GCP/ICH & Protocol Compliance) • Degree in scientific or healthcare discipline (or, for United States: 4-year degree plus relevant, related healthcare experience).Fluent in both written and spoken
English and country language
Desired Clinical Research, Clinical Study Reports, Clinical Trial Management Systems (CTMS), Clinical Trials, Clinical Trials Monitoring, Collaboration, Data Integrity, Decision Making, Life Science
