Multiple Openings for CRA II – REMOTE POSITIONS covering either Denver, CO or New York Area – MUST be local to one of the regions
The Senior CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials within the country.
The Senior CRA is responsible to deliver data within timelines and required quality standard, and for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs.
Trial Monitoring strategy
Conducts feasibility and screen potential Investigators and networks to evaluate capabilities for conducting clinical trials
Allocation, initiation and conduct of trials
Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommends sites to participate in clinical trial
Is the frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectation on milestone and deliveries
Manages assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and Novartis procedures
Facilitates the preparation and collection of site and country level documents
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. Retrains site personnel as appropriate
Conducts continuous monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data integrity and patient safety
Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements
Minimum of 3 years experience in site monitoring
Excellent knowledge of the drug development process specifically clinical trial/research
Knowledge of international standards (GCP/ICH, FDA, EMEA)
Basic project management skills to support in CSM activities.
Ability to travel domestically (and possibly internationally) as needed to study sites and for training and meetings.
A minimum of 50% overnight travel may be required.
Advanced communication skills, ability to influence others.
Advanced data accuracy: Ability to work focused with a great attention to detail.
Ability to manage sites independently
Source: Job Diva – Job Listing