Clinical Research Associate II (19-00616) – NJ – East Hanover

Remote CRA II / Clinical Research Associate II with 50% travel within WA, OR, MT, UT, NV, CA

Summary:
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.
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
Manages assigned study sites and networks, if applicable, conducting phase I-IV protocols according to the monitoring plan and Company 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
Is accountable for continuously updating all electronic systems (global and local) relevant to perform job functions
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
Attends onboarding-, disease indication and project specific training and generalCRAtraining as required 
Documents monitoring activities appropriately following Company standards
Collaborates with the CRA Group Head/CSM to ensure recruitment plans and execute contingency plans, as needed
Participates from audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines
Performs additional task as assigned

Skills:
Minimum of 3 years of experience in site monitoring
Excellent knowledge of the drug development process specifically clinical trial/research
Knowledge of international standards (GCP/ICH, FDA, EMEA)
Ability to manage multiple priorities and manage time efficiently.
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.
Good strategic thinking: Ability to anticipate potential issues and take appropriate actions with or without supervision.

Education:
Degree in scientific or healthcare discipline
 
Source: Job Diva – Job Listing

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