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Remote CRA

New York City Metro Area, NY

Posted: 09/11/2019 Job Type: Clinical Job Number: JN -092019-25586
  • Performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of clinical trials
  • 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 with sites to ensure successful collaboration, meeting expectation on milestone and deliveries
  • Manages assigned study sites and networks according to the monitoring plan and 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
  • Attends onboarding, disease indication and project specific training and general CRA training as required
  • Documents monitoring activities appropriately following 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

Requirements:

  • Handling the NYC location- candidate must be local to this location and willing to travel via air as needed to sites within the northeast region based on business needs
  • Ophthalmology, Cardiovascular and/or Respiratory experience
  • Minimum of 3 years of experience independent monitoring experience from a pharmaceutical or CRO company is required
  • A minimum of 50% overnight travel may be required


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