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CRA/Senior CRA (Oncology)

New Jersey All, NJ

Posted: 11/01/2018 Job Type: Clinical Job Number: JN -112018-22957
  • The CRA/Senior CRA performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Oncology and Pharma clinical trials within the country
  • The CRA/Senior CRA is responsible to deliver data within timelines and required quality standard, responsible for adherence to monitoring procedures in accordance with GCP and ICH, local regulations and SOPs
  • Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit), if require
  • Conducts co-monitoring visits, if required
  • Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
  • Attends onboarding-, disease indication and project specific training and general CRA training as required
  • Documents monitoring activities appropriately following ICH-GCP and standards
  • Conducts Quality Oversight Visits (QOV), as requested
  • Completes monitoring visit/ QOV reports timely
  • Assists with investigator/site identification
  • Assists site to prepare Ethics Committee submissions
  • Facilitates clinical trial site contract and budget negotiation
  • Manages site queries and communications
  • Assists in managing clinical trials, if required
  • Establishes regular lines of communication with sites and COMs
  • Provides protocol and related study training to assigned sites
  • Evaluates the quality and integrity of site practices escalating quality issues as appropriate
  • Manages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
  • Collaborates with CRA Group / CRM to ensure recruitment plans and execute contingency plans, as needed
  • Performs additional task as assigned
  • Degree Required
  • At least 3 to 4 years of experience
  • Oncology monitoring experience
    Willing to travel 75%
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