Clinical Research Associate - Sponsor Dedicated

Lifelancer
Overland Park, KS
Category Research
Job Description
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Requirements

  • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements
  • Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans
  • Collaborate and liaise with study team members for project execution support as appropriate

Benefits

  • 401k Matching
  • Tuition Reimbursement
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