Clinical Research Associate, Sponsor Dedicated

Lifelancer
New York, NY
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. The role requires at least 2 years of on-site monitoring experience and a Bachelor's Degree in a scientific discipline or health care.

Requirements

  • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
  • 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.
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