Senior Clinical Research Associate

5 days ago


Raleigh, North Carolina, United States Catalyst Clinical Research LLC Full time
Job Overview

Catalyst Clinical Research LLC is seeking a highly skilled Senior Clinical Research Associate to join our team. As a key member of our clinical research team, you will play a critical role in monitoring clinical trial programs and managing regional clinical trial sites.

Key Responsibilities:

  • Monitor clinical trials according to monitoring plans to achieve project goals, conduct site evaluations, study initiations, routine monitoring, site close-outs, and FDA audit preparations.
  • Effectively communicate with site study staff and Catalyst clinical research personnel to report study site status, disseminate information, and resolve study-related issues.
  • Partner with assigned clinical project teams to ensure successful trial execution.
  • Assist with Investigator Meetings planning/presentations, data collection, and FDA submission preparations.
  • Manage work activities in a time and cost-effective manner to ensure budgetary guidelines and project timelines are met.
  • Participate in internal and/or external meetings to maintain current knowledge on applicable regulations and guidelines.

Requirements:

  • Bachelor's degree in a science or health-related discipline or equivalent of 7 years industry experience.
  • Minimum of 5 years' experience in clinical research with direct site monitoring experience with a sponsor company or CRO and 3 years of recent oncology clinical trial experience.
  • Strong knowledge of clinical trial monitoring, regulatory compliance, clinical research methodology, and all applicable regulations and guidelines.
  • Strong organizational and time management skills and the ability to work independently.
  • Excellent communication and interpersonal skills.
  • Flexibility and ability to travel routinely to meet project requirements.
  • Strong knowledge of standard computer applications.

Catalyst Clinical Research LLC is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.



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