Clinical Operations Director

8 hours ago


Hialeah, Florida, United States EVOLUTION RESEARCH GROUP Full time
Job Summary: The Executive Director of Clinical Operations at EVOLUTION RESEARCH GROUP is responsible for managing clinical trials, ensuring protocol compliance, and overseeing staff and study operations. This role requires adherence to Good Clinical Practices (GCP), International Committee on Harmonization (ICH) guidelines, and company SOPs. Key responsibilities include staff management, protocol analysis, quality management, and study oversight. Key Responsibilities:
  • Supervise and mentor clinical operations staff.
  • Oversee study protocols, ensuring compliance and quality control.
  • Collaborate with Principal Investigators and Site Directors on study assignments and enrollment strategies.
  • Manage HR duties, including performance evaluations, recruitment, and training.
  • Ensure adherence to protocols and report deviations to sponsors and regulatory bodies.
  • Work with Site Director and Principal Investigator to assign primary clinical research coordinator.
  • Review with Principal Investigator and Site Director, any components of the study for which additional information or clarification are required prior to the initiation of the study.
  • Perform study close-out procedures.
Qualifications:
  • College degree preferred.
  • 7-10 years in clinical operations, with 5+ in senior leadership role.
  • Strong knowledge of GCP, ICH, and regulatory guidelines.
  • Excellent communication and organizational skills.
  • Ability to travel and proficiency in Word, Excel, and clinical software.


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