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Clinical Trials Management Associate

  • Full Time, onsite
  • Infotree Global Solutions
  • Santa Monica, United States of America
Salary undisclosed

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Overview:

  • Provides support in clinical study site coordination, monitoring, and data management, either directly or through CROs.
  • Contributes to study implementation, site selection, and ensures compliance with regulatory guidelines, protocols, and SOPs.
  • Requires travel and strong interpersonal, written, and presentation skills.

Key Responsibilities:

  • Assist with site selection, study initiation, and ongoing site coordination.
  • Monitor study sites, verifying data and regulatory documents for compliance with protocol and Monitoring Plan.
  • Support protocol reviews, case report forms, informed consent forms, and clinical reports under supervision.
  • Compile investigator brochures and assist in resolving routine monitoring issues.
  • Prepare safety, interim, and final study reports, resolving any data discrepancies.
  • Participate in departmental or cross-departmental strategic initiatives and SOP development.

Education and Skills Requirements:

  • Proficiency in Microsoft Word, PowerPoint, and Excel.
  • Familiarity with medical/scientific terminology.
  • Knowledge of FDA/EMEA regulations, ICH guidelines, and GCPs governing clinical trials (preferred).
  • Excellent verbal, written, and presentation skills.
  • Must meet all qualifications for the Clinical Project Assistant role.