Demo

Clinical Trial Management Associate

Fladger Associates
Santa Monica, CA Temporary
POSTED ON 2/21/2025
AVAILABLE BEFORE 5/19/2025

Responsibilities :

  • Excellent employment opportunity for a Clinical Trials Management Associate - I in the Santa Monica, CA area.
  • Must meet all requirements for Clinical Project Assistant position and have demonstrated proficiency in all relevant areas.
  • Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
  • Monitors fairly routine study sites, performing routine data collection, source data verification, and review of routine regulatory documents / files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
  • Under supervision may assist in review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.
  • May assist in compilation of investigator brochures under close supervision.
  • May resolve routine monitoring issues.
  • Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
  • Travel is required.

Experience :

  • Excellent verbal, written, interpersonal and presentation skills are required.
  • Must be familiar with routine medical / scientific terminology.
  • Must be familiar with Word, PowerPoint, and Excel.
  • Knowledge of FDA and / or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is desirable.
  • Must be able to participate in departmental or interdepartmental strategic initiative under general supervision.
  • Must be able to contribute to SOP development.
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