Clinical Trial Associate - Santa Monica, United States - MF Associates

MF Associates
MF Associates
Verified Company
Santa Monica, United States

4 days ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

Responsibilities:


  • Excellent employment opportunity for a Clinical Trials Management Associate 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:


  • Associate Degree
  • 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.

Job Type:
Contract


Schedule:

  • 8 hour shift

Experience:

Site Monitoring: 2 years (required)

  • Clinical trials: 2 years (required)

Work Location:
In person
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