Clinical Trials Management Associate - I

Job Title: Clinical Trial Coordinator

Location: Santa Monica CA 90404

Duration: 12 months (contract)

Shift Hours: Monday Friday

Description:

• 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.
• 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.