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