Clinical Trials Management Associate - I

RICEFW Technologies - Santa Monica, CA

Full-time

Santa Monica, CA

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About the position

The Clinical Project Assistant plays a crucial role in supporting the administrative aspects of clinical trials, including site selection, study implementation, and ongoing coordination of study sites. This position involves monitoring study sites, performing data collection, and ensuring compliance with regulatory requirements and protocols. The role requires strong communication skills and familiarity with medical terminology, as well as proficiency in relevant software applications.

Responsibilities

• Provide administrative assistance in site selection and study implementation.
• Coordinate ongoing activities at study sites, either directly or through CROs.
• Monitor study sites, performing routine data collection and source data verification.
• Review routine regulatory documents and files to ensure compliance with protocols and regulations.
• Assist in the review of protocols, informed consents, and case report forms under supervision.
• Help compile investigator brochures and resolve routine monitoring issues as needed.
• Assist in the preparation of safety, interim, and final study reports, including resolving data discrepancies.

Requirements

• Demonstrated proficiency in relevant areas for the Clinical Project Assistant position.
• Excellent verbal, written, interpersonal, and presentation skills.
• Familiarity with routine medical/scientific terminology.
• Proficiency in Microsoft Word, PowerPoint, and Excel.
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing clinical trials.

Nice-to-haves

• Experience in contributing to SOP development.
• Ability to participate in departmental or interdepartmental strategic initiatives under general supervision.