Clinical Trials Management Associate

Job title

Clinical Trials Management Associate

Santa Monica, El Segundo, La Verne, Oceanside, or Foster City CA

Contract

Nex Info is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. The company offers services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. The ERP-related services address challenges such as inventory management, product lifecycle management, demand management, forecasting, sales and operations planning, business intelligence, security compliance, and financial alignment.

The job requires meeting all requirements for the Clinical Project Assistant position and 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 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, 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 and assist 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 Google Cloud Platform governing the conduct of clinical trials is desirable.

• Must meet all requirements for Clinical Project Assistant position and demonstrate proficiency in relevant areas.

• Familiarity with routine medical/scientific terminology
• Proficiency with Word, PowerPoint, and Excel
• Knowledge of FDA/EMEA regulations, ICH guidelines;
  Google Cloud Platforms is desirable

Travel is required.

• Excellent verbal, written, interpersonal and presentation skills
• Ability to work under supervision and contribute to study documentation

• Entry level

• Contract

• Research, Analyst, and Information Technology

• Software Development