Overview
Skills
Job Details
About Nexinfo:
NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors.
They offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions.
The company aims to help businesses across industries achieve their goals through industry best practices, lean process design,
and advanced software solutions. Their 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.
Job Title: Clinical Trials Management Associate
Location: Santa Monica, El Segundo, La Verne, Oceanside, or Foster City CA
Type: Contract
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 Google Cloud Platforms governing the conduct of clinical trials is desirable.
Thanks and Regards,
Joseph