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Bright Research · 2 months ago

Senior Clinical Research Associate

Minneapolis, MN

Full-time

Onsite

Mid, Senior Level

$70K/yr - $100K/yr

3+ years exp

Bright Research is a dynamic and growing medical device Clinical Research Organization located in downtown Minneapolis. They are seeking a clinical research associate to manage clinical trials from concept to completion, ensuring quality and regulatory compliance throughout the study lifecycle.

ConsultingMedical DeviceService Industry

Responsibilities

Collect, review, and maintain essential clinical trial documents throughout the study lifecycle using the electronic Trial Master File (eTMF), ensuring quality and regulatory compliance

Schedule, prepare for, and conduct site visits (SIVs, IMVs, COVs), including writing visit reports, resolving queries, and ensuring adherence to the monitoring plan and protocols

Monitor site activities for compliance with protocols and regulations; identify and escalate site performance or quality issues and support their resolution

Collaborate with site staff and study teams, lead site personnel training, and provide feedback on protocol conduct, documentation, and recruitment

Contribute to the development of monitoring tools and training materials, perform quality control checks on study documents, and assist with other clinical operations projects as needed

Qualification

Clinical trial monitoringSite managementData managementClinical trials methodologyCommunication skills

Required

Bachelor's or master's degree in a scientific field or engineering field, or equivalent work experience

At least 3 years of experience in clinical study monitoring, site management, and data management, and/or research experience with proficient understanding of clinical trials methodology and terminology