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Bright Research · 1 month ago

Study Director

Minneapolis, MN

Full-time

Onsite

Mid, Senior Level

$90K/yr - $125K/yr

3+ years exp

Bright Research is a dynamic and growing medical device Clinical Research Organization (CRO) located in downtown Minneapolis. They are seeking a Study Director to serve as the primary sponsor contact, manage study protocols and timelines, and ensure compliance with regulatory requirements. The role involves collaboration with sponsors and teams to advance clinical research projects.

ConsultingMedical DeviceService Industry

Responsibilities

Serve as the primary sponsor contact, communicate key study updates, and ensure alignment among sponsors, Bright leadership, and study team members

Direct team members on timelines, strategies, and study activities; develop and manage protocols, plans, and study documents; ensure accurate, timely study reporting

Work with sponsors and site personnel to identify, qualify, select, initiate, and train study sites; collaborate with Clinical Research Associate (CRAs) to resolve monitoring findings

Ensure adherence to protocols, Good Clinical Practice (GCPs), regulatory requirements, IRB/EC standards, and internal procedures; identify and mitigate study risks; support audits and inspections

Coordinate with departments such as Data Management and Regulatory; manage activities with third-party vendors (e.g., translation services, core labs); facilitate or assist with investigator, committee, and study team meetings

Provide training and guidance to entry-level team members and participate in staff and project team meetings as needed