Who are we?
Bright Research is a dynamic and growing medical device Clinical Research Organization (CRO) located in downtown Minneapolis. We manage clinical trials from concept to completion, with smarts and sophistication to make the complex look easy. We are seeking a Study Director. This is a position at our downtown Minneapolis office.
Who makes an excellent fit for Bright?
Are you curious and passionate about MedTech and translating data into clinical stories to advance science? If you have strong communication skills, creativity, resilience and a positive attitude, we would love to hear from you!
What does the role require?
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Serve as the primary sponsor contact, communicate key study updates, and ensure alignment among sponsors, Bright leadership, and study team members.
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Direct team members on timelines, strategies, and study activities; develop and manage protocols, plans, and study documents; ensure accurate, timely study reporting.
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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.
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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.
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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.
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Provide training and guidance to entry-level team members and participate in staff and project team meetings as needed.
Qualifications
Education
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Bachelor’s or master’s degree in a scientific field, or equivalent work experience
Experience
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At least 5+ years of medical device industry, clinical research experience in a study management or execution role; Management experience preferred
Benefits
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Salary range: $90,000 - $125,000
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Complimentary paid parking, comprehensive health insurance (medical, dental, and vision), paid parental leave, short- and long-term disability benefits, a 401(k) with company match, tuition reimbursement, at least 12 paid company holidays, and access to an on-site gym.