Job Description

Summary
We are seeking a Senior Clinical Research Associate responsible for initiating and overseeing clinical centers to ensure the successful conduct of active clinical studies. This role involves qualifying, training, monitoring, and overseeing clinical centers to ensure adherence to study protocols and regulatory standards. This position is based in Golden Valley, MN, with required on-site presence and travel up to 30%.

Responsibilities

• Identify and assess clinical study centers for participation in trials.
• Train clinical centers on study protocols, data collection, and good clinical practices (GCP).
• Manage clinical sites, including enrollment monitoring, data quality assurance, and addressing study-related queries.
• Conduct remote and on-site monitoring visits to ensure patient safety, data accuracy, and protocol compliance.
• Document site visits through detailed reports and follow-up letters.
• Assist clinical centers with IRB/EC submissions and maintain study documentation and correspondence.
• Develop and maintain clinical monitoring tracking tools and other study-related documents.
• Contribute to the development of the clinical study Monitoring Plan and create training materials.
• Mentor junior monitors and provide updates to internal clinical teams on monitoring activities.
• Document field reports within prescribed timelines and assist in investigations as necessary.
• Complete required training and adhere to applicable quality system procedures.

Requirements

• High School Diploma or GED required; Bachelor’s Degree in Science preferred.
• Minimum 8 years of experience in clinical research.
• Training and understanding of GCP and 21 CFR 812 required.
• Experience with clinical study documentation, data capture, and IRB processes.
• Ability to travel up to 30% and report on-site to Golden Valley, MN office.

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