Clinical Trial Assistant

Summary:
We are seeking a Clinical Trial Assistant responsible for supporting the initiation and oversight of clinical centers to ensure the successful conduct of active clinical studies. This role involves assisting with qualifying, training, monitoring, and managing clinical centers to ensure adherence to study protocols and regulatory standards. The position is based in Golden Valley, MN, with required on-site presence and travel up to 30%.

Responsibilities:

• Assist in identifying and assessing clinical study centers for participation in trials.
• Support the training of clinical centers on study protocols, data collection, and good clinical practices (GCP).
• Help manage clinical sites, including enrollment monitoring, data quality assurance, and addressing study-related queries.
• Conduct or assist with remote and on-site monitoring visits to ensure patient safety, data accuracy, and protocol compliance.
• Prepare and document site visit reports and follow-up correspondence.
• 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.
• Provide updates to internal clinical teams on monitoring activities and site management.
• 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.