Site ICRA I

Maple Grove, MN

On-Site Role

$40 - $43 per hour

11-month contract (likelihood of extension)

ABOUT THE ROLE

Our client, a large medical device company, is seeking a Site ICRA I to participate in the planning and execution of clinical studies at assigned study sites in Maple Grove, MN. This role is responsible for supporting timely site activation, ensuring compliance with study protocols, domestic and international Good Clinical Practices, applicable regulatory standards, and Standard Operating Procedures throughout the study lifecycle. The Site ICRA I will collaborate closely with field staff and in-house personnel to manage study start-up, maintenance, and close-out, review informed consent documents, analyze study data, resolve data queries, and address findings from monitoring visits and audits. The position also serves as a primary contact for assigned study sites, facilitates communication, and supports process improvement activities. The role requires strong communication, organizational, and analytical skills, proficiency in Microsoft Office Suite, and the ability to work independently. Familiarity with clinical trials research processes and professional certification are considered desirable. This is an 11-month contract with the likelihood of extension.

WHAT YOU'LL DO

• Support regulatory and clinical protocol compliance for all clinical projects at assigned sites
• Coordinate start-up, maintenance, and close out of clinical study sites in partnership with field staff and in-house personnel
• Review and analyze study data and regulatory documents for accuracy and completeness; resolve data queries and support data corrections
• Follow up and resolve findings from monitoring visits and audits at assigned study sites
• Serve as primary contact and liaison for assigned study sites, responding to protocol-related issues and escalating as appropriate
• Review informed consent documents to ensure all required elements are included
• Apply general clinical research processes and regulatory knowledge to process improvement activities
• Support training of external clinical professionals to ensure compliance with established protocols
• Perform review of site compliance under supervision and escalate issues to site operations management and/or study management
• Update and maintain internal clinical trial information and document management systems, including trial master file management
• Collect and maintain regional and site-specific communication to facilitate activation and execution of clinical studies
• Contribute to global or regional process improvements as needed
• Engage in continuing education and participate in relevant professional associations or societies related to clinical research
• Perform additional duties as assigned

WHAT YOU BRING

• Bachelor’s degree in natural science, pre-medicine, nursing, bioengineering, or related field (or equivalent combination of education and experience)
• Minimum of two years of relevant experience in clinical research or related area
• Strong written and verbal communication, interpersonal, presentation, analytical, and organizational skills
• Ability to interpret basic clinical data and meet deadlines
• Proficiency in Microsoft Office Suite
• Ability to work independently and seek guidance when necessary
• General familiarity with clinical trials research processes
• Previous experience in clinical or corporate research or relevant clinical/hospital environment
• Certification as a Research Professional (SoCRA or ACRP) preferred
• Excellent organization, coordination, accuracy, and attention to detail
• Capable of exchanging information, asking questions, and checking for understanding
• Engagement in relevant professional associations or societies and commitment to continuing education

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