University of Iowa · 13 hours ago
Neurology Research Associate - Global Study Coordinator
University of Iowa is seeking a Neurology Research Associate to act as the main point of contact for national and international research projects in the Department of Neurology. This role includes overseeing communication and documentation management, tracking study progress, and ensuring compliance with regulations and guidelines.
EducationHigher EducationUniversities
Responsibilities
Serve as the primary point of contact for participating investigators and research sites for both trials
Independently assess and respond to protocol eligibility questions and operational inquiries; escalate complex clinical or protocol deviations to the Principal Investigator or Lab Leadership as appropriate
Coordinate site onboarding and activation, including feasibility support, investigator engagement, and trial initiation activities
Monitor site-level and global trial metrics (e.g., enrollment performance, data timeliness, protocol adherence)
Implement and track corrective and preventive action plans for underperforming or non-compliant sites
Ensure consistent execution of trial procedures across institutions and geographic regions
Draft and submit medical narratives and documentation for Serious Adverse Events (SAEs) and other safety reports, synthesizing clinical source data into regulator-ready submissions
Maintain the Trial Master File (TMF) in a state of continuous inspection readiness in accordance with ICH-GCP standards
Ensure compliance with federal regulations, ICH-GCP guidelines, sponsor requirements, and University of Iowa / OVPR policies
Support IRB submissions, continuing reviews, amendments, and regulatory correspondence
Assist with internal audits, external monitoring visits, and regulatory inspections as required
Oversee clinical data quality and completeness across both trials, including review of key outcome measures (e.g., NIHSS, modified Rankin Scale)
Perform logic and consistency checks and coordinate timely query resolution with sites
Develop, implement, and maintain Standard Operating Procedures (SOPs) to ensure continuity, consistency, and reproducibility across trials
Support long-term operational stability over the anticipated 3.5-year study period, including personnel transitions and site turnover
Collaborate with study leadership on interim reporting, milestone deliverables, and study close-out activities
Qualification
Required
Bachelor's degree or an equivalent combination of education and experience
Minimum 1 year research experience
Experience coordinating multi-site clinical research studies
Working knowledge of ICH-GCP guidelines, clinical research regulations, and IRB processes
Experience with safety reporting, regulatory documentation, and clinical trial documentation management
Strong organizational skills and the ability to manage multiple complex priorities simultaneously
Excellent written and verbal communication skills
Preferred
Degree in neuroscience, health science, nursing, life science, or public preferred
Project management or clinical trials experience preferred
Experience coordinating investigator-initiated trials preferred
Master's degree in clinical research, public health, nursing, or related field
Background in healthcare or clinical setting (e.g., nursing, allied health, clinical research, etc.)
Experience with national or international clinical trials
Familiarity with neurologic or stroke-related clinical research
Experience maintaining Trial Master Files and preparing regulatory-ready documentation
Company
University of Iowa
On our beautiful campus spanning the Iowa River, our faculty and staff enjoy access to an array of cultural, educational, and recreational activities.
H1B Sponsorship
University of Iowa has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (353)
2024 (300)
2023 (244)
2022 (217)
2021 (201)
2020 (193)
Funding
Current Stage
Late StageTotal Funding
$2.5MKey Investors
Windgate Foundation
2022-08-17Grant· $2.5M
Leadership Team
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