Neurology Research Associate - Global Study Coordinator

Neurology Research Associate - Global Study Coordinator

The Global Study Coordinator (GSC) acts as the main point of contact for several national and international research phase 2-3 projects and trials for the Department of Neurology’s Cerebrovascular and Neurointerventional Laboratory. In close collaboration with Principal Investigator (PI) Dr. Santiago Ortega Gutierrez, this position oversees communication and documentation management for participating sites.

This role is responsible for key operational tasks, including tracking study progress documentation, maintaining regular communication with external and internal teams, and ensuring the functionality and reliability of collection and storage tools. Specifically, the GSC oversees CROs, CRAs, and vendors (e.g., IRT, labs, imaging). The GSC is expected to forecast and manage each study in conjunction with the respective study manager, lead global training and amendment rollouts, and run the operational cadence (e.g., huddles, dashboards, governance reviews).

Additionally, this position manages EDC health (i.e., timely entry, queries, SDV/SDR) and reconciles key datasets (i.e., SAE, labs, imaging).

The GSC tracks and acts on KPIs (e.g., activation, enrollment, data quality, deviations, CAPAs), coordinates close-out and archiving, and keeps investigators, country leads, and sponsor leadership aligned from first-patient-in through database lock and CSR.

Responsibilities Include:

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.

Principal Investigator: Clinical Professor of Neurology, Neurosurgery, and Radiology

Please note: This is a specified term position that will last 12 months. An extension may be reviewed after the initial 12 months but is not guaranteed.

Required Qualifications:

• Bachelor’s degree or an equivalent combination of education and experience. Degree in neuroscience, health science, nursing, life science, or public preferred.
• Minimum 1 year research experience. Project management or clinical trials experience preferred
• Experience coordinating multi-site clinical research studies. Experience coordinating investigator-initiated trials preferred.
• Working knowledge of ICH-GCP guidelines, clinical research regulations, and IRB processes.
• Experience…