Neurology Research Associate - Global Study Coordinator

UIOWA•Iowa City, IA

About The Position

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, end 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.

Requirements

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 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

Nice To Haves

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.

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.