Neurology Research Associate Global Study Coordinator

Iowa, IA - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

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 Neurologys Cerebrovascular and Neurointerventional 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.

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:

Dr. Santiago Ortega-Gutierrez MD MS

Clinical Professor of Neurology Neurosurgery and Radiology

University of Iowa Health Care

Pay Grade: 4A - of Time: 100%

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:

Bachelors 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

Desired Qualification:
Masters 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.

Please attach a resume as part of the application process. Job openings are posted for a minimum of 7 calendar days. This job may be removed from posting and filled any time after the minimum posting period has ended.

Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to five (5) professional references may be requested at a later point in the recruitment.

If your H-1B petition is subject to the September 19 2025 Presidential Proclamation please note that the department will not cover the $100000 payment associated with H-1B sponsorship either at the time of hire or for international travel purposes. We encourage you to explore alternative pathways for work authorization. Our team is available to help identify options that may be suitable for your situation.

Please direct questions to Lydia Davidson at

Additional Information

Compensation

Contact Information

Required Experience:

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 Neurologys Cerebrovascular and Neurointerventional close collaboration with Principal Investigator (PI) Dr. Santiago Ortega Gutier...

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:

Dr. Santiago Ortega-Gutierrez MD MS

Clinical Professor of Neurology Neurosurgery and Radiology

University of Iowa Health Care

Pay Grade: 4A - of Time: 100%

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:

Bachelors 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

Desired Qualification:
Masters 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.

Please direct questions to Lydia Davidson at

Additional Information

Compensation

Contact Information

Required Experience:

Key Skills

Laboratory Experience
ELISA
Immunoassays
Mammalian Cell Culture
Biochemistry
Cell Biology
Research Experience
Cell Culture
Molecular Biology
Microscopy
Research Laboratory Experience
Western Blot

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