Cerebrovascular Laboratory Research Associate (Global Study Coordinator)
Cerebrovascular Laboratory Research Associate (Global Study Coordinator)
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Job Description
The University of Iowa Department of Neurology is seeking a Research Associate to act as the main point of contact for several national and international research phase 2-3 projects and clinical trials. This position will oversee communication and documentation management for participating sites as well as be responsible for key operational tasks and forecasting and managing studies in conjunction with the study manager.
Job Duties Include:
Act as the main point of contact for daily study activities.
Coordinate with sites for regulatory document collection and completeness.
Manage imaging collection workflows and ensure data accuracy.
Oversee the reporting of side effects and alerts in coordination with the Program Manager.
Communicate randomization strategies to sites in coordination with the Program Manager.
Rotate responsibility for answering calls and questions from recruiting sites.
Address data queries and ensure clinical data integrity.
Design and implement tools to track study progress and documentation.
Lead data capture initiatives and propose innovative solutions.
Prepare documentation for audits and inspections under Program Manager supervision.
Design and distribute newsletters and study updates.
Maintain regular communication with sites and internal teams.
Collaborate actively in the preparation of training materials for sites.
Assist in protocol writing and document preparation.
Become proficient in all aspects of clinical trial operations.
Responsible of the enrollment management: Maintain screening logs screen-fail analysis recruitment plans and site scorecards.
Help with the global training plan/SOPs; certify investigators/coordinators; maintain training logs and re-training after amendments.
Maintain the EDC ownership: User provisioning data entry timeliness query aging missing forms and SDV/SDR status.
Help with the data quality loop: Query resolution edit checks protocol deviation adjudication recons (SAE labs imaging IxRS).
Maintain the safety: SAE/UADE intake & 24-hour clock SUSAR reporting narratives safety letters distribution.
DSMB/CEC support: Datasets blinded listings meeting logistics minutes and action follow-up.
Progress toward independent management of study components.
Design data capture tools using REDCap or other platforms.
Responsible for imaging collection workflows.
Ensure functionality and reliability of imaging collection and storage tools.
Keep track of study documentation and site communications.
Create and maintain tools to monitor documentation status and site engagement.
Lead engagement initiatives for the DIRECTprogram.
Collaborate actively in the preparation of training materials for recruiting sites.
Support reporting of side effects and alerts in coordination with the Program Manager.
Percentage of Effort: 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.
The Cerebrovascular and Neurointerventional Research Laboratory is dedicated to pioneering advancements in the field of Neurointerventional surgery. Our research team is deeply committed to enhancing clinical practices and outcomes for patients suffering from a spectrum of cerebrovascular disorders including stroke aneurysmal subarachnoid hemorrhage unruptured aneurysms carotid artery disease cerebral venous sinus thrombosis (CVST) and other related conditions. Through our focused clinical research we strive to forge new frontiers in endovascular treatments and patient care.
Required Qualifications
Bachelors degree or an equivalent combination of education and experience. Neuroscience-related or Nursing degree preferred.
Minimum 1 year research experience. Project management or clinical trials experience preferred.
Prior experience and competence with clinical research techniques including manuscript writing data curation EDC familiarity imaging file administration and transfer imaging analysis and adjudication and team management.
Experience coordinating logistics managing timelines and communicating across teams and stakeholders.
Excellent interpersonal skills and the ability to communicate (written and spoken) effectively with vendors collaborators patients and their families.
Desired Qualifications
Masters Degree in Neuroscience or Nursing
Prior experience in clinical research with patient or basis scientific data with demonstrated interest in the field of cerebrovascular diseases.
Knowledge of IRB processes Good Clinical Practice (GCP) and clinical trial conduct.
Bilingual (English/Spanish) fluency
Demonstrated organizational skills and attention to detail
Please attach a CV and cover letter (under submission relevant materials) 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 5 professional references will be requested at a later step in the recruitment process.
For additional questions please contact Erin Curry at or .
Required Experience:
IC
Employment Type
Full Time
