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Job Description Summary
Clinical Research Coordinator (CRC) to coordinate and perform daily clinical research activities in accordance with approved protocols administered by the non-cancer Clinical Trials Management Organization for Huntington’s Disease research within the Division of Cognitive Neurology, supporting the Center of Cognitive and Memory Disorders in the Department of Neurology. CRC assists with assessing patient records to identify patients who are eligible to participate in specified clinical research protocols; recruits, interviews and enrolls patients; obtains informed consent and ensures consent process is administered in compliance to regulatory and sponsor requirements; educates patients and families of purpose, goals, and processes of clinical study; coordinates scheduling and follow-through of patient care appointments, procedures, & other diagnostic testing in accordance with study protocol; participates in the collection, processing & evaluation of biological samples; administers, evaluates and calculates standardized scoring of diagnostic, psychological or behavioral testing or questionnaires; assists with monitoring patients for adverse reactions to study treatment, procedure or medication and notifies appropriate clinical professional to evaluate patient response, identify status of complications, & provide appropriate level of care; documents unfavorable responses and notifies research sponsors & applicable regulatory agencies; participates in evaluating patients for compliance related to protocol; assists with collecting, extracting, coding, and analyzing clinical research data; generates reports and reviews to ensure validity of data; supports activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations; assists with coordinating and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors; participates in activities to develop new research protocols and contributes to establishment of study goals to meet protocol requirements.
Additionally, this position will draft and maintain IRB submissions, including initial applications, amendments, and continuing reviews; manage informed consent language and documentation across multiple protocols; coordinate with compliance offices, research administration, and sponsors to ensure adherence to institutional, federal, state, FDA, and industry requirements; and assist with preparation for external audits and quality assurance reviews; organize, curate, and quality control longitudinal neuroimaging datasets for Huntington’s Disease cohorts; harmonize subject identifiers, visit structures, and metadata across studies and timepoints; maintain REDCap and related database structures supporting clinical, imaging, and biomarker data; perform data versioning and preparation of analysis ready datasets to support reuse across manuscripts, grants, and multi study analyses; interface with neurology, other departments, and imaging teams to coordinate imaging pipelines; manage secure data transfers, track processing runs and failures, troubleshoot pipeline issues, and document workflows to ensure reproducibility across publications and grant submissions; prepare and curate datasets for statistical and machine learning analyses; translate clinical and imaging variables into analysis ready and machine learning–ready formats; manage data access, updates, and version control; track analyses, milestones, and deliverables across imaging and computational initiatives; support imaging and clinical manuscripts through data verification, cohort table generation, figure reproducibility, and revision tracking; assemble pilot data, tables, and figures for internal funding applications and external grant submissions; coordinate data sharing, timelines, and documentation with collaborating sites; harmonize data definitions and documentation to ensure consistent data transfer, storage, security, and use across sites; and participate in the development of new research protocols, contributing to study goals and operational plans to meet protocol requirements.
Minimum Education Requirement
Bachelor’s Degree in Biological Sciences, Health Sciences, Social Sciences or other medical field, or equivalent combination of education experience required.
Preferred Education
Master's degree preferred.
Experience Requirement
1 year of relevant experience required.
Experience Preferred
2-4 years of relevant experience preferred. Experience working with longitudinal datasets, neuroimaging data, REDCap, and database management strongly preferred; demonstrated interest or experience in data management, statistical analysis, scripting (e.g., Python, R, MATLAB), or machine learning applications in clinical research preferred; familiarity with data harmonization, version control, or reproducible research workflows is desirable; clinical research certification from an accredited certifying agency desired (ACRP or SOCRA)
Requires successful completion of a background check. Qualified candidates may be requested to complete a pre-employment physical, including a drug screen.
FUNCTION/SUBFUNCTION: Research and Scholarship/Clinical Research
CAREER BAND: Individual contributor- Specialized
CAREER LEVEL: S2
Key Responsibilities Summary
• Primary coordination of Huntington’s Disease clinical research activities, including longitudinal observational, imaging, biomarker, and clinical trial studies
• Support Division of Cognitive Neurology clinical research initiatives, including departmental clinical trial activities as assigned
• Manage IRB and regulatory submissions across multiple protocols
• Curate longitudinal imaging and clinical datasets for reuse and analysis
• Coordinate imaging pipelines and data transfers across departments
• Support computational, manuscript, and grant activities
• Facilitate multi‑site data harmonization and collaboration
Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.
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