Human Subject Research Specialist II jobs in United States
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URMC Department of Psychiatry ยท 2 days ago

Human Subject Research Specialist II

The University of Rochester is committed to a culture of equity and integrity, and they are seeking a Human Subject Research Specialist II to coordinate research studies in the Psychiatry Department. This role involves overseeing human subject research activities, participant recruitment, training research staff, and ensuring compliance with regulatory standards.

Mental Health Care

Responsibilities

Oversees, coordinates and conducts human subject research activities for single or multiple sites
Recruits and enrolls participants
Develops, implements and evaluates recruitment strategies, materials, information and data systems, as well as study management systems
Follows up with study participants regarding assessments and document communications, including protocol deviations
Trains research staff (e.g., student RAs; new fulltime staff) about activities associated with conducting human subject research specific to study protocols and generally in compliance with Good Clinical Practice (GCPs) guidelines and sponsor requirements
Directs the activities of subordinate staff and relevant others to gather, compile and analyze study information
Develops, implements and monitors systems and methods to ensure quality, safety, efficiency and consistency in the processing of human subject research data
Reviews study progress, conducts data quality checks monthly, ensures data files are updated in a proper timeframe, codes data, cleans data, creates databases for manuscript preparation
Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures, guidelines, and implements and monitors resulting study changes
Demonstrates accountability for continuous learning in accordance with Good Clinical Practice guidelines
Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies and designs, implements and monitors resulting study changes

Qualification

Human subject research coordinationData managementSPSSClinical Practice (GCP)Participant recruitmentSupervisory skillsWord processingExcelProfessional Research Coordinator Certification

Required

Bachelor's degree Required
2 years of experience in human subject research coordination Required
or equivalent combination of education and experience Required
Word processing, Excel, and data analysis software (e.g., SPSS) Required

Preferred

Experience as Human Subject Research Coordinator Preferred
Professional Research Coordinator Certification (SoCRA or ACRP) Preferred
SOCRA - Certification In Clinical Research upon hire preferred
Association of Clinical Research Professionals (ACRP) upon hire preferred

Company

URMC Department of Psychiatry

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We strive to be an international leader in clinical care, community service, education, and research.

Funding

Current Stage
Late Stage
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