University of Rochester Human Subject Research Coordinator - 228558 in Rochester, New York
Human Subject Research Coordinator Job ID 228558Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening
Full Time 40 hours Grade 051 Cancer Center M&DSchedule
8 AM-4:30 PMResponsibilities
Coordinates the activities associated with human subject research and data management for Dr. Nikesha Gilmore and Erika Ramsdale research studies.
Coordinates the administrative details required to initiate and conduct human subject research, such as, receiving, distributing, and explaining study information, including protocol, and human subject recruitment materials (i.e., brochures, advertisements, newsletters, etc.) to immediate team members and relevant others.
Ensures all immediate and extended team members understand and adhere to all aspects of all approved protocols, procedures and standards for documentation and communication. Under general direction from the Principal Investigator and senior research staff members, trains staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, process for source documentation, and adverse event reporting.
Reviews and documents the dispensing and returning of study materials. Ensures additional training is provided to ensure changes to protocol and documents are communicated and adhered to.
Assists in human subject recruitment and screening activities, including reviewing study site patient databases and office records for patients that meet the protocol inclusion criteria. May participate in developing recruitment strategies. May conduct telephone interviews to screen potential study candidates. Reviews medical chart history to verify inclusion criteria are met before enrollment.
Conducts visits to ensure research participant adherence with protocol requirements such as proper use of device and/or other interventional activities; to conduct qualitative interviews with participants; to document adverse events and report to senior study staff, Principal Investigator (PI), Institutional Review Board (IRB), Sponsor and/or any other required recipients or entities; and to ensure all data are collected and secured within approved parameters and procedures.
Organizes data collection and data management activities through transcribing and coding qualitative data, building databases for quantitative data (REDCap), and participating in activities reviewing quality of data. Presents at team meetings. Participates in analysis and organizing of study reports and scientific communication (e.g., presentations, manuscripts)
Acts as liaison with Sponsor’s Monitor: to provide data clarifications, to review study protocols, to ensure thorough understanding and communication, to respond to questions that arise during the study, to communicate and document adverse events as advised by the Principal Investigator, and to ensure regulatory and other documents (such as consent forms and CRFs) are complete, accurate and available for review. Communicates with Sponsor to clarify data queries to determine report format.
Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures and guidelines, and makes recommendations. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines. Keeps current with industry standards, best practices, trends in therapeutic areas relevant to research studies; makes recommendations and implements changes as appropriate.
Other duties as assigned
Qualifications:Bachelor's degree; or equivalent combination of education and experience required. Knowledge of word processing and data analysis software preferred.How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled