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HERC: Metro New York & Southern Connecticut Study Coordinator in Bronx, New York

Employer Name: Albert Einstein College of Medicine

We are seeking a Study Coordinator for clinical trials on human immunodeficiency virus (HIV) and herpes prevention. Our research involves the testing of microbicides, drugs in development which are formulated as gels, rings or tablets for vaginal application to prevent the transmission of HIV and other sexually transmitted infections. The research also focuses on defining the factors that contribute to genital tract immunity in healthy and HIV-infected women. The Study Coordinator will be part of the Microbicide Research Team to facilitate clinical and translational research for a broad variety of investigators for NIH-funded and industry-sponsored studies. Under the direction of the PI, the individual will oversee project planning, assist investigators with pre-study set up, participate in implementation and study conduct, and ensure adherence to study protocols and regulatory requirements. Provide key support to multiple investigators, data managers and clinical staff in planning and coordination of research study protocols Create and refine research protocols to ensure compliance and improve protocol coordination Ensure successful conduct of clinical research protocols that adhere to Best Practices and achieve maximum scientific information, while maintaining patient safety and confidentiality Assist and coordinate all IRB-related activities Create regular reports for the IRB, funder (NIH), and data safety monitoring boards Coordinate and conduct data and specimen collection, data entry, and data management Prepare and track application approvals Assist with IND/IDE application preparation Register studies at ClinicalTrials.gov Complete trainings and remain current with Best Practices in clinical research May occasionally act as principal administrative liaison for the project Assist with overseeing participant recruitment, tracking, and follow-up Assume responsibility to ensure issues/concerns will be addressed and monitor them through conclusion Identify, define and analyze information and situations before recommending a course of action Seek to apply technology and innovation to improve efficiency and solve problems Effectively manage own time and resources Interact and proactively share information with internal and external contacts where appropriate