Job Summary:Position is Project Manager for a large multi-site clinical trial. Train and oversee CRA's on the project. Clinical Site is also Coordination Center for the clinical trial. Manage all aspects of the clinical trial at the Sponsor Level including but not limited to: Procuring study drug, site selection and management, vendor selection, consent form development, study document creation, study and data monitoring oversight, SAE and protocol deviation reporting and management, communication and periodic reporting to regulatory agencies and financial sponsors, secure and track all regulatory and financial documents from all sites; critical role in maintaining separation as Site and Coordination Center Candidate must have ability and desire to schedule meetings, write documents, review documents, design CRFs, answer site questions, identify and work with vendors (drug supply, labs, central pharmacy), work with IRBs, consult with biostatisticians, develop study manuals for sites, develop study manual for Coordination Center, develop SAE workflow, develop protocol violation work flow, track study metrics, prepare Investigators Meeting and necessary trainings, develop enrollment plan, prepare reports to DSMB and set up DSMB meetings, review site monitoring reports, conduct study team meetings, schedule and attend Steering Committee Meetings, development of SOPs Candidate must communicate well with PIs, Data Monitors, Data Managers, Monitors including DSMB, vendors, Sites (Nurse, CRA, PI, etc), regulatory and Funding Agencies. Candidate must be organized, have the ability to see big picture as well as small details, good at time management, team oriented, patient, flexible, creative, have the ability to anticipate potential problems and suggest solutions, work well under pressure Candidate with nursing degree would engage in acquisition of blood and urine samples which would be processed, stored, and catalogued for biomarker studies. Candidates with laboratory bench experience would engage in processing of blood and urine samples which would be stored and catalogued for biomarker studies.Minimum Qualifications:
Bachelor's degree and 3 years related experience or equivalent combination of education and experience. SoCRA certified or ACRP certified Experience with clinical research protocols, knowledge of medical terminology, computer skills, and good written/oral communication and organizational skills
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