Essential Functions: To hire a research assistant to assist Investigator in pharmaceutical and investigator initiated research studies conducted in the clinical research service center. Provide scientific and technical assistance in the implementation of clinical trials conducted the Wayne state University clinical research service center. Assist in writing and submitting human subject research protocols. Implement all aspects of research protocols/procedures independently or as directed through training in more difficult or specialized procedures to meet the needs of the research protocol.Assist investigators in sample collection, IV starts and phlebotomy, medication administration, EKG's, monitor vital signs, facilitate research study procedures, other procedures as required by the protocols and documentation. Assist with Physical Exams and study drug adverse event assessment. Capture Medical History and ongoing con-meds. Conduct Follow up phone call.Assist in the creation and submission of human subject research clinical studies to the study sponsor. Ability to review scientific protocols for the purpose of developing informed consent and protocol summary documents, amendments, reviewing adverse events, tracking of human subject renewal.Assist in participant recruitment and consenting, and implementation of study procedures as outlined in the protocol. Specimen collection and processing, source document creation, data entry and query resolution in the sponsor databases. Review and coordinate presentation of study protocol procedures to the study team. Study enrollment data entry into Oncore.Other duties as assigned.
Qualifications: Bachelor's degree required in Nursing / Health Care.Expert (established subject matter expert, 7+ years experience)Experience working in clinical research setting to collect bio specimens, vital signs and research data.Working knowledge of OnCore Clinical Trials management software and REDCap.Excellent command of the English language, strong command of medical terminology.Excellent writing skills with ability to understand research protocols.Proficient in computer software utilization Microsoft office (Excel, Word).Comfortable working and learning new research required software for data capture.Understanding of IRB and FDA requirements for implementing research studies.Detail oriented, strong interpersonal skills and strong organizational skills.
Founded in 1868, Wayne State University is a nationally recognized metropolitan research institution offering more than 400 academic programs through 13 schools and colleges to nearly 32,000 students. Wayne State?s main campus in Midtown Detroit comprises 100 buildings over nearly 200 acres; its five extension centers offer higher education to people throughout Southeast Michigan. Wayne State is dedicated to preparing students to excel by combining the academic excellence of a major research university with the practical experience of an institution that by its history, location and diversity represents a microcosm of the world we live in. Reflecting its location and the excellent international reputation of its graduate schools, particularly in the sciences, Wayne State boasts the most diverse student body among Michigan?s public universities. Its students represent 49 U.S. states and more than 60 countries.