Essential Functions: The Research Assistant will assist with all aspects of implementation of clinical research studies in the Wayne State University clinical research center under the direction of the physician as well as implement all aspects of research protocols independently or as directed through training in more difficult or specialized procedures to meet the needs of the research protocol.Protocol Development and implementation:Assist in the development and creation of clinical research protocol using NIH grants or pharmaceutical protocols.Develop denovo informed consents, protocol summary and survey/questionnaires.Assist investigator with writing methods and summarizing participant data for human subject research in annual reports and protocol amendments.Ensure all study team members are trained on research study amendments.Assist investigator to maintain compliance with regulatory and protocol procedures during study conduct and data capture.Assist physicians, nurses, pharmacist, research staff, IRB personnel, sponsor personnel to collect and enter all required research data in sponsor database according to FDA requirements.Assist in the conduct of study procedures at participant visits as required by investigator based on study protocol.Review and submit capture per FDA , NIH, DOD and HRPO at study initiation and for the duration of the study. (e.g. CITI, FDA 1572, laboratory ranges, licensure).Review and capture data into the university's clinical research databases for research studies inclusive of but not limited to OnCore and E-Regulatory as soon as human subject approval is obtained and for the duration of the study.Be very knowledgeable of human subject research per federal regulations and ICH for data capture and study implementation through literature searches.Perform other related duties as assigned.
Qualifications: Bachelor's degree required Health Science or Science. CITI certified.Research Certification Preferred (e.g., ACRP, SOCRA).Experience Intermediate (3 to 4 years job-related experience)In conduct of clinical trials from pharmaceutical and federal funding agencies In submission of human subject research and protocol creation.Research Certification Preferred (e.g., ACRP, SOCRA).Experience - Intermediate (3 to 4 years job-related experience)In conduct of clinical trials from pharmaceutical and federal funding agencies In submission of human subject research and protocol creationAbility to read and understand human subject grants and pharmaceutical protocols Ability to conduct multiple projects, prioritize work load and meet deadlines.Ability to analyze, summarize and interpret research data in reports and spreadsheets.Excellent command of the English language, working knowledge of FDA/ICH research terminology as well as scientific and/or medical terminology.Excellent writing skills and proficient in literature searches Proficient in data capture and data entry.Detail oriented and strong organizational skills.Proficient in computer software utilization Microsoft office (Excel, Word, Access) Comfortable working and learning new databasesWorking knowledge of Oncore and eREG clinical research system very desirable
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.