Research Assistant, Clinical Research Service Center, 60% Wayne State University is searching for an experiencedResearch Assistant, Clinical Research Service Center, 60%at its Detroit campus location. Wayne State is a premier, public, urban research university located in the heart of Detroit, Michigan where students from all backgrounds are offered a rich, high-quality education. Our deep-rooted commitment to excellence, collaboration, integrity, diversity and inclusion creates exceptional educational opportunities which prepare students for success in a global society. Position Purpose: 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 at 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. Essential Functions: Review and monitor research databases compared to original data create queries and ensure queries are resolved for multisite clinical research study using REDCap (Research Electronic Data Capture) and OnCore (clinical research management system). Communicate with sites on study monitoring progress. Independently create source documents for studies across disciples. Conduct sample collection, IV starts and phlebotomy, medication administration, EKG’s(electrocardiograms), monitor vital signs, facilitate research study specific procedures such as biopsies and ECHO’s(echocardiograms), other procedures as required by the protocols and documentation. Assist with investigational product administration, verification and 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 in both pediatric and adult studies. Maintain and update research center standard operating procedures to be in compliance with Good clinical practices and international conference of Harmonization clinical research regulations. Perform other related duties as assigned. Unique Duties: Physical Requirements: Frequently stand, walk, bend, squat, perform desk-based computer tasks. Occasionally lift and handle weight up to 20 pounds. Push and/or pull up to 50 pounds. Minimum Qualifications: Education: Bachelor’s degree Bachelor’s degree in nursing preferred. CITI certified (Collaborative Institutional Training Initiative), OnCore, REDCap and Advarra EDC (Electronic Data Capture platform) training required. Experience Expert (established subject matter expert, 7+ years experience). Experience performing clinical research protocol procedures, creating source documents, regulatory management, and monitoring multisite trials. Working knowledge of Advarra eREG (Electronic regulatory compliant platform), OnCore, EDC(Electronic Data Capture) and REDCap as well as basic computer programs (WORD, EXCEL). Knowledge, Skills and Abilities: Ability to work independently. Ability to troubleshoot unplanned situations while still performing everyday tasks. Excellent time management and organizational skills. Excellent interpersonal and communication skills and demonstrated ability to work with others in a collaborative environment. Microsoft office software skills. School/College/Division: The Division of Research & Innovation Primary Department: H0905 - VP Research Employment Type: + Regular Employee + Job type: Fractional Time + Job category: Research Funding/salary information: + Compensation type: Annual Salary + Salary minimum: To be determined Working Conditions: Typical work environment may include a clinical research center and/ or office environment. May require working non-standard business hours including evenings and weekends. Job Openings: + Number of openings: 1 + Reposted position: No Background check requirements: University policy requires certain persons who are offered employment to undergo a background check, including a criminal history check, before starting work. If you are offered employment, the university will inform you if a background check is required. The university welcomes applications from persons with disabilities and veterans. Wayne State is an equal opportunity employer.