Clinical Study Specialist IV

Clinical Study Specialist IV Neenah, WI- ONSITE 10 Months $40 per hour Hours will vary based on business needs and are NOT guaranteed (some weeks they could work 20-30 hours, some weeks they could work zero hours). Candidates must be aligned to this flexible working schedule (Mon-Fri). We are needing someone who is available AT LEAST 3 days a week (HIGHLY PREFERED they are available all 5 days, Monday-Friday). Anyone looking for less than 3 days/ week should not be submitted. Typical office hours are between 7am-4pm. A Clinical Study Specialist is a professional who will coordinate and oversee clinical operations of research projects. This person will assess and evaluate subjects/subject safety. In compliance with established clinical research organizational policies/procedures, Good Clinical Practices plan, will conduct clinical research protocols. This person will work under the general supervision of the Principal Investigator/Clinical Research Manager (PI/CRM) responsible for the clinical studies. Duties and Responsibilities: " Obtain and review records for potential research subjects; maintain study records of research subjects that include documentation of study procedures and progress of research study subjects, following guidelines set forth by the protocol sponsors. " Review recruited clinical study subjects for eligibility; schedule appointments and interviews and evaluate potential subjects. " Instruct potential research subjects and responsible family members, nursing staff, and ancillary staff involved in research on the study procedures, treatments, and side effects. " Educate subjects concerning protocol and explain informed consent procedures, including obtaining subjects written consent. " Evaluate and assist in developing subject education materials and give subjects and/or family members instruction on test article administration and other study information. " Perform nursing assessments and monitor subjects' progress during clinical studies and notify PI/CRM of any adverse events and serious adverse events, including evidence of unexpected side effects. " Perform initial interview during each subject visit and plan appropriate procedures according to the protocol. " If study requires instrumentation, set-up and verify instruments and conduct study with instruments. Assemble instrument data for study analysis " Troubleshoot simple equipment or instrumentation issues if necessary " Coordinate research activities and procedures for study subjects. " Complete case report forms for each study participant and document study data in subject study file. " Assess and document compliance of research subjects. " Provide orientation, information, training/cross-training, and assistance for new/existing personnel and research assistants, study staff to the research activities. Participate in staff meetings and in-service education. " Maintain adequate inventory of research supplies necessary for research activities. " Maintain exam rooms and laboratory. Qualifications: " Licensed health care professional such as RN, LPN or radiological technologist. " One year of licensed or registered professional health care experience in a Clinical Research setting preferred. Excellent oral and written communication skills. High degree of empathy for subjects. Ability to work independently. Strong problem-solving abilities. Understands OSHA guidelines for handling hazardous biological and chemical materials.