Clinical Study Specialist IV

Here are the job details for your review:


Job Title: Healthcare - Clinical Study Specialist IV


Pay Rate: $40/hr on W2,


Duration: 12 Months


Job Location: 1995 Marathon Ave, Neenah, WI 54956

Notes:


We need 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.

Job Description:


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.