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Clinical Research Assistant

Posted by: Melissa, Dell Technical Group

Posted date: 2016-Oct-11

Location: Neenah, WI

Job Summary 
A Clinical Research Coordinator 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 HIPAA authorizations and obtain 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. 
 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. 
 Act as principal investigator's representative as appropriate. 
 Maintain subject database information. Work with analysts and assist with queries related to data to evaluate the significance of compiled data. 
 Provide orientation, information, training/cross-training, and assistance for new/existing personnel and research assistants, study staff to the research activities. 
 Participate in contractor staff meetings and in-service education. 
 Maintain adequate inventory of research supplies necessary for research activities. Maintain exam rooms and laboratory. 

 Certified Medical Assistant or Certified Nursing Assistant 
 One year of professional health care experience 
 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

Job Title Clinical Research Assistant
Post Details
Posted By Melissa, Dell Technical Group
Job Function
Start Date
Email melissah(at)dell-tech.com
Location Neenah, WI
Job Type
Classification Job Classification -> Medical