Healthcare - Clinical Study Specialist IV

4 weeks ago

Neenah, United States Axelon Services Corporation Full time

Clinical Study Specialist IV
Neenah, WI
12 Months
ONSITE

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.

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.
• 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.

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