Clinical Study Specialist IV

About the job Clinical Study Specialist IV


Work Location: Neenah South Office (Onsite) (This is NOT a remote position)
Job Title: Clinical Study Specialist IV

Job Description

This position is onsite at the Neenah South Office. Hours will vary based on business needs and are not guaranteed (some weeks may be 2030 hours, other weeks may be zero hours). Candidates must be aligned with a flexible work schedule (MondayFriday). Availability of at least 3 days per week is required , with strong preference for availability all 5 days (MondayFriday). Candidates seeking less than 3 days per week should not be submitted. Typical office hours are between 7:00 AM and 4:00 PM .

A Clinical Study Specialist coordinates and oversees the clinical operations of research projects. This role involves assessing and evaluating study subjects and subject safety, and conducting clinical research protocols in compliance with established clinical research policies, procedures, and Good Clinical Practice guidelines. This position works under the general supervision of the Principal Investigator and/or Clinical Research Manager responsible for the studies.

Duties and Responsibilities

• Obtain and review records for potential research subjects; maintain study records documenting study procedures and subject progress in accordance with protocol guidelines.
• Review recruited study subjects for eligibility; schedule appointments and interviews and evaluate potential participants.
• Instruct research subjects, responsible family members, nursing staff, and ancillary staff on study procedures, treatments, and potential side effects.
• Educate subjects regarding protocol requirements and explain informed consent procedures, including obtaining written consent.
• Assist in developing subject education materials and provide instruction on test article administration and other study-related information.
• Perform nursing assessments and monitor subject progress during clinical studies; notify the Principal Investigator/Clinical Research Manager of adverse events and serious adverse events, including unexpected side effects.
• Perform initial interviews during subject visits and plan appropriate procedures according to protocol.
• Set up and verify instruments when required; conduct studies involving instrumentation and assemble instrument data for analysis.
• Troubleshoot basic equipment or instrumentation issues as needed.
• Coordinate research activities and procedures for study subjects.
• Complete case report forms for each study participant and document study data in subject study files.
• Assess and document compliance of research subjects.
• Provide orientation, training, cross-training, and assistance to new and existing personnel, research assistants, and study staff.
• Participate in staff meetings and in-service education.
• Maintain adequate inventory of research supplies necessary for research activities.
• Maintain exam rooms and laboratory spaces.

Qualifications

• Licensed healthcare professional (e.g., RN, LPN, or radiologic technologist).
• One year of licensed or registered professional healthcare experience in a clinical research setting preferred.
• Excellent oral and written communication skills.
• High degree of empathy for research subjects.
• Ability to work independently with strong problem-solving skills.
• Knowledge of OSHA guidelines for handling hazardous biological and chemical materials.