Clinical Study Specialist
- Neenah, WI
- Contract
- Full-time
- 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.
- Licensed health care professional such as RN, LPN or radiological technologist.
- Minimum 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.